Diagnostic and Therapeutic Yield of Endoscopy in Patients with Elevated INR and Gastrointestinal Bleeding.

PubMed

Peloquin, Joanna M; Seraj, Siamak M; King, Lindsay Y; Campbell, Emily J; Ananthakrishnan, Ashwin N; Richter, James M

2016-06-01

Gastrointestinal bleeding is a well-known risk of systemic anticoagulation. However, bleeding in the setting of supratherapeutic anticoagulation may have a milder natural history than unprovoked bleeding. It is a common clinical gestalt that endoscopy is common, but bleeding source identification or intervention is uncommon, yet few data exist to inform this clinical impression. Consequently, we sought to examine our institutional experience with gastrointestinal bleeding in the setting of supratherapeutic international normalized ratio (INR) with the aim of identifying predictors of endoscopically identifiable lesions, interventions, and outcomes. A retrospective review was conducted at a tertiary referral academic medical center to identify patients presenting with gastrointestinal bleeding in the setting of warfarin and a supratherapeutic INR (>3.5) who underwent an endoscopic procedure. Relevant clinical covariates, endoscopic findings, need for intervention, and outcomes were collected by review of the medical record. Logistic regression adjusting for potential confounders identified predictors of endoscopically significant lesions as well as intervention and outcomes. A total of 134 patients with INR 3.5 or greater (mean 5.5, range 3.5-17.1) presented with symptoms of gastrointestinal bleeding, most commonly as melena or symptomatic anemia. Antiplatelet agents were used by 54% of patients, and 60% of patients were on concomitant acid suppression on admission. Procedures included esophagogastroduodenoscopy (upper endoscopy; EGD) (n = 128), colonoscopy (n = 73), and video capsule endoscopy (n = 32). Active bleeding at first EGD or colonoscopy was found in only 19 patients (18%), with endoscopic intervention in only 26 patients (25%). At a critical threshold of INR 7.5 at presentation, the likelihood of finding an endoscopically significant lesion fell to <20%. On multivariate logistic regression, concomitant antiplatelet therapy (odds ratio [OR] 2.59; 95% confidence interval [CI], 1.13-5.94), timing of EGD within 12 hours of presentation (OR 3.71; 95% CI, 1.05-13.08), and INR level (OR 0.79; 95% CI, 0.64-0.98) were the only significant independent predictors of identifying a source of bleeding. A risk score incorporating these covariates performed modestly in identifying risk of significant finding on EGD (area under the curve 0.68). We found no association between identification of a significant lesion at EGD and future readmission for gastrointestinal bleeding. This study demonstrates that the relationship between INR elevation and identification of a bleeding source or endoscopic intervention at EGD are indeed antiparallel. Concomitant antiplatelet therapy increases the likelihood of bleeding source identification and intervention, as does EGD within 12 hours of presentation. However, regardless of source identification or endoscopic intervention, important clinical outcomes were unchanged, suggesting that decisions about endoscopy should be made on a case-by-case basis, particularly in patients with INR > 7.5. Future prospective studies on appropriate indications and timing of endoscopy in such patients are warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

The Importance of Rockall Scoring System for Upper Gastrointestinal Bleeding in Long-Term Follow-Up.

PubMed

Bozkurt, Mehmet Abdussamet; Peker, Kıvanç Derya; Unsal, Mustafa Gökhan; Yırgın, Hakan; Kahraman, İzzettin; Alış, Halil

2017-06-01

The aim of the study is to examine the importance of Rockall scoring system in long-term setting to estimate re-bleeding and mortality rate due to upper gastrointestinal bleeding. A total of 321 patients who had been treated for upper gastrointestinal bleeding were recruited to the study. Patients' demographic and clinical data, the amount of blood transfusion, endoscopy results, and Rockall scores were retrieved from patients' charts. The re-bleeding, morbidity, and mortality rates were noted after 3 years of follow-up with telephone. Re-bleeding rate was statistically significantly higher in Rockall 4 group compared to Rockall 0 group. Mortality rate was also statistically significantly higher in Rockall 4 group. Rockall risk scoring system is a valuable tool to predict re-bleeding and mortality rates for patients with upper gastrointestinal bleeding in long-term setting.

A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation.

PubMed

Dai, Ruoxi; Lam, Otto L T; Lo, Edward C M; Li, Leonard S W; McGrath, Colman

2017-06-01

The objectives of this study were to evaluate and compare the effectiveness of an advanced oral hygiene care programme (AOHCP) and a conventional oral hygiene care programme (COHCP) in improving oral hygiene, and reducing gingival bleeding among patients with stroke during outpatient rehabilitation. Subjects were randomized to receive (i) the COHCP comprising a manual toothbrush, toothpaste, and oral hygiene instruction, or (ii) the AOHCP comprising a powered toothbrush, 0.2% chlorhexidine mouthrinse, toothpaste, and oral hygiene instruction. Dental plaque, gingival bleeding, and other clinical oral health outcomes were assessed at baseline, the end of the clinical trial, and the end of observation period. Development of infectious complications was also monitored. Participants of both programmes had a significant reduction in the percentages of sites with moderate to abundant dental plaque (p<0.001) and with gingival bleeding (p<0.05). Those in the AOHCP had significantly less plaque and gingival bleeding than those in the COHCP controlling for other factors at the end of the clinical trial period (both p<0.001) and the observational period (plaque: p<0.05, gingival bleeding: p<0.01). Although both oral hygiene care programmes were effective in terms of plaque and gingival bleeding control, the AOHCP was more effective than the COHCP in reducing dental plaque and gingival bleeding. This study highlighted the value of oral hygiene programmes within stroke outpatient rehabilitation and provides evidence to advocate for the inclusion of oral hygiene care programmes within stroke outpatient rehabilitation for patients with normal cognitive abilities. Copyright © 2017 Elsevier Ltd. All rights reserved.

Risk factors for re-bleeding of aneurysmal subarachnoid hemorrhage: meta-analysis of observational studies.

PubMed

Alfotih, Gobran Taha Ahmed; Li, FangCheng; Xu, XinKe; Zhang, ShangYi

2014-01-01

The mortality of re-bleeding following aneurysmal subarachnoid hemorrhage is high, and surviving patients often have poor clinical condition and worse outcome than patients with a single bleed. In this study, we performed an updated systematic review and meta-analysis to determine the most common risk factors for re-bleeding in this patient population, with the goal of providing neurologists, neurosurgeons, neuro-interventionalists with a simple and fast method to evaluate the re-bleeding risk for aneurysmal subarachnoid hemorrhage. We conducted a thorough meta-analysis of the risk factors associated with re-bleeding or re-rupture of intracranial aneurysms in cases published between 2000 and 2013. Pooled mean difference was calculated for the continuous variables (age), and pooled odds ratio (OR) was calculated for categorical factors. If heterogeneity was significant (p<0.05), a random effect model was applied; otherwise, a fixed model was used. Testing for pooled effects and statistical significance for each potential risk factor were analyzed using Review Manager software. Our literature search identified 174 articles. Of these, only seven retrospective studies met the inclusion criteria. These seven studies consisted of 2470 patients, 283 of which had aneurysmal re-bleeding, resulting in a weighted average rate of re-bleeding of 11.3% with 95% confidence interval [CI]: 10.1-12.6. In this population, sex (OR 1.46; 95% CI: 1.11-1.92), high systolic blood pressure [SBP] (OR 2.52; 95% CI: 1.40-4.53), aneurysm size (OR 3.00; 95% CI: 2.06-4.37), clinical condition (Hunt & Hess) (OR 4.94; 95% CI: 2.29,10.68), and Fisher grade (OR 2.29; 95% CI: 1.45, 3.61) were statistically significant risk factors for re-bleeding. Sex, high SBP, high Fisher grade, aneurysm size larger than 10mm, and poor clinical condition were independent risk factors for aneurysmal re-bleeding. The importance of early aneurysm intervention and careful consideration of patient risk factors should be emphasized to eliminate the risk of re-bleeding and poor outcome. Copyright © 2014 Polish Neurological Society. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Clinical outcome of acute nonvariceal upper gastrointestinal bleeding after hours: the role of urgent endoscopy.

PubMed

Ahn, Dong-Won; Park, Young Soo; Lee, Sang Hyub; Shin, Cheol Min; Hwang, Jin-Hyeok; Kim, Jin-Wook; Jeong, Sook-Hyang; Kim, Nayoung; Lee, Dong Ho

2016-05-01

This study was performed to investigate the clinical role of urgent esophagogastroduodenoscopy (EGD) for acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) performed by experienced endoscopists after hours. A retrospective analysis was performed for consecutively collected data of patients with ANVUGIB between January 2009 and December 2010. A total of 158 patients visited the emergency unit for ANVUGIB after hours. Among them, 60 underwent urgent EGD (within 8 hours) and 98 underwent early EGD (8 to 24 hours) by experienced endoscopists. The frequencies of hemodynamic instability, fresh blood aspirate on the nasogastric tube, and high-risk endoscopic findings were significantly higher in the urgent EGD group. Primary hemostasis was achieved in all except two patients. There were nine cases of recurrent bleeding, and 30-day mortality occurred in three patients. There were no significant differences between the two groups in primary hemostasis, recurrent bleeding, and 30-day mortality. In a multiple linear regression analysis, urgent EGD significantly reduced the hospital stay compared with early EGD. In patients with a high clinical Rockall score (more than 3), urgent EGD tended to decrease the hospital stay, although this was not statistically significant (7.7 days vs. 12.0 days, p > 0.05). Urgent EGD after hours by experienced endoscopists had an excellent endoscopic success rate. However, clinical outcomes were not significantly different between the urgent and early EGD groups.

Potential Harm of Prophylactic Platelet Transfusion in Adult Dengue Patients.

PubMed

Lee, Tau-Hong; Wong, Joshua G X; Leo, Yee-Sin; Thein, Tun-Linn; Ng, Ee-Ling; Lee, Linda K; Lye, David C

2016-03-01

Thrombocytopenia is a hallmark of dengue infection, and bleeding is a dreaded complication of dengue fever. Prophylactic platelet transfusion has been used to prevent bleeding in the management of dengue fever, although the evidence for its benefit is lacking. In adult dengue patients with platelet count <20,000/mm3 without bleeding, we aimed to assess if prophylactic platelet transfusion was effective in reducing clinical bleeding and other outcomes. We conducted a retrospective non-randomised observational study of dengue patients with platelet count < 20,000/mm3 without bleeding (except petechiae) admitted to Tan Tock Seng Hospital from January 2005 to December 2008. Baseline characteristics and clinical outcomes were compared between the non-transfused vs. transfused groups. Outcomes studied were clinical bleeding, platelet increment, hospital length of stay, intensive care unit admission and death. Of the 788 patients included, 486 received prophylactic platelet transfusion. There was no significant difference in the presence of clinical bleeding in the two groups (18.2% in non-transfused group vs. 23.5% in transfused group; P = 0.08). Patients in the transfused group took a median of 1 day longer than the non-transfused group to increase their platelet count to 50,000/mm3 or more (3 days vs. 2 days, P <0.0001). The median duration of hospital stay in the non-transfused group was 5 days vs. 6 days in the transfused group (P< 0.0001). There was no significant difference in the proportion requiring ICU admission (non-transfused 0.66% vs. transfused 1.23%, P = 0.44) and death (non-transfused 0% vs. transfused 0.2%, P = 0.43). Platelet transfusion in absence of bleeding in adult dengue with platelet count <20,000/mm3 did not reduce bleeding or expedite platelet recovery. There was potential harm by slowing recovery of platelet count to >50,000/mm3 and increasing length of hospitalization.

Monitoring and treatment of acute gastrointestinal bleeding.

PubMed

Lenjani, Basri; Zeka, Sadik; Krasniqi, Salih; Bunjaku, Ilaz; Jakupi, Arianit; Elshani, Besni; Xhafa, Agim

2012-01-01

Acute gastrointestinal bleeding-massive acute bleeding from gastrointestinal section is one of the most frequent forms of acute abdomen. The mortality degree in emergency surgery is about 10%. It's very difficult to identify the place of bleeding and etiology. The important purpose of this research is to present the cases of acute gastrointestinal bleeding from the patients which were monitored and treated at The University Clinical Center of Kosova-Emergency Center in Pristina. These inquests included 137 patients with acute gastrointestinal bleeding who were treated in emergency center of The University Clinical Center in Pristina for the period from January 2005 until December 2006. From 137 patients with acute gastrointestinal bleeding 41% or 29% was female and 96% or 70.1% male. Following the sex we gained a high significant difference of statistics (p < 0.01). The gastrointestinal bleeding was two times more frequent in male than in female. Also in the age-group we had a high significant difference of statistics (p < 0.01) 63.5% of patients were over 55 years old. The mean age of patients with an acute gastrointestinal bleeding was 58.4 years SD 15.8 age. The mean age for female patients was 56.4 age SD 18.5 age. The patients with arterial systolic pressure under 100 mmHg have been classified as patients with hypovolemic shock. They participate with 17.5% in all prevalence of acute gastrointestinal bleeding. From the number of prevalence 2 {1.5%} patients have been diagnosed with peptic ulcer, 1 {0.7%} as gastric perforation and 1 {0.7%} with intestine ischemia. Abdominal Surgery and Intensive Care 2 or 1.5% died, 1 at intensive care unit and 1 at nephrology. As we know the severe condition of the patients with gastrointestinal bleeding and etiology it is very difficult to establish, we need to improve for the better conditions in our emergency center for treatment and initiation base of clinic criteria.

Prognostic value of intraventricular bleeding in spontaneous intraparenchymal cerebral hemorrhage of small volume: a prospective cohort study.

PubMed

Fortes Lima, Telmo Tiburcio; Prandini, Mirto Nelso; Gallo, Pasquale; Cavalheiro, Sérgio

2012-04-01

The literature is controversial on whether intraventricular bleeding has a negative impact on the prognosis of spontaneous intracerebral hemorrhage. Nevertheless, an association between intraventricular bleeding and spontaneous intracerebral hemorrhage volumes has been consistently reported. To evaluate the prognostic value of intraventricular bleeding in deep intraparenchymal hypertensive spontaneous hemorrhage with a bleeding volume <30 cm(3). Of the 320 patients initially evaluated, 33 met the inclusion criteria and were enrolled in this prospective study. The volume of intraparenchymal hemorrhage was calculated by brain computed tomography (CT) image analysis, and the volume of intraventricular bleeding was calculated by the LeRoux scale. Clinical data, including neurological complications, were collected daily during hospitalization. Neurological outcome was evaluated 30 days after the event by using the Glasgow outcome scale. Patients were assigned to 1 of 3 groups according to intraventricular bleeding: Control, no intraventricular bleeding; LR 1, intraventricular bleeding with LeRoux scale scores of 1 to 8; or LR 2, intraventricular bleeding with LeRoux scale scores >8. There were no significant differences among groups concerning age, mean blood pressure, and time from onset to brain CT scan. Patients with greater intraventricular bleeding presented lower initial Glasgow coma scale scores, increased ventricular index and width of temporal horns, increased number of clinical and neurological complications, and longer hospitalization. Furthermore, their relative risk for unfavorable clinical outcome was 1.9 (95% confidence interval 1.25-2.49). Intraventricular bleeding with a LeRoux scale score >8 appears to have a negative effect on deep spontaneous intraparenchymal cerebral hemorrhage of small volume.

Tamoxifen treatment of bleeding irregularities associated with Norplant use.

PubMed

Abdel-Aleem, Hany; Shaaban, Omar M; Amin, Ahmed F; Abdel-Aleem, Aly M

2005-12-01

To evaluate the possible role of tamoxifen (selective estrogen receptor modulators, SERM) in treating bleeding irregularities associated with Norplant contraceptive use. Randomized clinical trial including 100 Norplant users complaining of vaginal bleeding irregularities. The trial was conducted in the Family Planning Clinic of Assiut University Hospital. Women were assigned at random to receive tamoxifen tablets (10 mg) twice daily for 10 days or similar placebo. Women were followed-up for 3 months. The end points were percentage of women who stopped bleeding during treatment, bleeding/spotting days during the period of follow-up, effect of treatment on their lifestyle, and side effects and discontinuation of contraception. There was good compliance with treatment. At the end of treatment, a significantly higher percentage of tamoxifen users stopped bleeding in comparison to the control group (88% vs. 68%, respectively; p=.016). Women who used tamoxifen had significantly less bleeding and/or spotting days than women who used placebo, during the first and second months. During the third month, there were no significant differences between the two groups. Women who used tamoxifen reported improvement in performing household activities, religious duties and in sexual life, during the first 2 months. In the third month, there were no differences between the two groups. There were no significant differences between tamoxifen and placebo groups in reporting side effects. In the group who used tamoxifen, two women discontinued Norplant use because of bleeding vs. nine women in the placebo group. Tamoxifen use at a dose of 10 mg twice daily orally, for 10 days, has a beneficial effect on vaginal bleeding associated with Norplant use. In addition, the bleeding pattern was better in women who used tamoxifen for the following 2 months after treatment. However, these results have to be confirmed in a larger trial before advocating this line of treatment.

Routine perioperative ketorolac administration is not associated with hemorrhage in pediatric neurosurgery patients.

PubMed

Richardson, Marlin Dustin; Palmeri, Nicholas O; Williams, Sarah A; Torok, Michelle R; O'Neill, Brent R; Handler, Michael H; Hankinson, Todd C

2016-01-01

OBJECT NSAIDs are effective perioperative analgesics. Many surgeons are reluctant to use NSAIDs perioperatively because of a theoretical increase in the risk for bleeding events. The authors assessed the effect of routine perioperative ketorolac use on intracranial hemorrhage in children undergoing a wide range of neurosurgical procedures. METHODS A retrospective single-institution analysis of 1451 neurosurgical cases was performed. Data included demographics, type of surgery, and perioperative ketorolac use. Outcomes included bleeding events requiring return to the operating room, bleeding seen on postoperative imaging, and the development of renal failure or gastrointestinal tract injury. Variables associated with both the exposure and outcomes (p < 0.20) were evaluated as potential confounders for bleeding on postoperative imaging, and multivariable logistic regression was performed. Bivariable analysis was performed for bleeding events. Odds ratios and 95% CIs were estimated. RESULTS Of the 1451 patients, 955 received ketorolac. Multivariate regression analysis demonstrated no significant association between clinically significant bleeding events (OR 0.69; 95% CI 0.15-3.1) or radiographic hemorrhage (OR 0.81; 95% CI 0.43-1.51) and the perioperative administration of ketorolac. Treatment with a medication that creates a known bleeding risk (OR 3.11; 95% CI 1.01-9.57), surgical procedure (OR 2.35; 95% CI 1.11-4.94), and craniotomy/craniectomy (OR 2.43; 95% CI 1.19-4.94) were associated with a significantly elevated risk for radiographically identified hemorrhage. CONCLUSIONS Short-term ketorolac therapy does not appear to be associated with a statistically significant increase in the risk of bleeding documented on postoperative imaging in pediatric neurosurgical patients and may be considered as part of a perioperative analgesic regimen. Although no association was found between ketorolac and clinically significant bleeding events, a larger study needs to be conducted to control for confounding factors, because of the rarity of these events.

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding.

PubMed

Shah, Keyur B; Gunda, Sampath; Emani, Sitaramesh; Kanwar, Manreet K; Uriel, Nir; Colombo, Paolo C; Uber, Patricia A; Sears, Melissa L; Chuang, Joyce; Farrar, David J; Brophy, Donald F; Smallfield, George B

2017-11-01

Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P =0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P =0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P =0.04). Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. © 2017 American Heart Association, Inc.

Recurrent haematomas of the thigh: a case of von Willebrand's disease presenting to a sports clinic

PubMed Central

Owens, S.; Baglin, T.

2000-01-01

Von Willebrand's disease is a relatively common mild form of haemophilia. It should be suspected in assessing sports injuries when excessive bleeding occurs in response to relatively mild trauma. Those with the disease should remain active but avoid contact sports. They should not take aspirin or non-steroidal anti-inflammatory drugs, which may exacerbate bleeding, and should be given supportive treatment to cover dental extraction, surgery, or significant bleeding episodes. Key Words: von Willebrand's disease; haemophilia; haematoma; sports clinic PMID:10786868

Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review.

PubMed

Zhang, Jiaxing; Liang, Yi; Ai, Yuan; Xie, Juan; Li, Youping; Zheng, Wenyi

2017-10-01

We conducted a systematic review to assess the efficacy and safety of Thrombopoietin-receptor agonists (TPOras) for pediatric immune thrombocytopenia (ITP). We searched PubMed, Embase and Cochrane Library from their earliest records to January 2017. Randomized controlled trials (RCTs) were included. Primary outcomes were durable response and clinically significant bleeding. Secondary outcomes were overall response, overall bleeding events, the use of rescue medication and adverse events (AEs). Five randomized RCTs (261participants) were included. Compared with placebo group, the proportion of patients achieving durable platelet response was significantly higher in Eltrombopag (P = 0.0004) or Romiplostim (P = 0.002) group, so was the overall response in Eltrombopag [RR = 2.64, 95% CI (1.58, 4.44)] or Romiplostim [RR = 5.05, 95% CI (2.21, 11.53)] group. Both clinically significant bleeding (P = 0.04) and total bleeding (P = 0.01) in Eltrombopag group were significantly less frequent than those in placebo group, while no significant difference between Romiplostim and placebo group. The proportion of patients receiving rescue medication, the incidence of overall AEs and serious AEs between TPO-receptor agonists and placebo group were not significantly different. TPOras might improve both durable and overall platelet response in pediatric ITP, compared with placebo.

Efficacy and toxicity of Samen-ista emulsion on treatment of cutaneous and mucosal bleeding.

PubMed

Hosseini, Mousalreza; Pourakbar, Ali; Forouzanfar, Fatemeh; Arian, Amirali; Ghaffarzadegan, Kamran; Salehi, Maryam; Esfandiari, Samaneh; Rakhshandeh, Hassan

2016-10-01

Despite new treatment methods, upper gastrointestinal bleeding remains challenging. Samen-ista emulsion is a new agent based on traditional medicine with coagulant properties. The efficacy and safety of Samen-ista were assessed in cutaneous and mucosal bleeding animal models. Coagulant properties of Samen-ista were evaluated using mice tail bleeding assay, marginal ear vein and upper gastrointestinal mucosal bleeding times in rabbits. After 7 days, clinical signs, mortality and end-organ (kidney, liver, lung, brain and gastric mucosa) histopathological changes were also examined. Samen-ista dose-dependently decreased mean cutaneous tail (128 vs. 14 s) and marginal ear vein (396 vs. 84 s) bleeding times. Rabbit's upper gastrointestinal bleeding time was also significantly decreased (214 vs. 15.8 s) upon Samen-ista local endoscopic application. Treatment with Samen-ista for 7 days did not cause any mortality, abnormal signs of bleeding, changes in appetite or significant histopathologicl changes. Samen-ista emulsion is well tolerated and highly effective in achieving hemostasis in cutaneous and mucosal bleeding animal models.

Superselective Embolization for Arterial Upper Gastrointestinal Bleeding Using N-Butyl Cyanoacrylate: A Single-Center Experience in 152 Patients.

PubMed

Hur, Saebeom; Jae, Hwan Jun; Lee, Hyukjoon; Lee, Myungsu; Kim, Hyo-Cheol; Chung, Jin Wook

2017-12-01

To evaluate 30-day safety and efficacy of superselective embolization for arterial upper gastrointestinal bleeding (UGIB) using N-butyl cyanoacrylate (NBCA). This single-center retrospective 10-year study included 152 consecutive patients with UGIB (gastric, n = 74; duodenal, n = 78) who underwent embolization with NBCA for angiographically positive arterial bleeding. The primary endpoint was clinical success rate defined as achievement of hemostasis without rebleeding or UGIB-related mortality within 30 days after embolization. Mean systolic blood pressure and heart rate were 121.2 mm Hg ± 27.4 and 97.9 beats/minute ± 22.5; 31.1% of patients needed intravenous inotropes, and 36.6% had coagulopathy. The etiology of bleeding was ulcer (80.3%) or iatrogenic injury (19.7%). Statistical analysis was performed to identify predictive factors for outcomes. Technical success rate was 100%. Clinical success, 1-month mortality, and major complication rates were 70.4%, 22.4%, and 0.7%. There were significant differences in the clinical success rates between gastric and duodenal bleeding (79.4% vs 62.2%; P = .025). The need for intravenous inotropes at the time of embolization was a significant negative predictive factor in both gastric (odds ratio [OR] = 0.091, P = .004) and duodenal (OR = 0.156, P = .002) bleeding. The use of a microcatheter with a smaller tip (2 F) was associated with better outcomes in duodenal bleeding (OR = 7.389, P = .005). Superselective embolization using NBCA is safe and effective for angiographically positive arterial UGIB. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Management of gastrointestinal bleeding in patients anticoagulated with dabigatran compared with warfarin: a retrospective, comparative case review.

PubMed

Manatsathit, Wuttiporn; Al-Hamid, Hussein; Leelasinjaroen, Pornchai; Hashmi, Usman; McCullough, Peter A

2014-06-01

Dabigatran etexilate, was found to be effective for stroke prevention in patients with non-valvular atrial fibrillation. Given its predictable pharmacodynamics, laboratory monitoring is not required. Moreover, the risks of overall bleeding, intracranial bleeding, and life-threatening hemorrhage from dabigatran were found to be lower than warfarin. However, a higher risk of gastrointestinal (GI) bleeding caused by dabigatran from the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial has raised the concern regarding clinical outcomes of patients with GI bleeding caused by dabigatran compared with warfarin. We retrospectively studied patients who were hospitalized for GI bleeding from dabigatran compared with warfarin with therapeutic anticoagulation monitoring during 2009 to 2012. Initial laboratory findings at presentation, number of transfused packed red blood cells (PRBCs), acute kidney injury, clinical outcomes (e.g., hypotension, tachycardia), length of stay, and death were compared. Thirteen patients taking dabigatran and 26 patients who were on warfarin with therapeutic international normalized ratio (INR) were hospitalized during the study period. Demographic data and baseline parameters between the two groups were not significantly different except for concurrent aspirin use (84.6% vs. 50%, P=0.036). Fifty-four percent of patients taking dabigatran did not have activated partial thromboplastin time (aPTT) level performed at presentation (7/13). The patients with GI bleeding from warfarin received significantly more PRBC transfusions compared with the dabigatran group (1.92±2.2 vs. 0.69±1.1 units, P=0.024). After controlling for initial hemoglobin and history of chronic kidney disease by using multivariate analysis, the patients in the warfarin group were likely to receive more PRBC. Hypotension at presentation was more common in GI bleeding caused by warfarin than dabigatran but the P value was insignificant (30.8% vs. 7.7%, P=0.11). Nevertheless, no differences in clinical outcomes or length of stay were found between the two groups. From our data, the patients with GI bleeding from dabigatran were likely to receive fewer PRBC transfusions; however, clinical outcomes and length of stay were comparable to GI bleeding caused by warfarin. Our sample generalizes to an elderly population (mean age of 77.9±10 years old) with creatinine clearance (CrCl) >30 mL/min who experience GI bleeding during chronic anticoagulation.

Practical management of bleeding in patients receiving non-vitamin K antagonist oral anticoagulants.

PubMed

Weitz, Jeffrey I; Pollack, Charles V

2015-11-25

Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly used in the prevention and treatment of venous thromboembolism and in the prevention of stroke in patients with non-valvular atrial fibrillation. In phase III clinical trials and meta-analyses, the NOACs were at least as effective as vitamin K antagonists (VKAs) and were associated with a similar or lower incidence of major bleeding, including consistent and significant decreases in intracranial bleeding, although with an increase in gastrointestinal bleeding for some agents compared with VKAs. Subsequent real-world evidence supports these outcomes. Despite this, physicians have concerns about serious bleeding or emergencies because there are no specific reversal agents for the NOACs. However, in clinical trials, patients receiving NOACs generally had similar or better outcomes after these events than those taking VKAs. As with any bleeding, anticoagulant-related bleeding should first be stratified according to severity and location; risk can be minimised by ongoing assessment. Management protocols for NOAC-related bleeding are similar to those for VKAs but should take into account the pharmacological profile of the specific drug. Because of their short half-lives, NOAC-related mild bleeding can often be controlled by temporarily withholding treatment. More severe bleeding requires standard escalating haemodynamic support measures, and non-specific reversal agents can be considered in life-threatening situations, based on limited clinical data. Specific and rapid reversal agents are not currently available for any oral anticoagulant and restoration of coagulation may not necessarily lead to better outcomes. Nevertheless, specific NOAC reversal agents are in development and show promise in healthy volunteers.

Effects of a triclosan dentifrice on plaque formation, gingivitis and gingival bleeding in pregnant women: five-month clinical results.

PubMed

Kraivaphan, P; Amornchat, C; Triratana, T

2007-05-01

The objective of this study was to determine the effects of a triclosan/copolymer dentifrice on plaque formation, gingivitis and gingival bleeding in pregnant subjects. This double-blind clinical study was carried out in 180 women at 3 months of pregnancy. The subjects were stratified into two balanced groups according to their baseline plaque, gingivitis and bleeding scores. Subjects received a thorough dental prophylaxis and were assigned to brush with either a placebo or triclosan dentifrice for five months. They were instructed to brush their teeth as they normally would, twice a day for one minute per brushing. Follow-up examinations after five months of dentifrice use evaluated supragingival plaque, gingivitis and gingival bleeding. After five months, the triclosan dentifrice significantly reduced plaque formation, gingivitis and gingival bleeding by 40.5%, 22.5% and 35.3%, respectively, compared to the placebo group (p<0.05).

One-year clinical results of Er,Cr:YSGG laser application in addition to scaling and root planing in patients with early to moderate periodontitis.

PubMed

Kelbauskiene, Solveiga; Baseviciene, Nomeda; Goharkhay, Kawe; Moritz, Andreas; Machiulskiene, Vita

2011-07-01

In 30 patients with periodontitis, a total of 278 teeth exhibiting bleeding on probing, subgingival calculus, and a probing depth between 3-6 mm were examined. For each participant, two treatment types were alternatively applied on the contralateral quadrants: scaling and root planing (SRP) as control, and SRP followed by Er,Cr:YSGG laser application (SRP+laser), as a test method. Five clinical parameters: plaque level, bleeding on probing, probing depth, gingival recession and clinical attachment level were examined at baseline and at 2, 3, 6, 12 months after treatment. Of the total of 1,668 sites examined in all patients, 1,088 sites were found with a probing depth of 3-6 mm. In these sites, differences in clinical parameters between SRP and SRP+laser-treated quadrants were analyzed, assuming the level of p < 0.05 as significant. After 2 months from baseline, the mean probing depth reduction and the clinical attachment level gain were significantly greater in SRP+laser than in SRP quadrants, and remained so throughout the study (p < 0.001). A marked reduction of the bleeding scores occurred in all examined sites, irrespective of the treatment method. However, after 12 months, significantly less teeth exhibited bleeding on probing in SRP+laser quadrants than in SRP quadrants (p < 0.001). The mean plaque and gingival recession levels did not differ between the SRP and SRP+laser quadrants neither before nor after the treatment. The periodontal procedures either using Er,Cr:YSGG laser after SRP or SRP alone, lead to significant improvements in all clinical parameters investigated. However, laser application, as an adjunct to SRP, appeared to be more advantageous.

Rectal bleeding, fecal incontinence, and high stool frequency after conformal radiotherapy for prostate cancer: Normal tissue complication probability modeling

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peeters, Stephanie; Hoogeman, Mischa S.; Heemsbergen, Wilma D.

2006-09-01

Purpose: To analyze whether inclusion of predisposing clinical features in the Lyman-Kutcher-Burman (LKB) normal tissue complication probability (NTCP) model improves the estimation of late gastrointestinal toxicity. Methods and Materials: This study includes 468 prostate cancer patients participating in a randomized trial comparing 68 with 78 Gy. We fitted the probability of developing late toxicity within 3 years (rectal bleeding, high stool frequency, and fecal incontinence) with the original, and a modified LKB model, in which a clinical feature (e.g., history of abdominal surgery) was taken into account by fitting subset specific TD50s. The ratio of these TD50s is the dose-modifyingmore » factor for that clinical feature. Dose distributions of anorectal (bleeding and frequency) and anal wall (fecal incontinence) were used. Results: The modified LKB model gave significantly better fits than the original LKB model. Patients with a history of abdominal surgery had a lower tolerance to radiation than did patients without previous surgery, with a dose-modifying factor of 1.1 for bleeding and of 2.5 for fecal incontinence. The dose-response curve for bleeding was approximately two times steeper than that for frequency and three times steeper than that for fecal incontinence. Conclusions: Inclusion of predisposing clinical features significantly improved the estimation of the NTCP. For patients with a history of abdominal surgery, more severe dose constraints should therefore be used during treatment plan optimization.« less

Aminocaproic acid for the management of bleeding in patients on extracorporeal membrane oxygenation: Four adult case reports and a review of the literature.

PubMed

Buckley, Leo F; Reardon, David P; Camp, Phillip C; Weinhouse, Gerald L; Silver, David A; Couper, Gregory S; Connors, Jean M

2016-01-01

Extracorporeal membrane oxygenation (ECMO) is associated with a significant risk of bleeding and thrombosis. Despite high rates of bleeding and bleeding-related mortality in patients on ECMO, there is little evidence available to guide clinicians in the management of ECMO-associated bleeding. We report the use of aminocaproic acid in four patients with bleeding on ECMO and a review of the literature. High D-dimer levels and low fibrinogen levels suggested that an antifibrinolytic agent may be effective as an adjunct to control bleeding. After aminocaproic acid administration, bleeding was controlled in each patient as evidenced by clinical and laboratory parameters. One patient suffered a cardiac arrest and care was withdrawn. In patients on ECMO with evidence of fibrinolysis, aminocaproic acid may be an effective option to control bleeding and to stabilize clot formation. Copyright © 2016 Elsevier Inc. All rights reserved.

Physical activity and risk of bleeding in elderly patients taking anticoagulants.

PubMed

Frey, P M; Méan, M; Limacher, A; Jaeger, K; Beer, H-J; Frauchiger, B; Aschwanden, M; Rodondi, N; Righini, M; Egloff, M; Osterwalder, J; Kucher, N; Angelillo-Scherrer, A; Husmann, M; Banyai, M; Matter, C M; Aujesky, D

2015-02-01

Although the possibility of bleeding during anticoagulant treatment may limit patients from taking part in physical activity, the association between physical activity and anticoagulation-related bleeding is uncertain. To determine whether physical activity is associated with bleeding in elderly patients taking anticoagulants. In a prospective multicenter cohort study of 988 patients aged ≥ 65 years receiving anticoagulants for venous thromboembolism, we assessed patients' self-reported physical activity level. The primary outcome was the time to a first major bleeding, defined as fatal bleeding, symptomatic bleeding in a critical site, or bleeding causing a fall in hemoglobin or leading to transfusions. The secondary outcome was the time to a first clinically relevant non-major bleeding. We examined the association between physical activity level and time to a first bleeding by using competing risk regression, accounting for death as a competing event. We adjusted for known bleeding risk factors and anticoagulation as a time-varying covariate. During a mean follow-up of 22 months, patients with a low, moderate, and high physical activity level had an incidence of major bleeding of 11.6, 6.3, and 3.1 events per 100 patient-years and an incidence of clinically relevant non-major bleeding of 14.0, 10.3, and 7.7 events per 100 patient-years, respectively. A high physical activity level was significantly associated with a lower risk of major bleeding (adjusted sub-hazard ratio 0.40, 95% confidence interval 0.22-0.72). There was no association between physical activity and non-major bleeding. A high level of physical activity is associated with a decreased risk of major bleeding in elderly patients receiving anticoagulant therapy. © 2014 International Society on Thrombosis and Haemostasis.

Role of transcatheter arterial embolization for massive bleeding from gastroduodenal ulcers

PubMed Central

Loffroy, Romaric; Guiu, Boris

2009-01-01

Intractable bleeding from gastric and duodenal ulcers is associated with significant morbidity and mortality. Aggressive treatment with early endoscopic hemostasis is essential for a favourable outcome. In as many as 12%-17% of patients, endoscopy is either not available or unsuccessful. Endovascular therapy with selective catheterization of the culprit vessel and injection of embolic material has emerged as an alternative to emergent operative intervention in high-risk patients. There has not been a systematic literature review to assess the role for embolotherapy in the treatment of acute upper gastrointestinal bleeding from gastroduodenal ulcers after failed endoscopic hemostasis. Here, we present an overview of indications, techniques, and clinical outcomes after endovascular embolization of acute peptic-ulcer bleeding. Topics of particular relevance to technical and clinical success are also discussed. Our review shows that transcatheter arterial embolization is a safe alternative to surgery for massive gastroduodenal bleeding that is refractory to endoscopic treatment, can be performed with high technical and clinical success rates, and should be considered the salvage treatment of choice in patients at high surgical risk. PMID:20014452

Preoperative Mechanical Bowel Evacuation Reduces Intraoperative Bleeding and Operation Time in Spinal Surgery.

PubMed

Rezvani, Majid; Abbasi, Reza; Tabesh, Homayoon; Dehghani, Leila; Dolatkhah, Shahab; Nasri, Maryam; Kolahdouzan, Mohsen; Meamar, Rokhsareh

2018-06-01

Randomized clinical trial. In this study, we evaluated the effect of mechanical evacuation of the bowels prior to operation on intraoperative bleeding. Bleeding is the most significant complication in patients undergoing spinal surgery. We randomly divided 108 individuals planned to undergo spinal surgery into two age-, sex-, and co-morbidity (especially preoperative hemoglobin [Hb])-matched groups of 54. The treatment group was administered polyethylene glycol (PEG) before the operation, whereas the control group was not. The exact amount (mL) of bleeding during operation, operative time, and approximate amount of blood transfused were recorded. The volume of bleeding and Hb level were also recorded 24 and 48 hours postoperatively. T -tests revealed that intraoperative bleeding, the volume of transfusion, and operative time were significantly lower in the treatment group than in the control group. Statistically significant correlations of intraoperative bleeding with age, body mass index (BMI), preoperative Hb levels, operative time, the volume of transfusion, hospitalization time, and 24- and 48-hour postoperative bleeding were observed ( p =0.001, all). Repeated measures analysis of covariance after adjusting the covariate variables revealed that the volume of bleeding showed a near-significant trend in the treatment group compared with that in the control group ( p =0.056). Diabetic females had the highest bleeding amount between the groups ( p =0.03). Bleeding was higher in patients with higher BMI ( p =0.02) and was related to operative time ( p =0.001) in both the groups. Preoperative gastrointestinal tract evacuation by PEG administration can decrease intraoperative bleeding in spinal surgeries; however, more research is imperative regarding PEG administration in surgical procedures for this purpose.

[Effect of short-acting combined oral contraceptives on bleeding after induced abortion].

PubMed

Wang, X F; Zhong, M; Liu, J

2017-11-07

Objective: To explore the effect of short-acting combined oral contraceptives on vaginal bleeding after induced abortion. Methods: A total of 726 patients, who had took induced abortion from July 2016 to September 2016 in obstetrics and gynecology outpatient department of Nanfang Hospital, Southern Medical University, were included and divided into the observation group and the control group according to whether they took short-acting combined oral contraceptives after induced abortion, with 312 cases, 414 cases respectively.The vaginal bleeding days, amounts of bleeding, the endometrial thickness 3 weeks later, and whether the patient had menstrual recovery on time were observed and analyzed. Results: The observation group had less bleeding days and amount of bleeding, compared with the control group.69.87% (218/312) patients of the observation group had more than 8mm of endometrial thickness on postoperative day 21, while 61.11% (253/414) of the observation group did, the difference was statistically significant ( P =0.034).90.06% (281/312) patients of the observation group had menstrual recovery on time, while 82.61% (342/414) of the observation group did, the difference was statistically significant ( P =0.004). Conclusion: Short-acting combined oral contraceptives after induced abortion can significantly shorten the vaginal bleeding days, reduce the amount of bleeding, promote endometrial repair and menstrual recovery.There fore, it has important clinical significance and application value.

Assessing Abnormal Uterine Bleeding: Are Physicians Taking a Meaningful Clinical History?

PubMed

Lam, Christina; Anderson, Britta; Lopes, Vrishali; Schulkin, Jay; Matteson, Kristen

2017-07-01

Women with abnormal uterine bleeding (AUB) report significant reductions in quality of life (QOL), which can be attributed in many cases to the fear of embarrassing episodes of bleeding. We performed this study to determine whether or not during clinical encounters physicians addressed the impact of AUB on patient-reported QOL. Between October 2008 and May 2009, we conducted a cross-sectional study of members of the American College of Obstetricians and Gynecologists. Surveys were distributed using a mixed method (web- and mail-based) and included questions about physician characteristics and types of questions used when obtaining a clinical history from a patient with AUB. We calculated the proportion of physicians who endorsed asking each type of clinical question with 95% confidence intervals (CIs). Four hundred seventeen questionnaires were returned (52%). Ninety-nine percent (95% CI 98.4%-99.9%) reported always asking a bleeding heaviness question, 87.2% (95% CI 83.2%-90.5%) reported always asking a QOL question, and 17.5% (95% CI 13.6%-21.9%) reported always asking a mood associated with bleeding question. Seventy-eight percent specifically asked patients about bleeding through their clothes, and 55% asked about changing social plans because of bleeding. Only 18% endorsed that asking about QOL was most essential for the evaluation of women with AUB. No physician characteristics such as years since completing residency, geography, or gender were associated with how commonly providers reported asking questions regarding impact of bleeding on QOL. Physicians may not be optimizing patient-provider interactions during menstrual history taking with patients with AUB by failing to assess impact of AUB on QOL in a way that is meaningful to patients.

Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial.

PubMed

Kilic, Sinem; Van't Hof, Arnoud W J; Ten Berg, Jurrien; Lopez, Ana Ayesta; Zeymer, Uwe; Hamon, Martial; Soulat, Louis; Bernstein, Debra; Deliargyris, Efthymios N; Steg, Phillippe Gabriel

2016-05-15

The overall impact of post percutaneous coronary intervention (PCI) bleeding on long term prognosis after acute coronary syndromes (ACS) has been established, but it may differ between access and non-access related bleeding events. The impact of antithrombin choice on bleeding may also differ according to the origin of the bleed. We sought to determine the origin of bleeding relative to the access site, its prognostic significance and the respective impact of antithrombin therapy in the EUROMAX trial. We performed a blinded review of the case records of all TIMI major or minor bleeds in the EUROMAX trial and assigned them in one of 2 categories: access site bleeds (ASB), or rest of bleeds (ROB). Incidence of bleeding for each category was assessed according to randomization to antithrombotic treatment. A total of 231 out of 2198 patients suffered a TIMI major/minor bleed (10.5%) and ASB accounted for 48.5%, while ROB for 51.5% of the bleeds. Thirty day mortality was 2.5% (50/1967) for patients without a bleed, 2.7% (3/112, p=0.76 vs. no bleed) for patients with ASB, and 10.9% (13/119, p<0.0001 vs. no bleed) for ROB patients. The use of bivalirudin reduced both ASB and ROB with relative risk reductions of 34% and 46% respectively. In contemporary primary PCI, bleeding originates with equal frequency either at or away from the access site. Access site bleeds were not associated with an excess in 30day mortality, but the rest of the bleeds were. Bivalirudin is associated with a lower risk of bleeding irrespective of origin. ClinicalTrials.gov identifier NCT01087723. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

An observational European study on clinical outcomes associated with current management strategies for non-variceal upper gastrointestinal bleeding (ENERGIB-Turkey).

PubMed

Mungan, Zeynel

2012-01-01

This observational, retrospective cohort study assessed outcomes of the current management strategies for nonvariceal upper gastrointestinal bleeding in several European countries (Belgium, Greece, Italy, Norway, Portugal, Spain, and Turkey) (NCT00797641; ENERGIB). Turkey contributed 23 sites to this study. Adult patients (≥18 years old) consecutively admitted to hospital and who underwent endoscopy for overt non-variceal upper gastrointestinal bleeding (hematemesis, melena or hematochezia, with other clinical/laboratory evidence of acute upper GI blood loss) were included in the study. Data were collected from patient medical records regarding bleeding continuation, re-bleeding, pharmacological treatment, surgery, and mortality during a 30-day follow-up period. A total of 423 patients (67.4% men; mean age: 57.8 ± 18.9 years) were enrolled in the Turkish study centers, of whom 96.2% were admitted to hospital with acute non-variceal upper gastrointestinal bleeding. At admission, the most common symptom was melena (76.1%); 28.6% of patients were taking aspirin, 19.9% were on non-steroidal anti-inflammatory drugs, and 7.3% were on proton pump inhibitors. The most common diagnoses were duodenal (45.2%) and gastric (27.7%) ulcers and gastritis/gastric erosions (26.2%). Patients were most often managed in general medical wards (45.4%). A gastrointestinal team was in charge of treatment in 64.8% of cases. Therapeutic procedures were performed in 32.4% of patients during endoscopy. After the endoscopy, most patients (94.6%) received proton pump inhibitors. Mean (SD) hospital stay was 5.36 ± 4.91 days. The cumulative proportions of continued bleeding/re-bleeding, complications and mortality within 30 days of the non-variceal upper gastrointestinal bleeding episode were 9.0%, 5.7% and 2.8%, respectively. In the Turkish sub-group of patients, the significant risk factors for bleeding continuation or re-bleeding were age >65 years, presentation with hematemesis or shock/syncope, and the diagnosis of duodenal ulcer. The risk of clinical complications after non-variceal upper gastrointestinal bleeding was higher in female patients older than 65 years, in patients with comorbidities, and in patients presenting with shock/syncope, and also according to time to endoscopy. The use of aspirin, non-steroidal anti-inflammatory drugs or warfarin at baseline was negatively associated with the development of bleeding or clinical complications. The risk of death within 30 days after non-variceal upper gastrointestinal bleeding was significantly higher in patients older than 65 years and in those receiving transfusions other than intravenous fluid or red blood cells within 12 hours of presentation. According to the survey results, non-variceal upper gastrointestinal bleeding in Turkey varies from that in other European countries in a number of aspects. These differences could be associated with a younger population and Helicobacter pylori incidence. Despite the diminishing need for surgical intervention and mortality rates for non-variceal upper gastrointestinal bleeding, as is the case in other European countries, non-variceal upper gastrointestinal bleeding remains a serious problem.

THROMBIN GENERATION AND BLEEDING IN HEMOPHILIA A

PubMed Central

Brummel-Ziedins, Kathleen E.; Whelihan, Matthew F.; Gissel, Matthew; Mann, Kenneth G.; Rivard, Georges E.

2012-01-01

Introduction Hemophilia A displays phenotypic heterogeneity with respect to clinical severity. Aim To determine if tissue factor (TF)-initiated thrombin generation profiles in whole blood in the presence of corn trypsin inhibitor (CTI) are predictive of bleeding risk in hemophilia A. Methods We studied factor(F) VIII deficient individuals (11 mild, 4 moderate and 12 severe) with a well-characterized five-year bleeding history that included hemarthrosis, soft tissue hematoma and annual FVIII concentrate usage. This clinical information was used to generate a bleeding score. The bleeding scores (range 0–32) were separated into three groups (bleeding score groupings: 0, 0 and ≤9.6, >9.6), with the higher bleeding tendency having a higher score. Whole blood collected by phlebotomy and contact pathway suppressed by 100μg/mL CTI was stimulated to react by the addition of 5pM TF. Reactions were quenched at 20min by inhibitors. Thrombin generation, determined by ELISA for thrombin – antithrombin was evaluated in terms of clot time (CT), maximum level (MaxL) and maximum rate (MaxR) and compared to the bleeding score. Results Data are shown as the mean±SD. MaxL was significantly different (p<0.001) between the groups: 504±114nM, 315±117nM, and 194±91nM; with higher thrombin concentrations in the groups with lower bleeding scores. MaxR was higher in the groups with a lower bleeding score; 97±51nM/min, 86±60nM/min and 39±16nM/min (p=0.09). No significant difference was detected in CT among the groups, 5.6±1.3min, 4.7±0.7min, 5.6±1.3min. Conclusions Our empirical study in CTI-inhibited whole blood shows that the MaxL of thrombin generation appears to correlate with the bleeding phenotype of hemophilia A. PMID:19563500

Use of Contraindicated Antiplatelet Medications in the Setting of Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

PubMed

Barnes, Geoffrey D; Stanislawski, Maggie A; Liu, Wenhui; Barón, Anna E; Armstrong, Ehrin J; Ho, P Michael; Klein, Andrew; Maddox, Thomas M; Nallamothu, Brahmajee K; Rumsfeld, John S; Tsai, Thomas T; Bradley, Steven M

2016-07-01

Several antiplatelet medications used during and after percutaneous coronary intervention (PCI) are contraindicated for specific patient groups. A broad assessment of contraindicated medication use and associated clinical outcomes is not well described. Using national Veterans Affairs Clinical Assessment, Reporting, and Tracking Program data for all PCI between 2007 and 2013, we evaluated patients with contraindications to commonly used antiplatelet medications during and after PCI, defined in accordance with package inserts. Adjusted association between contraindicated medication use and outcomes of periprocedural bleeding and 30-day mortality were assessed using Cox proportional hazards with inverse probability weighting. Among 64 294 patients undergoing PCI, 11 315(17.6%) had a contraindication to a common antiplatelet medication and 737 (6.5%) of these patients received a contraindicated medication. In unadjusted analyses, any contraindicated medication use was associated with both increased bleeding and 30-day mortality. In adjusted models, contraindicated abciximab use in patients with thrombocytopenia (hazard ratio, 2.23; 95% confidence interval, 1.58-3.16) and in patients with a previous stroke (hazard ratio, 1.93; 95% confidence interval, 1.37-2.71) remained significantly associated with increased bleeding. Contraindicated abciximab use was not significantly associated with 30-day mortality in adjusted models. Use of eptifibatide in dialysis patients was not significantly associated with an increased risk of bleeding or mortality. In this national cohort, ≈18% of patients undergoing PCI had contraindications to common antiplatelet medications. Approximately 6% of those patients received a contraindicated medication with attendant bleeding risk, although this did not translate into significantly higher risk of 30-day mortality. Continued efforts to reduce contraindicated medication use may help avoid periprocedural complications. © 2016 American Heart Association, Inc.

[Research of gestrinone-related abnormal uterine bleeding and the intervention in the treatment: a multi-center, randomized, controlled clinical trial].

PubMed

Duan, H; Wang, S; Hao, M; Chen, L; Tang, J; Wang, X; Peng, Y Z; Zhang, S C; Cao, L R; Yu, J J

2016-02-01

To investigate the incidence, influencing factors and intervention of gestrinone-related abnormal uterine bleeding at different dosage of gestrinone in the clinical treatment. This was a multicenter, randomized, control study of 195 Chinese women with endometriosis or adenomyosis from June 2011 to November 2013. The subjects were randomized into three groups with oral administration of gestrinone, 2.5 mg dose at one time; twice a week group: 67 cases with oral administration twice a week last three months; double dose first month group: 67 cases with oral administration triple times a week at first month, then twice a week for two months; three times a week group: 61 cases with oral administration three times a week last three months. The improvement of the abnormal uterine bleeding, the changes in estrogen, liver function and blood coagulation were evaluated. At the same time, B-ultrasound examination evaluation were performed. (1) Three months later, the incidence of abnormal uterine bleeding in twice a week group was 30% (20/67), in double dose first month group and three times a week group were 7%(5/67) and 16% (10/61) respectively, there were significant difference between three groups (P<0.05). The incidence in double dose first month group was the most lower. (2) Univariate analysis showed that the dosage and ovarian size were the significant factors for abnormal uterine bleeding (OR=0.461,P= 0.003;OR=0.303,P=0.016); logistic regression analysis demonstrated that the risk of abnormal uterine bleeding in double dose first month group was the lowest when compared with twice a week group and three times a week group, the risk in twice a week group was 5-fold higher than that in double dose first month group (OR=0.211,P=0.011). The incidence of abnormal uterine bleeding in participants with abnormal ovarian volume results from ovarian cyst or ovarian surgery was significantly lower than those with normal ovarian volume (OR=0.304,P=0.018). (3) After the treatment of three months, there were no significant difference in alanine transaminase level between the groups (P>0.05). The body mass index significantly increased in three group (P<0.05), but there were no significant differences between the groups (P>0.05). As for blood coagulation, there were also no significant differences between the groups (P>0.05). Double dose of gestrinone in the first month could significantly decrease the incidence of gestrinone-related abnormal uterine bleeding. It is a more optimied dosage of gestrinone and without severe side effects. Chinese Clinical Trial Registry, registration number: ChiCTR-TRC-12002327.

Clinical Effects of Stabilized Stannous Fluoride Dentifrice in Reducing Plaque Microbial Virulence I: Microbiological and Receptor Cell Findings.

PubMed

Klukowska, Malgorzata; Haught, John Christian; Xie, Sancai; Circello, Ben; Tansky, Cheryl S; Khambe, Deepa; Huggins, Tom; White, Donald J

2017-06-01

Lipopolysaccharides (LPSs) and lipoteichoic acids (LTAs), or bacterial endotoxins, bind with Toll-like receptors (TLRs) that are expressed on host cells of the periodontium, thereby contributing to the periodontal pathogenicity of oral bacteria. Stannous fluoride (SnF2), an antibacterial fluoride that treats and controls gingivitis, has been shown to react with lipophilic domains/anionic charges in LPS and LTA. The effects of bacterial species and dental plaque on toll receptors can be studied using genetically engineered cell lines containing linked toll receptors on their surfaces. This randomized, examiner-blinded study examined the clinical effects of stabilized SnF2 dentifrice intervention on gingivitis and dental plaque virulence in populations exhibiting high and low levels of clinical gingivitis. Recruited populations were evaluated for gingival inflammation (MGI) and gingival bleeding (GBI) at baseline and assigned into two cohorts of 20 each, those with high (GBI > 20 sites) and low (GBI < 3 sites) levels of observed bleeding/gingivitis. Participants were sampled at baseline for both supra- and subgingival dental plaque at both healthy (no bleeding, PD = 2 mm), as well as clinically diseased sites (bleeding, PD = 3-4 mm), and then provided with an intervention hygiene product including a stabilized SnF2 dentifrice and a new soft bristle manual toothbrush. Following two and four weeks of assigned dentifrice use, participants returned for a re-evaluation of gingival inflammation and bleeding and repeat samplings of dental plaque. Plaque samples were analyzed by anaerobic culturing of gram negative anaerobes (GNA), as well as by incubation of subgingival sampled plaques with TLR4 transfected HEK293 cells, where gene expression was assessed by measurement of a SEAP alkaline phosphatase reporter as a marker of toll receptor activation. Clinical assessments showed statistically significant reductions in MGI (24-26%) and GBI (42-53%) gingivitis in both diseased and healthy cohorts following four weeks of dentifrice intervention. For all clinical examinations, MGI and bleeding sites were statistically significantly different (lower) in the low bleeding versus the higher bleeding cohort. Supragingival and subgingival GNAs were significantly reduced (p < 0.05) in both high and low disease cohorts at bleeding and healthy sites following four weeks of stabilized SnF2 dentifrice use. TLR activation from subgingival sampled plaque was reduced following four weeks of stabilized SnF2 dentifrice use in both high and low disease cohorts and in both healthy, as well as diseased sites. Collectively, these results support the potential for stabilized SnF2 dentifrice to provide clinical gingivitis benefits via mechanisms beyond control of plaque mass, potentially directly decreasing the pathogenicity of plaque biofilms by blocking reactivity of LPS and LTA ligands with tissue receptors associated with inflammation. Importantly, benefits could be seen in both diseased sites, as well as sites not yet exhibiting symptoms of inflammation, supporting the activity of SnF2 not just in treating diseased sites, but in preventing disease development. These learnings may influence treatment planning for patients susceptible to gingivitis.

Safety and efficacy of transcatheter embolization with Glubran®2 cyanoacrylate glue for acute arterial bleeding: a single-center experience with 104 patients.

PubMed

Abdulmalak, Gilles; Chevallier, Olivier; Falvo, Nicolas; Di Marco, Lucy; Bertaut, Aurélie; Moulin, Benjamin; Abi-Khalil, Célina; Gehin, Sophie; Charles, Pierre-Emmanuel; Latournerie, Marianne; Midulla, Marco; Loffroy, Romaric

2018-03-01

To assess the efficacy and the safety of Glubran ® 2 n-butyl cyanoacrylate metacryloxysulfolane (NBCA-MS) transcatheter arterial embolization (TAE) for acute arterial bleeding from varied anatomic sites and to evaluate the predictive factors associated with clinical success and 30-day mortality. A retrospective review of consecutive patients who underwent emergent NBCA-MS Glubran ® 2 TAE between July 2014 and August 2016 was conducted. Variables including age, sex, underlying malignancy, cardiovascular comorbidities, coagulation data, systolic blood pressure, and number of red blood cells units (RBC) transfused before TAE were collected. Clinical success, 30-day mortality, and complication rates were evaluated. Prognostic factors were evaluated by uni- and multivariate logistic regression analyses for clinical success, and by uni- and bivariate analyses after adjustment by bleeding sites for 30-day mortality. 104 patients underwent technically successful embolization with bleeding located in muscles (n = 34, 32.7%), digestive tract (n = 28, 26.9%), and viscera (n = 42, 40.4%). Clinical success rate was 76% (n = 79) and 30-day mortality rate was 21.2% (n = 22). Clinical failure was significantly associated with mortality (p < 0.0001). A number of RBC units transfused greater than or equal to 3 were associated with poorer clinical success (p = 0.025) and higher mortality (p = 0.03). Complications (n = 4, 3.8%) requiring surgery occurred only at puncture site. No ischemic complications requiring further invasive treatment occurred. Mean TAE treatment time was 4.55 min. NBCA-MS Glubran ® 2 TAE is a fast, effective, and safe treatment for acute arterial bleeding whatever the bleeding site.

[Application of TB type thermal balloon endometrial ablation for the treatment of abnormal uterine bleeding].

PubMed

Wang, W; Zhai, Y; Zhang, Z H; Li, Y; Zhang, Z Y

2016-11-08

Objective: To investigate the clinical efficacy, safety and promotion value of TB type thermal balloon endometrial ablation in the treatment of abnormal uterine bleeding. Methods: Fourty three patients who had received TB type endometrial ablation system for treatment of abnormal uterine bleeding from January, 2015 to January, 2016 in theDepartment of gynecology, Beijing Chaoyang Hospital were enrolled in this study. The intra-operative and post-operative complications and improvement of abnormal uterine bleeding and dysmenorrhea were observed. Results: There were nointra-operative complication occurred, such as uterine perforation, massive hemorrhage or surrounding organ damage. At 6 months after operation, 32 patients developed amenorrhea, 6 developed menstrual spotting, 3 developed menstruation with a small volume and 1 had a normal menstruation. No menstruation with an increased volume occurred. The occurrence of amenorrhea was 76.19% and the response rate was 97.62%.At 6 months after operation, 1 case had no response, 2 cases had partial response and 11 cases had complete response among the 14 cases of pre-operative dysmenorrhea; only 3 cases still had anemia among the 23 cases of pre-operative anemia. Compared with before treatment, patients with dysmenorrhea and anemia both significantly reduced with a statistically significant difference( P <0.01). Conclusion: TB type thermal balloon endometrial ablation has a significant efficacy with high safety for the treatment of abnormal uterine bleeding, which could have clinical promotion practice.

The use of a co-design model in improving timely bleed reporting by adults with haemophilia living in the Auckland region of New Zealand.

PubMed

d'Young, A I; Young, L; Ockelford, P A; Brasser, M; Slavin, K; Manson, L; Preston, S

2014-05-01

Many adult patients diagnosed with phenotypically moderate and severe haemophilia living in the Auckland region of New Zealand do not report bleeding episodes within a timeframe that allows for optimal assessment and management. This can result in poor clinical outcomes for patients and poor oversight of the use of expensive clotting factor concentrates. Our goal was to improve both the number and speed at which bleeding episodes were reported to our centre, improving access to care and clinical oversight of the use of expensive factor concentrates and aiding the development of a care partnership with patients. We worked with 70 adult PWH living in the Auckland region of New Zealand with moderate and severe haemophilia A and B. Over a 5-month period between March and July 2013 we used a co-design model to develop and implement a range of strategies to improve the timing and frequency of bleed reporting. Mean bleed reporting time was reduced threefold, with a threefold increase in the number of bleeds reported per month. We reduced the number of bleeding episodes reported outside of a prespecified 48-h time limit by 68%. We significantly improved bleed reporting and time to report, indicating improved access to our services, improved clinical oversight and improved accountability to our national funder. We have achieved a care partnership and a reduction in factor consumption for the study population without compromising the quality of care they receive. © 2013 John Wiley & Sons Ltd.

[Optimal Operational Definition of Patient with Peptic Ulcer Bleeding for Big Data Analysis Using Combination of Clinical Characteristics in a Secondary General Hospital].

PubMed

Lee, Jae Won; Kim, Hyun Ki; Woo, Yong Sik; Jahng, Jaehoon; Jin, Young Ran; Park, Jong Heon; Kim, Yong Sung; Jung, Hwoon Yong

2016-08-25

Peptic ulcer bleeding (PUB) is the most common cause of upper gastrointestinal bleeding in Korea but there has been no research done using big data. This study evaluates the optimal operational definition (OD) for big data research by analyzing clinical characteristics of PUB. We reviewed the clinical characteristics of 92 patients with PUB confirmed on endoscopy in Wonkwang University Sanbon Hospital (January 2013 to December 2014). We calculated sensitivity and positive predictive value (PPV) to detect confirmed PUB patients using ODs developed by combining clinical features of patients with PUB. The mean patient age was 63 years. Men had higher prevalence of PUB than women. Bleeding gastric ulcer was proportionately common in the age range of 40s to 60s in men, while a significantly higher rate of bleeding occurred in women older than 70s. The rate of drug-induced ulcer was 28.2%, whereas the prevalence of Helicobacter pylori was 47.8%. Among the hospitalized patients with diagnostic code of PUB, we ruled out patients with endoscopic removal of gastric adenoma or peritonitis, and selected patients who had been administered intravenous proton pump inhibitor. The sensitivity in this setting was 82.6%, and PPV was 88.4%. PUB was more common in older patients, and there was a clear gender difference in gastric ulcer bleeding by age. With a proper OD using PUB diagnostic codes, we can identify true patients with sufficiently high sensitivity and PPV.

Managing port-site bleeding during less invasive coronary artery bypass grafting.

PubMed

Kiani, Soroosh; Brecht, Mary-Lynn; Lovinger, Katherine; Poston, Robert S

2012-10-01

Robotic-assisted coronary artery bypass grafting (r-CABG) requires the placement of ports bluntly through the chest wall. When removed, these ports create bleeding sites that can be difficult to detect and treat. This study evaluated whether a topical hemostatic agent placed locally within these sites helps to reduce bleeding and blood product requirements. We retrospectively analyzed outcomes for r-CABG cases where 5 mL of a flowable hemostatic agent was injected locally within all port sites (hemostat group, n = 62) compared with patients whose port sites were untreated (controls, n = 131). Outcomes included chest tube output, red blood cell (RBC) transfusions, length of hospital stay, and the risk of reoperation for bleeding. Analyses were adjusted for risk factors known to influence bleeding and Society of Thoracic Surgeons (STS) risk score as a weighted composite of variables, which controls for patient and clinical variables. The 2 study groups had similar baseline characteristics and underwent the same r-CABG procedure. The hemostat group had significant reductions in RBC transfusion (24.2% versus 40.8% receiving blood; P = .026; 0.44 versus 1.39 U transfused postoperatively, P = .024). After adjustment for bleeding risks (using STS risk score), differences in transfusions remained significant. Reoperation rates for bleeding, length of stay, chest tube drainage, and intraoperative transfusions were not significantly different in the 2 groups. There was significantly reduced postoperative bleeding and less exposure to blood products in the hemostat group. These findings suggest that undetected bleeding from sites used for port access serves as an underappreciated source of morbidity after r-CABG.

The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be; Van den Bergh, Laura; Al-Mamgani, Abrahim

2012-03-01

Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including themore » most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions: Comparable prediction models were obtained with LKB, RS, and logistic NTCP models. Including clinical factors improved the predictive power of all models significantly.« less

Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: a "real-world" observational study in the United States.

PubMed

Lip, Gregory Y H; Pan, Xianying; Kamble, Shital; Kawabata, Hugh; Mardekian, Jack; Masseria, Cristina; Bruno, Amanda; Phatak, Hemant

2016-09-01

Limited data are available about the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). To compare the major bleeding risk among newly anticoagulated non-valvular atrial fibrillation (NVAF) patients initiating apixaban, warfarin, dabigatran or rivaroxaban in the United States. A retrospective cohort study was conducted to compare the major bleeding risk among newly anticoagulated NVAF patients initiating warfarin, apixaban, dabigatran or rivaroxaban. The study used the Truven MarketScan(®) Commercial & Medicare supplemental US database from 1 January 2013 through 31 December 2013. Major bleeding was defined as bleeding requiring hospitalisation. Cox model estimated hazard ratios (HRs) of major bleeding were adjusted for age, gender, baseline comorbidities and co-medications. Among 29 338 newly anticoagulated NVAF patients, 2402 (8.19%) were on apixaban; 4173 (14.22%) on dabigatran; 10 050 (34.26%) on rivaroxaban; and 12 713 (43.33%) on warfarin. After adjusting for baseline characteristics, initiation on warfarin [adjusted HR (aHR): 1.93, 95% confidence interval (CI): 1.12-3.33, P=.018] or rivaroxaban (aHR: 2.19, 95% CI: 1.26-3.79, P=.005) had significantly greater risk of major bleeding vs apixaban. Dabigatran initiation (aHR: 1.71, 95% CI: 0.94-3.10, P=.079) had a non-significant major bleeding risk vs apixaban. When compared with warfarin, apixaban (aHR: 0.52, 95% CI: 0.30-0.89, P=.018) had significantly lower major bleeding risk. Patients initiating rivaroxaban (aHR: 1.13, 95% CI: 0.91-1.41, P=.262) or dabigatran (aHR: 0.88, 95% CI: 0.64-1.21, P=.446) had a non-significant major bleeding risk vs warfarin. Among newly anticoagulated NVAF patients in the real-world setting, initiation with rivaroxaban or warfarin was associated with a significantly greater risk of major bleeding compared with initiation on apixaban. When compared with warfarin, initiation with apixaban was associated with significantly lower risk of major bleeding. Additional observational studies are required to confirm these findings. © 2016 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Direct Injection of Blood Products Versus Gelatin Sponge as a Technique for Local Hemostasis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haaga, John; Rahim, Shiraz, E-mail: Shiraz.rahim@uhhospitals.org

PurposeTo provide a method of reducing risk of minimally invasive procedures on patients with abnormal hemostasis and evaluate efficacy of direct fresh frozen plasma injection through a procedure needle tract compared to Gelfoam (gelatin sponge) administration.Materials and MethodsEighty patients with elevated international standardized ratio (INR) undergoing minimally invasive procedures using imaging guidance were selected retrospectively. Forty patients had received Gelfoam as a means of tract embolization during the procedure. The other 40 received local fresh frozen plasma (FFP) through the needle tract. The number of complications and clinically significant bleeding events were recorded. A threshold of 30 cc of blood lossmore » after a procedure was used to identify excess bleeding.ResultsNo patients experienced clinically significant bleeding after administration of FFP. Five patients experienced postoperative drops in hemoglobin or hematomas after administration of Gelfoam.ConclusionLocal injection of blood products can reduce postprocedure bleeding in patients undergoing minimally invasive procedures and provides a safe alternative to the use of synthetic fibrin plugs.« less

Clinical review: Bleeding - a notable complication of treatment in patients with acute coronary syndromes: incidence, predictors, classification, impact on prognosis, and management

PubMed Central

2013-01-01

This article focuses on the incidence, predictors, classification, impact on prognosis, and management of bleeding associated with the treatment of acute coronary syndrome. The issue of bleeding complications is related to the continual improvement of ischemic heart disease treatment, which involves mainly (a) the widespread use of coronary angiography, (b) developments in percutaneous coronary interventions, and (c) the introduction of new antithrombotics. Bleeding has become an important health and economic problem and has an incidence of 2.0% to 17%. Bleeding significantly influences both the short- and long-term prognoses. If a group of patients at higher risk of bleeding complications can be identified according to known risk factors and a risk scoring system can be developed, we may focus more on preventive measures that should help us to reduce the incidence of bleeding. PMID:24093465

MO19390 (SAiL): bleeding events in a phase IV study of first-line bevacizumab with chemotherapy in patients with advanced non-squamous NSCLC.

PubMed

Dansin, Eric; Cinieri, Saverio; Garrido, Pilar; Griesinger, Frank; Isla, Dolores; Koehler, Manfred; Kohlhaeufl, Martin

2012-06-01

The clinical benefit and safety profile associated with first-line bevacizumab with doublet chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC) was established in two large phase III studies, E4599 and AVAiL. SAiL, a single-arm phase IV study, was conducted to evaluate bevacizumab with a range of first-line chemotherapy regimens in a routine oncology practice setting. This analysis of the SAiL data was undertaken to specifically evaluate bleeding adverse events (AEs) in this study, and to explore potential associations between bleeding and baseline patient and disease characteristics. In total, 2212 patients were evaluated. Bleeding AEs (any grade) occurred in 38.2% of patients (grade ≥ 3 bleeding AEs: 3.6%). Grade ≥ 3 pulmonary hemorrhage and central nervous system bleeding events were observed in 0.7% and 0.1% of patients, respectively. The incidence of grade ≥ 3 bleeding AEs was comparable across patient subgroups defined by central tumor location, tumor cavitation, histology, concomitant anticoagulation therapy and age. The majority (88.6%) of bleeding events resolved or improved, 10.2% persisted and 1.3% led to death; 10.2% of bleeding events required bevacizumab interruption or discontinuation. This analysis from the SAiL trial reaffirms a comparable incidence of clinically significant bleeding associated with first-line bevacizumab and chemotherapy as previous phase III studies in NSCLC patients despite less stringent first-line selection criteria. Grade ≥ 3 bleeding appears to be comparable when analyzed for patient and tumor characteristics, including tumor cavitation and concomitant anticoagulation therapy. Most bleeding events resolved or improved, and interruption/discontinuation of bevacizumab was infrequent in a standard oncology practice setting. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Association between gastrointestinal bleeding and 3-year mortality in patients with acute, first-ever ischemic stroke.

PubMed

Chou, Yu-Fang; Weng, Wei-Chieh; Huang, Wen-Yi

2017-10-01

The influence of gastrointestinal bleeding on clinical presentation and outcomes of patients with acute ischemic stroke remains controversial. We investigate the effect of gastrointestinal bleeding on the outcomes of patients with acute, first-ever ischemic stroke. We enrolled 934 patients with acute, first-ever ischemic stroke and followed up them for 3years. Patients were divided into 2 groups according to the presence or absence of gastrointestinal bleeding during acute stroke stage. Clinical presentation, stroke risk factors, laboratory data, co-morbidities, and outcomes were recorded. Seventy-six (8.1%) patients had gastrointestinal bleeding at admission. The prevalence of old age, atrial fibrillation, and previous transient ischemic attack was higher in patients with gastrointestinal bleeding (P<0.001, P=0.038, and P=0.018, respectively). Total anterior circulation syndrome occurred more frequently among patients with gastrointestinal bleeding (P<0.001). The mean length of acute ward stay, initial impaired consciousness, and stroke in evolution were higher in patients with gastrointestinal bleeding (P<0.001, P<0.001, and P<0.001, respectively). The occurrence of pneumonia and dependent functional outcome were higher in patients with gastrointestinal bleeding (P<0.001 and P<0.001, respectively). A multivariate Cox regression analysis revealed that gastrointestinal bleeding is a significant risk factor for 3-year all-cause mortality (hazard ratio=2.76; 95% confidence interval=1.61-4.72; P<0.001). In conclusion, gastrointestinal bleeding is associated with increased risk of 3-year mortality in patients with acute, first-ever ischemic stroke. Prophylactic therapies for gastrointestinal bleeding might improve ischemic stroke outcome. Copyright © 2017 Elsevier Ltd. All rights reserved.

The use of antifibrinolytics in pediatric patients with hypoproliferative thrombocytopenia.

PubMed

Delaney, Meghan; Matthews, Dana C; Gernsheimer, Terry B

2017-12-01

Despite the use of evidence-based platelet transfusion therapy during periods of hypoproliferative thrombocytopenia, a large proportion of pediatric hematology/oncology patients continue to suffer from clinically significant bleeding. Antifibrinolytic (AF) drugs have been shown in certain surgical and trauma settings to decrease bleeding, blood transfusion, and improve survival. We conducted a retrospective assessment of the safety of using AF drugs in pediatric patients with hypoproliferative thrombocytopenia at our center as well as the impact on bleeding occurrence and severity. © 2017 Wiley Periodicals, Inc.

Luteal phase bleeding after IVF cycles: comparison between progesterone vaginal gel and intramuscular progesterone and correlation with pregnancy outcomes

PubMed Central

Jabara, Sami; Barnhart, Kurt; Schertz, Joan C; Patrizio, Pasquale

2009-01-01

Background: To compare luteal phase bleeding and pregnancy outcomes in normogonadotropic patients receiving progesterone vaginal gel (PVG) or intramuscular progesterone (IMP) injections. Methods: In this retrospective cohort study, data from 270 patients (292 cycles) undergoing day-3 fresh embryo transfer were analyzed. PVG, 90 mg daily (170 cycles) or IMP, 50 mg daily (122 cycles) began at egg retrieval. Results: Luteal phase bleeding was significantly more common in the PVG than the IMP group. No significant differences were observed in biochemical pregnancy or spontaneous abortion rates between the two groups. Patients who bled before the pregnancy test had significantly lower total and clinical pregnancy rates than non-bleeders. Total and ongoing pregnancy/delivery rates were higher in the PVG than IMP group, but did not achieve statistical significance. Conclusion: Luteal phase bleeding was more common in the PVG group than the IMP group, but pregnancy was successful in more patients in the PVG group. Luteal phase bleeding is prevented or delayed during IMP treatment, but patients who bled before the pregnancy test, whether using the gel or injected progesterone, had significantly reduced pregnancy rates compared with non-bleeders. PMID:20485581

Bleeding risk in patients with atrial fibrillation: the AMADEUS study.

PubMed

Lane, Deirdre A; Kamphuisen, Pieter W; Minini, Pascal; Büller, Harry R; Lip, Gregory Y H

2011-07-01

This study aimed to assess the impact of combination antithrombotic therapy on stroke and bleeding risk compared with anticoagulation therapy only in patients with atrial fibrillation (AF). Post hoc analysis of 4,576 patients with AF (mean ± SD age, 70.1 ± 9.1 years; men, 66.5%) enrolled in the Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS) trial were randomized to receive either subcutaneous idraparinux (2.5 mg weekly) (n = 2,283) or dose-adjusted vitamin K antagonists (VKAs) (international normalized ratio, 2.0-3.0) (n = 2,293). Of these patients, 848 (18.5%) received antiplatelet therapy (aspirin, clopidogrel, ticlopidine, etc) in addition to anticoagulation treatment (combination antithrombotic therapy). A total of 572 (15.3% per year) clinically relevant bleeding and 103 (2.6% per year) major bleeding events occurred. Patients receiving combination antithrombotic therapy had a 2.3- to 2.5-fold increased risk of clinically relevant bleeding events and major bleeding events, respectively, compared with those receiving anticoagulation therapy only. Multivariate analyses (hazard ratio, 95% CI) revealed that the risk of clinically relevant bleeding was significantly increased by age 65 to 74 years (1.44, 1.14-1.82) and ≥ 75 years (1.59, 1.24-2.04, P = .001) and by combination antithrombotic therapy (2.47, 2.07-2.96, P < .0001). The same held true for major bleeding events, with analogous figures for age 65 to 74 years (2.26, 1.08-4.71) and ≥ 75 years (4.19, 1.98-8.87, P = .0004) and for combination antithrombotic therapy (2.23, 1.49-3.34, P < .0001). Combination antithrombotic therapy was not associated with a decrease in ischemic stroke risk compared with anticoagulation therapy only (11 [1.4% per year] vs 22 [0.7% per year]; adjusted hazard ratio, 2.01; 95% CI, 0.94-4.30; P = .07). Combination antithrombotic therapy increases the risk of clinically relevant bleeding and major bleeding in patients with AF and does not appear to reduce the risk of stroke.

Major bleeding and intracranial hemorrhage risk prediction in patients with atrial fibrillation: Attention to modifiable bleeding risk factors or use of a bleeding risk stratification score? A nationwide cohort study.

PubMed

Chao, Tze-Fan; Lip, Gregory Y H; Lin, Yenn-Jiang; Chang, Shih-Lin; Lo, Li-Wei; Hu, Yu-Feng; Tuan, Ta-Chuan; Liao, Jo-Nan; Chung, Fa-Po; Chen, Tzeng-Ji; Chen, Shih-Ann

2018-03-01

While modifiable bleeding risks should be addressed in all patients with atrial fibrillation (AF), use of a bleeding risk score enables clinicians to 'flag up' those at risk of bleeding for more regular patient contact reviews. We compared a risk assessment strategy for major bleeding and intracranial hemorrhage (ICH) based on modifiable bleeding risk factors (referred to as a 'MBR factors' score) against established bleeding risk stratification scores (HEMORR 2 HAGES, HAS-BLED, ATRIA, ORBIT). A nationwide cohort study of 40,450 AF patients who received warfarin for stroke prevention was performed. The clinical endpoints included ICH and major bleeding. Bleeding scores were compared using receiver operating characteristic (ROC) curves (areas under the ROC curves [AUCs], or c-index) and the net reclassification index (NRI). During a follow up of 4.60±3.62years, 1581 (3.91%) patients sustained ICH and 6889 (17.03%) patients sustained major bleeding events. All tested bleeding risk scores at baseline were higher in those sustaining major bleeds. When compared to no ICH, patients sustaining ICH had higher baseline HEMORR 2 HAGES (p=0.003), HAS-BLED (p<0.001) and MBR factors score (p=0.013) but not ATRIA and ORBIT scores. When HAS-BLED was compared to other bleeding scores, c-indexes were significantly higher compared to MBR factors (p<0.001) and ORBIT (p=0.05) scores for major bleeding. C-indexes for the MBR factors score was significantly lower compared to all other scores (De long test, all p<0.001). When NRI was performed, HAS-BLED outperformed all other bleeding risk scores for major bleeding (all p<0.001). C-indexes for ATRIA and ORBIT scores suggested no significant prediction for ICH. All contemporary bleeding risk scores had modest predictive value for predicting major bleeding but the best predictive value and NRI was found for the HAS-BLED score. Simply depending on modifiable bleeding risk factors had suboptimal predictive value for the prediction of major bleeding in AF patients, when compared to the HAS-BLED score. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial.

PubMed

Jose, Anto; Pratten, Jonathan; Bosma, Mary-Lynn; Milleman, Kimberly R; Milleman, Jeffery L; Wang, Nan

2018-03-01

Short-term use of sodium bicarbonate (NaHCO3)-containing toothpaste reduces plaque and improves clinical measures of gingivitis. To examine this over a longer period, we compared efficacy and tolerability of twice-daily brushing for 24 weeks with 67% or 0% NaHCO3-containing toothpastes in USA-based participants with moderate gingivitis (Clinicaltrials.gov:NCT02207400). This was a six-month, randomized, examiner-blind, parallel-group, clinical trial. Investigators randomized adults with blood in expectorate after brushing and ≥ 20 gingival bleeding sites to 67% NaHCO3 (n = 123; n = 107 completed study) or 0% NaHCO3 (n = 123; n = 109 completed study) toothpastes. Primary efficacy variables included between-treatment differences in number of bleeding sites and Modified Gingival Index (MGI) score at 24 weeks. Secondary efficacy variables included Bleeding Index and Turesky modification of the Quigley-Hein Plaque Index (overall and interproximal sites) at six, 12, and 24 weeks. A subset of 50 participants underwent sampling to assess plaque microbiology over the course of treatment. Compared with the 0% NaHCO3 toothpaste, the 67% NaHCO3 toothpaste produced statistically significant improvements at Week 24 in number of bleeding sites (46.7% difference) and MGI (33.9% difference), and for all other endpoints (all p < 0.0001). There was no significant between-treatment difference in the proportion of participants harboring opportunistic pathogens. Products were generally well tolerated, with two and five treatment-related adverse events reported in the 67% and 0% NaHCO3 toothpaste groups, respectively. Gingival bleeding, gingivitis, and plaque indices were significantly improved at six, 12, and 24 weeks with twice-daily brushing with 67% NaHCO3-containing toothpaste in participants with moderate gingivitis. Copyright© by the YES Group, Inc.

A retrospective explanatory case study of the implementation of a bleeding management quality initiative, in an Australian cardiac surgery unit.

PubMed

Pearse, Bronwyn Louise; Rickard, Claire M; Keogh, Samantha; Lin Fung, Yoke

2018-03-09

Bleeding management in cardiac surgery is challenging. Many guidelines exist to support bleeding management; however, literature demonstrates wide variation in practice. In 2012, a quality initiative was undertaken at The Prince Charles Hospital, Australia to improve bleeding management for cardiac surgery patients. The implementation of the quality initiative resulted in significant reductions in the incidence of blood transfusion, re-exploration for bleeding; superficial leg and chest wound infections; length of hospital stay, and cost. Given the success of the initiative, we sought to answer the question; "How and why was the process of implementing a bleeding management quality initiative in the cardiac surgery unit successful, and sustainable?" A retrospective explanatory case study design was chosen to explore the quality initiative. Analysis of the evidence was reviewed through phases of the 'Knowledgeto Action' planned change model. Data was derived from: (1) document analysis, (2) direct observation of the local environment, (3) clinical narratives from interviews, and analysed with a triangulation approach. The study period extended from 10/2011 to 6/2013. Results demonstrated the complexity of changing practice, as well as the significant amount of dedicated time and effort required to support individual, department and system wide change. Results suggest that while many clinicians were aware of the potential to apply improved practice, numerous barriers and challenges needed to be overcome to implement change across multiple disciplines and departments. The key successful components of the QI were revealed through the case study analysis as: (1) an appropriately skilled project manager to facilitate the implementation process; (2) tools to support changes in workflow and decision making including a bleeding management treatment algorithm with POCCTs; (3) strong clinical leadership from the multidisciplinary team and; (4) the evolution of the project manager position into a perpetual clinical position to support sustainability. Copyright © 2018 Australian College of Critical Care Nurses Ltd. All rights reserved.

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group.

PubMed

Rao, Sunil V; Eikelboom, John; Steg, Ph Gabriel; Lincoff, A Michael; Weintraub, William S; Bassand, Jean-Pierre; Rao, A Koneti; Gibson, C Michael; Petersen, John L; Mehran, Roxana; Manoukian, Steven V; Charnigo, Richard; Lee, Kerry L; Moscucci, Mauro; Harrington, Robert A

2009-12-01

Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

Meta-analysis of major bleeding events on aspirin versus vitamin K antagonists in randomized trials.

PubMed

Ambrosi, P; Daumas, A; Villani, P; Giorgi, R

2017-03-01

The relative bleeding risk of aspirin versus vitamin K antagonists (VKA) is unclear. Most of previous meta-analyses included trials with target INR for VKA therapy far beyond usually recommended range (2-3). The aim of this study was to compare the bleeding risk of aspirin and VKA, as indicated by the aggregate body of clinical evidence including data from the recently published WARCEF trial. In this meta-analysis we included randomized controlled trials that compared aspirin to VKA (1.4

Transcatheter arterial embolisation in upper gastrointestinal bleeding in a sample of 29 patients in a gastrointestinal referral center in Germany.

PubMed

Heining-Kruz, S; Finkenzeller, T; Schreyer, A; Dietl, K H; Kullmann, F; Paetzel, C; Schedel, J

2015-09-01

This is a retrospective analysis of interventional embolisation performed with catheter angiography in 29 patients with upper gastrointestinal bleeding in the setting of a secondary care hospital. From April 2007 to February 2013, 29 patients with upper gastrointestinal bleeding underwent endovascular diagnostics and treatment. The diagnosis was established by endoscopy, computed tomography or clinically based on a significant decrease in hemoglobin. Transcatheter arterial embolisation was performed with coils, liquid embolic agents, and particles. The technical and clinical outcomes were assessed by postinterventional endoscopy, hemoglobin concentrations, number of necessary transfusions, or surgical interventions, as well as by post-interventional mortality within 28 days after the procedure. Selective angiographic embolisation in upper gastrointestinal bleeding was primarily successful technically and clinically in 22 of 29 patients. In 4/29 cases an angiographic reintervention was performed, which was successful in 3 cases. In 3 cases of primarily technically unsuccessful procedures reintervention was not attempted. No catheterisation-related complications were recorded. Peri-interventional mortality was 31%, but only 2 of these patients died due to uncontrolled massive bleeding, whereas the lethal outcome in the other 7 patients was due to their underlying diseases. Transcatheter arterial embolisation is an effective and rapid method in the management of upper gastrointestinal bleeding. Radiological endovascular interventions may considerably contribute to reduced mortality in GI bleeding by avoiding a potential surgical procedure following unsuccessful endoscopic treatment. The study underlines the importance of the combination of interventional endoscopy with interventional radiology in secondary care hospitals for patient outcome in complex and complicated upper gastrointestinal bleeding situations. © Georg Thieme Verlag KG Stuttgart · New York.

Use of Provocative Angiography to Localize Site in Recurrent Gastrointestinal Bleeding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnston, Ciaran, E-mail: ciaranjohnston@yahoo.co.uk; Tuite, David; Pritchard, Ruth

2007-09-15

Background. While the source of most cases of lower gastrointestinal bleeding may be diagnosed with modern radiological and endoscopic techniques, approximately 5% of patients remain who have negative endoscopic and radiological investigations.Clinical Problem. These patients require repeated hospital admissions and blood transfusions, and may proceed to exploratory laparotomy and intraoperative endoscopy. The personal and financial costs are significant. Method of Diagnosis and Decision Making. The technique of adding pharmacologic agents (anticoagulants, vasodilators, fibrinolytics) during standard angiographic protocols to induce a prohemorrhagic state is termed provocative angiography. It is best employed when significant bleeding would otherwise necessitate emergency surgery. Treatment. Thismore » practice frequently identifies a bleeding source (reported success rates range from 29 to 80%), which may then be treated at the same session. We report the case of a patient with chronic lower gastrointestinal hemorrhage with consistently negative endoscopic and radiological workup, who had an occult source of bleeding identified only after a provocative angiographic protocol was instituted, and who underwent succeeding therapeutic coil embolization of the bleeding vessel.« less

Occult hemorrhage in children with severe ITP.

PubMed

Flores, Adolfo; Buchanan, George R

2016-03-01

Little is known about the frequency and significance of clinically unapparent or occult hemorrhage in ITP. Therefore, we prospectively explored the sites and frequency of occult bleeding in children with severe ITP at diagnosis or upon symptomatic relapse in a prospective, single-institution cohort study of patients ≤ 18 years of age and a platelet count ≤ 10,000/mm(3) . Data collected included bleeding severity assessment, urinalysis, fecal occult blood testing, and non-contrast brain MRI. Stool and urine samples were tested within 7 days of diagnosis or symptomatic relapse. Three months after diagnosis or relapse a noncontrast brain MRI evaluated hemosiderin deposits resulting from prior localized hemorrhage. Fifty-two ITP patients were enrolled with a mean platelet count of 4,000/mm(3) . A significant occurrence of occult hemorrhage was identified in the urine (27%) compared with clinically overt hematuria (0.91%, P < 0.0005). CNS microbleeding in the superficial cortex of the left frontal lobe was identified in one child with occult bleeding in the urinary tract. There was no relationship between occult hemorrhage and bleeding manifestations on physical examination. Occult hemorrhage was not a harbinger of subsequent bleeding. Our findings suggest that occult hemorrhage occurs with greater frequency than overt bleeding in children with severe ITP. CNS microbleeding is a potential risk in this patient population. Assessment of brain microbleeds and microscopic hematuria in this patient population require additional study. © 2015 Wiley Periodicals, Inc.

Comparing the effect of mefenamic Acid and vitex agnus on intrauterine device induced bleeding.

PubMed

Yavarikia, Parisa; Shahnazi, Mahnaz; Hadavand Mirzaie, Samira; Javadzadeh, Yousef; Lutfi, Razieh

2013-09-01

Increased bleeding is the most common cause of intrauterine device (IUD) removal. The use of alternative therapies to treat bleeding has increased due to the complications of medications. But most alternative therapies are not accepted by women. Therefore, conducting studies to find the right treatment with fewer complications and being acceptable is necessary. This study aimed to compare the effect of mefenamic acid and vitex agnus castus on IUD induced bleeding. This was a double blinded randomized controlled clinical trial. It was conducted on 84 women with random allocation in to two groups of 42 treated with mefenamic acid and vitex agnus capsules taking three times a day during menstruation for four months. Data were collected by demographic questionnaire and Higham 5 stage chart (1 month before the treatment and 4 months during the treatment)., Paired t-test, independent t-test, chi-square test, analysis of variance (ANOVA) with repeated measurements, and SPSS software were used to determine the results. Mefenamic acid and vitex agnus significantly decreased bleeding. This decrease in month 4 was 52% in the mefenamic acid group and 47.6% in the vitex agnus group. The mean bleeding score changes was statistically significant between the two groups in the first three months and before the intervention. In the mefenamic acid group, the decreased bleeding was significantly more than the vitex agnus group. However, during the 4(th) month, the mean change was not statistically significant. Mefenamic acid and vitex agnus were both effective on IUD induced bleeding; however, mefenamic acid was more effective.

Comparing the Effect of Mefenamic Acid and Vitex Agnus on Intrauterine Device Induced Bleeding

PubMed Central

Yavarikia, Parisa; Shahnazi, Mahnaz; Hadavand Mirzaie, Samira; Javadzadeh, Yousef; Lutfi, Razieh

2013-01-01

Introduction: Increased bleeding is the most common cause of intrauterine device (IUD) removal. The use of alternative therapies to treat bleeding has increased due to the complications of medications. But most alternative therapies are not accepted by women. Therefore, conducting studies to find the right treatment with fewer complications and being acceptable is necessary. This study aimed to compare the effect of mefenamic acid and vitex agnus castus on IUD induced bleeding. Methods: This was a double blinded randomized controlled clinical trial. It was conducted on 84 women with random allocation in to two groups of 42 treated with mefenamic acid and vitex agnus capsules taking three times a day during menstruation for four months. Data were collected by demographic questionnaire and Higham 5 stage chart (1 month before the treatment and 4 months during the treatment)., Paired t-test, independent t-test, chi-square test, analysis of variance (ANOVA) with repeated measurements, and SPSS software were used to determine the results. Results: Mefenamic acid and vitex agnus significantly decreased bleeding. This decrease in month 4 was 52% in the mefenamic acid group and 47.6% in the vitex agnus group. The mean bleeding score changes was statistically significant between the two groups in the first three months and before the intervention. In the mefenamic acid group, the decreased bleeding was significantly more than the vitex agnus group. However, during the 4th month, the mean change was not statistically significant. Conclusion: Mefenamic acid and vitex agnus were both effective on IUD induced bleeding; however, mefenamic acid was more effective. PMID:25276733

Non-steroidal anti-inflammatory drug related upper gastrointestinal bleeding: types of drug use and patient profiles in real clinical practice.

PubMed

Sostres, Carlos; Carrera-Lasfuentes, Patrica; Lanas, Angel

2017-10-01

The best available evidence regarding non-steroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) bleeding comes from randomized controlled trials including patients who use NSAIDs to manage chronic rheumatic diseases; however, patients with varying background profiles commonly take NSAIDs for many other reasons, often without prescription, and such usage has not been well studied. To define the characteristics of patients hospitalized for upper GI bleeding in clinical practice, we conducted a case-control study among patients with endoscopy-proven major upper GI bleeding due to gastroduodenal peptic lesions and control subjects. We used adjusted logistic regression models to estimate bleeding risks. Data analysis was performed using SPSS 22.0. Our analysis included 3785 cases and 6540 controls, including 1270 cases (33.55%) and 834 controls (12.75%) reporting recent use (<30 days) of NSAIDs including high-dose acetylsalicylic acid (ASA). NSAID use was associated with increased risk of upper GI bleeding, with an adjusted relative risk of 4.86 (95% CI, 4.32-5.46). Acute musculoskeletal pain (36.1%), chronic osteoarthritis (13.5%), and headache (13.6%) were the most common reasons for NSAID use. Among cases, only 17.31% took NSAIDs and 6.38% took high dose ASA due to chronic osteoarthritis. Demographic characteristics significantly differed between subjects with chronic vs. acute musculoskeletal pain. Proton pump inhibitor use was significantly higher in patients who used NSAIDs due to chronic osteoarthritis compared to patients with acute musculoskeletal pain. NSAID (65.15%) or high-dose ASA use (65.83%) preceding upper GI bleeding was most often short-term. In over half of cases (63.62%), the upper GI bleeding event was not preceded by dyspeptic warning symptoms. The majority of patients hospitalized due to NSAID-related upper GI bleeding reported short-term NSAID use for reasons other than chronic rheumatic disease. These findings suggest that current prevention strategies may not reach a wide population of short-term NSAID users.

Intracerebral Bleeding and Massive Pericardial Effusion as Presenting Symptoms of Myxedema Crisis

PubMed Central

Rimpau, C.; Nickel, C. H.; Baier, P.

2017-01-01

The endocrinological emergency of a fully blown myxedema crisis can present as a multicolored clinical picture. This can obscure the underlying pathology and easily lead to mistakes in clinical diagnosis, work-up, and treatment. We present a case of an unconscious 39-year-old patient with a medical history of weakness, lethargy, and findings of hyponatremia, intracerebral bleeding, and massive pericardial effusion. Finally, myxedema crisis was diagnosed as underlying cause. Replacement therapy of thyroid hormone and conservative management of the intracerebral bleeding resulted in patient's survival without significant neurological impairment. However, diagnostic pericardiocentesis resulted in life-threatening pericardial tamponade. It is of tremendous importance to diagnose myxoedema crisis early to avoid adverse health outcomes. PMID:28255471

The effect of tranexamic acid for treatment irregular uterine bleeding secondary to DMPA use.

PubMed

Senthong, A-Jaree; Taneepanichskul, Surasak

2009-04-01

Evaluate the efficacy of tranexamic acid and placebo for controlling irregular uterine bleeding in depot-medroxyprogesterone acetate (DMPA) users. A double-blind, placebo-controlled study was conducted on 100 DMPA users attending the Family Planning Clinic King Chulalongkorn Memorial Hospital. All users had abnormal bleeding. They were randomly divided in two groups; a group of 50 received tranexamic acid, 250 mg four times a day for 5 days and another group of 49 received placebo in the same manner. One subject dropped out from the study. Total day of bleeding/spotting and percentage of women in whom bleeding was stopped were analyzed at the end of weeks 1 and 4. The percentage of subjects in whom bleeding was stopped during the first week after initial treatment was significantly higher in the tranexamic acid group than the placebo group (88% vs. 8.2%, p < 0.001). During the follow-up period (4 weeks after initial treatment), a bleeding-free interval of > 20 days was found in 68% of subjects treated with tranexamic acid and 0% treated with placebo(p < 0.001). The mean number of bleeding/spotting days were also significantly different between the groups (5.7 +/- 2.5 vs. 17.5 +/- 7.2 days, p < 0.05). Tranexamic acid was more effective than placebo in short-term treatment of irregular uterine bleeding/spotting associated with DMPA use.

Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists.

PubMed

Eerenberg, E S; Middeldorp, S; Levi, M; Lensing, A W; Büller, H R

2015-09-01

Rivaroxaban is a new oral anticoagulant (NOAC) that can be prescribed in a fixed dose, making regular monitoring and dose adjustments unnecessary. It has been proven to be safe and effective in comparison with enoxaparin/vitamin K antagonists (LMWH/VKA) for the (extended) treatment of venous thromboembolism in the EINSTEIN studies. Nevertheless, there is a need for information regarding the clinical impact of (major) bleeding events with NOACs such as rivaroxaban. A post-hoc analysis was performed to compare the severity of clinical presentation and subsequent clinical course of major bleeding with rivaroxaban vs. LMWH/VKA. Two investigators performed a blinded classification of major bleeding using a priori defined criteria. During the EINSTEIN studies, data concerning the clinical course and measures applied were prospectively collected for each major bleed. Treatment with LMWH/VKA caused more major bleeding events (1.7%) than rivaroxaban (1.0%; hazard ratio, 0.54; 95% confidence interval [CI], 0.37-0.79). Major bleeding events during rivaroxaban therapy had a milder presentation (23% were adjudicated to the worst categories vs. 38% for LMWH/VKA; hazard ratio or HR, 0.35; 95% CI, 0.17-0.74; P = 0.0062). The clinical course was severe in 25% of all major bleeding events associated with rivaroxaban, compared with 33% of LMWH/VKA-associated bleeds (HR, 0.46; 95% CI, 0.22-0.96; P = 0.040). Rivaroxaban-associated major bleeding events occurred less frequently, had a milder presentation and appeared to take a less severe clinical course compared with major bleeding with LMWH/VKA. © 2015 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

The effects of BleedArrest on hemorrhage control in a porcine model.

PubMed

Gegel, Brian; Burgert, James; Loughren, Michael; Johnson, Don

2012-01-01

The purpose of this study was to examine the effectiveness of the hemostatic agent BleedArrest compared to control. This was a prospective, experimental design employing an established porcine model of uncontrolled hemorrhage. The minimum number of animals (n=10 per group) was used to obtain a statistically valid result. There were no statistically significant differences between the groups (P>.05) indicating that the groups were equivalent on the following parameters: activating clotting time, the subject weights, core body temperatures, amount of one minute hemorrhage, arterial blood pressures, and the amount and percentage of total blood volume. There were significant differences in the amount of hemorrhage (P=.033) between the BleedArrest (mean=72, SD±72 mL) and control (mean=317.30, SD±112.02 mL). BleedArrest is statistically and clinically superior at controlling hemorrhage compared to the standard pressure dressing control group. In conclusion, BleedArrest is an effective hemostatic agent for use in civilian and military trauma management.

Pharmacological interventions for stress ulcer prophylaxis in critically ill patients: a mixed treatment comparison network meta-analysis and a recursive cumulative meta-analysis.

PubMed

Sridharan, Kannan; Sivaramakrishnan, Gowri; Gnanaraj, Jerome

2018-02-01

Proton pump inhibitors (PPI), histamine-2 receptor antagonists (H2RA), sucralfate and antacids are the commonly administered agents for stress ulcer prophylaxis (SUP) in critically ill patients. The authors of this paper have conducted a network meta-analysis to compare the efficacy of these agents in SUP. Electronic databases were searched for randomized controlled trials, cohort studies and conference abstracts for studies comparing a SUP agent in critically ill patients to another active SUP agent or placebo. Overt, occult and clinically significant upper gastro-intestinal (UGI) bleeding, all-cause mortality, pneumonia, gastric colonization and ICU length of stay were considered as the outcome measures. A random effects model was used to generate pooled estimates. A total of 53 studies (4258 participants) were included. The pooled estimates were in favor of PPI and sucralfate for the overt UGI bleeding. PPI and H2RA bolus were associated with increased risk of gastric colonization and pneumonia. SUP in critically ill patients was not associated with any benefit with regard to clinically significant bleeding episodes. However, PPI and sucralfate significantly reduces overt UGI bleeding. On the contrary, PPI and H2RA bolus are associated with an increased risk of gastric colonization and pneumonia.

Gamma Knife radiosurgery for cerebral arteriovenous malformations in children/adolescents and adults. Part I: Differences in epidemiologic, morphologic, and clinical characteristics, permanent complications, and bleeding in the latency period

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nicolato, Antonio; Lupidi, Francesco; Section of Stereotactic and Functional Neurosurgery, University of Verona and University Hospital, Verona

Purpose: To compare the epidemiologic, morphologic, and clinical characteristics of 92 children/adolescents (Group A) and 362 adults (Group B) with cerebral arteriovenous malformations (cAVMs) considered suitable for radiosurgery; to correlate radiosurgery-related permanent complication and post-radiosurgery bleeding rates in the 75 children/adolescents and 297 adults available for follow-up. Methods and Materials: Radiosurgery was performed with a model C 201-source Co{sup 6} Leksell Gamma Unit (Elekta Instruments, Stockholm, Sweden). Fisher exact two-tailed, Wilcoxon rank-sum, and two-sample binomial exact tests were used for statistical analysis. Results: There were significant differences between the two populations in sex (p = 0.015), clinical presentation (p =more » 0.001), and location (p = 0.008). The permanent complication rate was lower in younger (1.3%) than in older patients (5.4%), although the difference was not significant (p = 0.213). The postradiosurgery bleeding rate was lower in Group A (1.3%) than in Group B (2.7%) (p = 0.694), with global actuarial bleeding rates of 0.56% per year and 1.15% per year, respectively. Conclusions: The different characteristics of child/adolescent and adult cAVMs suggest that they should be considered two distinct vascular disorders. The similar rates of radiosurgery-related complications and latency period bleeding in the two populations show that gamma knife radiosurgery does not expose young patients to a higher risk of sequelae than that for older patients.« less

Implications of bleeding in acute coronary syndrome and percutaneous coronary intervention

PubMed Central

Pham, Phuong-Anh; Pham, Phuong-Thu; Pham, Phuong-Chi; Miller, Jeffrey M; Pham, Phuong-Mai; Pham, Son V

2011-01-01

The advent of potent antiplatelet and antithrombotic agents over the past decade has resulted in significant improvement in reducing ischemic events in acute coronary syndrome (ACS). However, the use of antiplatelet and antithrombotic combination therapy, often in the settings of percutaneous coronary intervention (PCI), has led to an increase in the risk of bleeding. In patients with non-ST elevation myocardial infarction treated with antithrombotic agents, bleeding has been reported to occur in 0.4%–10% of patients, whereas in patients undergoing PCI, periprocedural bleeding occurs in 2.2%–14% of cases. Until recently, bleeding was considered an intrinsic risk of antithrombotic therapy, and efforts to reduce bleeding have received little attention. There have been increasing data demonstrating that bleeding is associated with adverse outcomes, including myocardial infarction, stroke, and death. Therefore, it is imperative to optimize patient outcomes by adopting pharmacological and nonpharmacological strategies to minimize bleeding while maximizing treatment efficacy. In this paper, we present a review of the bleeding classifications used in large-scale clinical trials in patients with ACS and those undergoing PCI treated with antiplatelets and antithrombotic agents, adverse outcomes, particularly mortality associated with bleeding complications, and suggested predictive risk factors. Potential mechanisms of the association between bleeding and mortality and strategies to reduce bleeding complications are also discussed. PMID:21915172

Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial.

PubMed

Berger, Peter B; Bhatt, Deepak L; Fuster, Valentin; Steg, P Gabriel; Fox, Keith A A; Shao, Mingyuan; Brennan, Danielle M; Hacke, Werner; Montalescot, Gilles; Steinhubl, Steven R; Topol, Eric J

2010-06-15

Uncertainty exists about the frequency, correlates, and clinical significance of bleeding with dual antiplatelet therapy (DAPT), particularly over an extended period in a stable population. We sought to determine the frequency and time course of bleeding with DAPT in patients with established vascular disease or risk factors only; identify correlates of bleeding; and determine whether bleeding is associated with mortality. We analyzed 15 603 patients enrolled in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial, a double-blind, placebo-controlled, randomized trial comparing long-term clopidogrel 75 mg/d versus placebo; all patients received aspirin (75 to 162 mg) daily. Patients had either established stable vascular disease or multiple risk factors for vascular disease without established disease. Median follow-up was 28 months. Bleeding was assessed with the use of the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) criteria. Severe bleeding occurred in 1.7% of the clopidogrel group versus 1.3% on placebo (P=0.087); moderate bleeding occurred in 2.1% versus 1.3%, respectively (P<0.001). The risk of bleeding was greatest the first year. Patients without moderate or severe bleeding during the first year were no more likely than placebo-treated patients to have bleeding thereafter. The frequency of bleeding was similar in patients with established disease and risk factors only. In multivariable analysis, the relationship between moderate bleeding and all-cause mortality was strong (hazard ratio, 2.55; 95% confidence interval, 1.71 to 3.80; P<0.0001), along with myocardial infarction (hazard ratio, 2.92; 95% confidence interval, 2.04 to 4.18; P<0.0001) and stroke (hazard ratio, 4.20; 95% confidence interval, 3.05 to 5.77; P<0.0001). In CHARISMA, there was an increased risk of bleeding with long-term clopidogrel. The incremental risk of bleeding was greatest in the first year and similar thereafter. Moderate bleeding was strongly associated with mortality. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00050817.

Acute bleeding after bone marrow transplantation (BMT)- incidence and effect on survival. A quantitative analysis in 1,402 patients.

PubMed

Nevo, S; Swan, V; Enger, C; Wojno, K J; Bitton, R; Shabooti, M; Fuller, A K; Jones, R J; Braine, H G; Vogelsang, G B

1998-02-15

Acute bleeding after bone marrow transplantation (BMT) was investigated in 1,402 patients receiving transplants at Johns Hopkins Hospital between January 1, 1986 and June 30, 1995. Bleeding categorization was based on daily scores of intensity used by the blood transfusion service. Moderate and severe episodes were analyzed for bleeding sites. Analysis of the cause of death and the interval of the bleeding episode to outcome endpoints was recorded. Survival estimates were computed for 1,353 BMT patients. The overall incidence was 34%. Minor bleeding was seen in 10.6%, moderate bleeding was seen in 11.3%, and severe bleeding was seen in 12% of all patients. Fourteen percent of patients had moderate or severe gastrointestinal hemorrhage, 6.4% had moderate or severe hemorrhagic cystitis, 2.8% had pulmonary hemorrhage, and 2% had intracranial hemorrhage. Sixty-one percent had 1 bleeding site and 34.4% had more than 1 site. Moderate and severe bleeding was more prevalent in allogeneic (31%) and unrelated patients (62.5%) compared with autologous patients (18.5%). Significant distribution of incidence was found among the different diagnoses, but not by disease status in acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma. Bleeding was associated with significantly reduced survival in allogeneic, autologous, and unrelated BMT and in each disease category except multiple myeloma. Survival was correlated with the bleeding intensity, bleeding site, and the number of sites. Although close temporal association was evident to mortality, bleeding was recorded as the cause of death in only the minority of cases compared with other toxicities after BMT (graft-versus-host disease, infections, and preparative regimen toxicity). Acute bleeding is a common complication after BMT that is profoundly associated with morbidity and mortality. Although bleeding was not a direct cause of death in the majority of cases, it has a potential prognostic implication as a predictor of poor outcome in clinical assessment of patients after BMT.

Assessing Bleeding Risk in Patients Taking Anticoagulants

PubMed Central

Shoeb, Marwa; Fang, Margaret C.

2013-01-01

Anticoagulant medications are commonly used for the prevention and treatment of thromboembolism. Although highly effective, they are also associated with significant bleeding risks. Numerous individual clinical factors have been linked to an increased risk of hemorrhage, including older age, anemia, and renal disease. To help quantify hemorrhage risk for individual patients, a number of clinical risk prediction tools have been developed. These risk prediction tools differ in how they were derived and how they identify and weight individual risk factors. At present, their ability to effective predict anticoagulant-associated hemorrhage remains modest. Use of risk prediction tools to estimate bleeding in clinical practice is most influential when applied to patients at the lower spectrum of thromboembolic risk, when the risk of hemorrhage will more strongly affect clinical decisions about anticoagulation. Using risk tools may also help counsel and inform patients about their potential risk for hemorrhage while on anticoagulants, and can identify patients who might benefit from more careful management of anticoagulation. PMID:23479259

Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis.

PubMed

Lip, Gregory Y H; Keshishian, Allison; Kamble, Shital; Pan, Xianying; Mardekian, Jack; Horblyuk, Ruslan; Hamilton, Melissa

2016-10-28

In addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in 'real world' clinical practice. The study used the Truven MarketScan ® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013-31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012-31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39-0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50-0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83-1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36-2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.

Volume of hospital is important for the prognosis of high-risk patients with nonvariceal upper gastrointestinal bleeding (NVUGIB).

PubMed

Choi, Jin Woo; Jeon, Seong Woo; Kwon, Jung Gu; Lee, Dong Wook; Ha, Chang Yoon; Cho, Kwang Bum; Jang, Byung Ik; Park, Jung Bae; Park, Youn Sun

2017-08-01

Nonvariceal upper gastrointestinal bleeding (NVUGIB) is a potentially life-threatening hospital emergency requiring hemodynamic stabilization and resuscitation. This study is carried out to determine whether hospital volume can influence outcome in patients with NVUGIB. This is a retrospective study with a prospective cohort database (KCT 0000514. cris.nih.go.kr). Eight teaching hospitals were divided into two different groups: high-volume centers (HVC, ≥60 NVUGIB patients/year, four clinics) and low-volume centers (LVC, <60 NVUGIB patients/year, four clinics). Baseline characteristics of patients, risk stratification, and outcomes between hospitals of different volumes were compared. From February 2011 to December 2013, a total of 1584 NVUGIB patients enrolled in eight clinics were retrospectively reviewed. The main outcome measurements consisted of continuous bleeding after treatment, re-bleeding, necessity for surgical/other retreatments, and death within 30 days. Similar baseline characters for patients were observed in both groups. There was a significant difference in the incidence of poor outcome between the HVC and LVC groups (9.06 vs. 13.69%, P = 0.014). The incidence rate of poor outcome in high-risk patients (Rockall score ≥8) in HVC was lower than that in high-risk patients in LVC (16.07 vs. 26.92%, P = 0.048); however, there was no significant difference in poor outcome in the lower-risk patients in either group (8.72 vs. 10.42%, P = 0.370). Significant correlation between hospital volume and outcome in NVUGIB patients was observed. Referral to HVC for the management of high-risk NVUGIB patients should be considered in clinical practice.

Intra-alveolar epsilon-aminocaproic acid for the control of post-extraction bleeding in anticoagulated patients: randomized clinical trial.

PubMed

da Silva, R V; Gadelha, T B; Luiz, R R; Torres, S R

2018-03-27

The aim of this study was to compare the effectiveness of the intra-alveolar administration of epsilon-aminocaproic acid (EACA) and daily gentle rinsing with EACA mouthwash with that of routine postoperative procedures for the control of bleeding after tooth extraction in anticoagulated patients. A randomized clinical trial was conducted involving 52 patients submitted to 140 tooth extractions, assigned randomly to two groups. The intervention group was treated with intra-alveolar administration of EACA immediately after surgery and gentle rinsing with EACA mouthwash during the postoperative period. The control group received routine postoperative recommendations. A single episode of immediate bleeding occurred in the intervention group. Late bleeding episodes occurred in 23 procedures (16.4%): 11 (15.7%) in the intervention group and 12 (17.1%) in the control group. Among the patients with late bleeding, 18 (78.3%) events were classified as moderate and were controlled by the patient applying pressure to a gauze pack placed over the extraction socket. The remaining five cases (21.7%) required re-intervention. No statistically significant difference in the frequency of postoperative bleeding was observed between the groups. Thus, routine measures were as effective for the control of bleeding after simple tooth extractions in anticoagulated patients as the topical administration of EACA. Copyright © 2018 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Prognostic Significance of Bleeding Location and Severity Among Patients With Acute Coronary Syndromes

PubMed Central

Vavalle, John P.; Clare, Robert; Chiswell, Karen; Rao, Sunil V.; Petersen, John L.; Kleiman, Neal S.; Mahaffey, Kenneth W.; Wang, Tracy Y.

2013-01-01

Objectives This study sought to determine if there is an association between bleed location and clinical outcomes in acute coronary syndromes (ACS) patients. Background The prognostic significance of bleeding location among ACS patients undergoing cardiac catheterization is not well known. Methods We analyzed in-hospital bleeding events among 9,978 patients randomized in the SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors) study. Bleeding events were categorized by location as access site, systemic, surgical, or superficial, and severity was graded using the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) definition. We assessed the association of each bleeding location and severity with 6-month risk of death or myocardial infarction using a multicovariate-adjusted Cox proportional hazard model. Results A total of 4,900 bleeding events were identified among 3,694 ACS patients with in-hospital bleeding. Among 4,679 GUSTO mild/moderate bleeding events, only surgical and systemic bleeds were associated with an increased risk of 6-month death or myocardial infarction (adjusted hazard ratio [HR]: 2.52 [95% confidence interval (CI): 2.16 to 2.94, and 1.40 [95% CI: 1.16 to 1.69], respectively). Mild/moderate superficial and access-site bleeds were not associated with downstream risk (adjusted HR: 1.17 [95% CI: 0.97 to 1.40], and 0.96 [95% CI: 0.82 to 1.12], respectively). Among 221 GUSTO severe bleeds, surgical bleeds were associated with the highest risk (HR: 5.27 [95% CI: 3.80 to 7.29]), followed by systemic (HR: 4.48 [95% CI: 2.98 to 6.72]), and finally access-site bleeds (HR: 3.57 [95% CI: 2.35 to 5.40]). Conclusions Among ACS patients who develop in-hospital bleeding, systemic and surgical bleeding are associated with the highest risks of adverse outcomes regardless of bleeding severity. Although the most frequent among bleeds, GUSTO mild/moderate access-site bleeding is not associated with increased risk. These data underscore the importance of strategies to minimize overall bleeding risk beyond vascular access site management. PMID:23866183

Neutralization of heparin activity.

PubMed

Pai, Menaka; Crowther, Mark A

2012-01-01

Heparin is the mainstay in the treatment and prevention of thrombosis in such diverse clinical settings as venous thromboembolism, acute coronary syndrome, cardiopulmonary bypass, and hemodialysis. However, the major complication of heparin - like that of all anticoagulants - is bleeding. Heparin may need to be reversed in the following settings: clinically significant bleeding; prior to an invasive procedure; at the conclusion of a procedure involving extracorporeal circulation (e.g., cardiopulmonary bypass, dialysis). This chapter discusses protamine sulfate, as well as several other agents that are able to neutralize heparin, including their pharmacological properties, indications, dosing, and efficacy.

Clinical features of gastroduodenal injury associated with long-term low-dose aspirin therapy

PubMed Central

Iwamoto, Junichi; Saito, Yoshifumi; Honda, Akira; Matsuzaki, Yasushi

2013-01-01

Low-dose aspirin (LDA) is clinically used for the prevention of cardiovascular and cerebrovascular events with the advent of an aging society. On the other hand, a very low dose of aspirin (10 mg daily) decreases the gastric mucosal prostaglandin levels and causes significant gastric mucosal damage. The incidence of LDA-induced gastrointestinal mucosal injury and bleeding has increased. It has been noticed that the incidence of LDA-induced gastrointestinal hemorrhage has increased more than that of non-aspirin non-steroidal anti-inflammatory drug (NSAID)-induced lesions. The pathogenesis related to inhibition of cyclooxygenase (COX)-1 includes reduced mucosal flow, reduced mucus and bicarbonate secretion, and impaired platelet aggregation. The pathogenesis related to inhibition of COX-2 involves reduced angiogenesis and increased leukocyte adherence. The pathogenic mechanisms related to direct epithelial damage are acid back diffusion and impaired platelet aggregation. The factors associated with an increased risk of upper gastrointestinal (GI) complications in subjects taking LDA are aspirin dose, history of ulcer or upper GI bleeding, age > 70 years, concomitant use of non-aspirin NSAIDs including COX-2-selective NSAIDs, and Helicobacter pylori (H. pylori) infection. Moreover, no significant differences have been found between ulcer and non-ulcer groups in the frequency and severity of symptoms such as nausea, acid regurgitation, heartburn, and bloating. It has been shown that the ratios of ulcers located in the body, fundus and cardia are significantly higher in bleeding patients than the ratio of gastroduodenal ulcers in patients taking LDA. Proton pump inhibitors reduce the risk of developing gastric and duodenal ulcers. In contrast to NSAID-induced gastrointestinal ulcers, a well-tolerated histamine H2-receptor antagonist is reportedly effective in prevention of LDA-induced gastrointestinal ulcers. The eradication of H. pylori is equivalent to treatment with omeprazole in preventing recurrent bleeding. Continuous aspirin therapy for patients with gastrointestinal bleeding may increase the risk of recurrent bleeding but potentially reduces the mortality rates, as stopping aspirin therapy is associated with higher mortality rates. It is very important to prevent LDA-induced gastroduodenal ulcer complications including bleeding, and every effort should be exercised to prevent the bleeding complications. PMID:23555156

Validation of prognostic scores for clinical outcomes in cirrhotic patients with acute variceal bleeding.

PubMed

Motola-Kuba, Miguel; Escobedo-Arzate, Angélica; Tellez-Avila, Félix; Altamirano, José; Aguilar-Olivos, Nancy; González-Angulo, Alberto; Zamarripa-Dorsey, Felipe; Uribe, Misael; Chávez-Tapia, Norberto C

Background. The Rockall, Glasgow-Blatchford, and AIMS65 are useful and validated scoring systems for predicting the outcomes of patients with nonvariceal gastrointestinal bleeding. However, there are no validated evidence for using them to predict outcomes on variceal bleeding. The aim of this study was to evaluate and compare the prognostic accuracy of different nonvariceal bleeding scores with other liver-specific scoring systems in cirrhotic patients. A retrospective multicenter study that included 160 cirrhotic patients with acute variceal bleeding. The AUROC's to predict in-hospital mortality, and rebleeding, were analyzed for each scoring system. Overall in-hospital mortality occurred in 13% and in-hospital rebleeding in 12% of patients. The systems with the best AUROC value for predicting mortality were MELD (0.828; 95% CI 0.748-0.909), and AIMS65 (0.817; 95% CI 0.724-0.909). The best score systems for predicting rebleeding were Glasgow-Blatchford (0.756; 95% CI 0.640- 0.827), and Rockall (0.691; 95% CI 0.580-0.802). In addition to liver-specific scores, the AIMS65 score is accurate for predicting in-hospital mortality in cirrhotic patients with acute variceal bleeding. Other scoring systems might be useful for predicting significant clinical outcomes in these patients.

Bleeding risk of patients with acute venous thromboembolism taking nonsteroidal anti-inflammatory drugs or aspirin.

PubMed

Davidson, Bruce L; Verheijen, Sara; Lensing, Anthonie W A; Gebel, Martin; Brighton, Timothy A; Lyons, Roger M; Rehm, Jeffrey; Prins, Martin H

2014-06-01

Combined anticoagulant and aspirin therapy is associated with increased bleeding risk in patients with atrial fibrillation, but the bleeding risk of combined use of anticoagulant and nonsteroidal anti-inflammatory drugs (NSAIDs) is poorly documented. To estimate the bleeding risk of combined anticoagulant (rivaroxaban or enoxaparin-vitamin K antagonist [VKA]) and NSAID or aspirin therapy in patients with venous thromboembolism. Prospective analysis of observational data from the EINSTEIN deep vein thrombosis and pulmonary embolism clinical trials comparing rivaroxaban with enoxaparin-VKA treatment, trials performed in hospitals and clinics in 8246 patients enrolled from 2007 to 2009. Bleeding event rates during exposure to NSAID and aspirin therapy were compared to time without exposure. Days of NSAID or aspirin use and nonuse, clinically relevant bleeding event and major bleeding event rates by patient-years, and hazard ratios. During NSAID-anticoagulant concomitant treatment, clinically relevant bleeding occurred with an event rate of 37.5 per 100 patient-years vs 16.6 per 100 patient-years during anticoagulant use only (hazard ratio [HR], 1.77 [95% CI, 1.46-2.14]). Major bleeding during NSAID-anticoagulant treatment occurred with an event rate of 6.5 per 100 patient-years, compared to 2.0 per 100 patient-years during nonuse (HR, 2.37 [95% CI, 1.51-3.75]). For aspirin-anticoagulant concomitant treatment, clinically relevant bleeding occurred with an event rate of 36.6 per 100 patient-years, compared to 16.9 per 100 patient-years during aspirin nonuse (HR, 1.70 [95% CI, 1.38-2.11]). Major bleeding in aspirin-anticoagulant-treated patients occurred with an event rate of 4.8 per 100 patient-years, compared to 2.2 per 100 patient-years during aspirin nonuse (HR, 1.50 [95% CI, 0.86-2.62]). Increases in risk for clinically relevant and major bleeding were similar for rivaroxaban and enoxaparin-VKA anticoagulation regimens. Among patients with venous thromboembolism receiving anticoagulant therapy, concomitant use of an NSAID or aspirin is associated with an increased risk of clinically relevant and major bleeding.

Short term clinical effectiveness of a 0.07% cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic appliance treatment.

PubMed

Pahwa, Narinder; Kumar, Atul; Gupta, Siddharth

2011-07-01

To test the short term clinical effectiveness of commercially available 0.07%.cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic treatment as compared to a placebo mouth rinse and patients using toothbrush and toothpaste. Forty-five subjects for this double blind study were assigned randomly into three groups of 15 each. Gingival inflammation, plaque accumulation, and bleeding on probing, were recorded at baseline (10 days after prophylaxis), and at the end of one month in all the three groups and compared. Paired t test showed significant differences in bleeding index for pre and post treatment recordings for cetylpyridinium group. Modified gingival index showed no significant difference in the cetylpyridinium group. For plaque index significant difference was found for cetylpyridinium and control groups. Cetylpyridinium mouth rinse 0.7% was found to be effective in reducing the bleeding and plaque index scores. It was not effective in reducing the modified gingival index scores. Cetylpyridinium mouth rinse 0.07% improves the oral hygiene of orthodontic patients when used as an adjunct to normal oral hygiene measures.

Role of Colgate Total toothpaste in helping control plaque and gingivitis.

PubMed

Rover, Jo-Ann; Leu-Wai-See, Petal

2014-06-01

To assess the anti-plaque and anti-gingivitis effects of a dentifrice containing 0.3% triclosan, 2% copolymer and 0.243% (1,100 ppm) sodium fluoride in subjects with moderate plaque-induced gingivitis. This was a single center, monadic study. Subjects had at least 20 teeth remaining in the functional dentition, excluding third molars. Following a baseline examination for plaque, gingival inflammation and bleeding, 75 qualified healthy adult males and females, ages 18-70 were selected to participate in the study. Dental prophylaxis was performed and subjects were provided with two tubes of toothpaste (Colgate Total) and a soft-bristle toothbrush (Colgate Wave Toothbrush). The subjects were instructed to brush twice daily using a modified Bass brushing technique. At the end of the 6- to 8-week period subjects returned for collection of clinical and subjective data. 75 subjects completed the study. Both clinical and subjective reductions were significant. The results showed statistically significant reductions in plaque index, gingival inflammation and bleeding on probing. The overall conclusion was that Colgate Total was a comprehensive dentifrice that produced a significant reduction in gingivitis, plaque, and bleeding.

Factor VII Deficiency: Clinical Phenotype, Genotype and Therapy.

PubMed

Napolitano, Mariasanta; Siragusa, Sergio; Mariani, Guglielmo

2017-03-28

Factor VII deficiency is the most common among rare inherited autosomal recessive bleeding disorders, and is a chameleon disease due to the lack of a direct correlation between plasma levels of coagulation Factor VII and bleeding manifestations. Clinical phenotypes range from asymptomatic condition-even in homozygous subjects-to severe life-threatening bleedings (central nervous system, gastrointestinal bleeding). Prediction of bleeding risk is thus based on multiple parameters that challenge disease management. Spontaneous or surgical bleedings require accurate treatment schedules, and patients at high risk of severe hemorrhages may need prophylaxis from childhood onwards. The aim of the current review is to depict an updated summary of clinical phenotype, laboratory diagnosis, and treatment of inherited Factor VII deficiency.

Factor VII Deficiency: Clinical Phenotype, Genotype and Therapy

PubMed Central

Napolitano, Mariasanta; Siragusa, Sergio; Mariani, Guglielmo

2017-01-01

Factor VII deficiency is the most common among rare inherited autosomal recessive bleeding disorders, and is a chameleon disease due to the lack of a direct correlation between plasma levels of coagulation Factor VII and bleeding manifestations. Clinical phenotypes range from asymptomatic condition—even in homozygous subjects—to severe life-threatening bleedings (central nervous system, gastrointestinal bleeding). Prediction of bleeding risk is thus based on multiple parameters that challenge disease management. Spontaneous or surgical bleedings require accurate treatment schedules, and patients at high risk of severe hemorrhages may need prophylaxis from childhood onwards. The aim of the current review is to depict an updated summary of clinical phenotype, laboratory diagnosis, and treatment of inherited Factor VII deficiency. PMID:28350321

Efficacy and patient satisfaction after NovaSure and Minerva endometrial ablation for treating abnormal uterine bleeding: a retrospective comparative study.

PubMed

Scordalakes, Constantine; delRosario, Robert; Shimer, Andrew; Stankiewicz, Russell

2018-01-01

Compare amenorrhea rate, menstrual symptoms, patient satisfaction, and adverse events in women who underwent endometrial ablation with the NovaSure versus the Minerva radiofrequency ablation systems. We surveyed 189 premenopausal women (mean 40.8±6.2 years old) who underwent endometrial ablation for abnormal uterine bleeding using the NovaSure (n=97) or Minerva (n=92) systems, at four private US gynecology clinics, and whose procedure date was after July 2015 with follow-up ≥3 months. Women were surveyed an average of 11.3±3.9 months (range 137-532 days) after ablation. The subject-reported amenorrhea rate was 52% higher in NovaSure subjects than Minerva subjects (64% and 42%, respectively; p =0.004). Age and bleeding cyclicity did not affect amenorrhea rate in either group. Normal-to-no bleeding was reported by >90% of subjects after either treatment. NovaSure was significantly more effective than Minerva at reducing pad/tampon use in women with any residual bleeding (2.4±5.2 items/day versus 4.7±5.5 items/day, p =0.049). NovaSure was significantly more effective than Minerva at reducing premenstrual syndrome (PMS) symptoms ( p =0.019) and menstrual pain ( p =0.003), and more NovaSure subjects (94%) than Minerva subjects (78%) were satisfied with clinical outcomes ( p =0.003). Adverse events did not differ by treatment; three women in each group progressed to hysterectomy. While overall bleeding reduction in premenopausal women with abnormal uterine bleeding was excellent with either endometrial ablation system, NovaSure treatment resulted in a higher patient-reported 1-year amenorrhea rate, and women with residual bleeding used fewer pads and tampons than Minerva-treated women. Additionally, NovaSure subjects reported better menstrual-related life quality and PMS symptom alleviation, and greater satisfaction with outcomes than Minerva-treated women.

Origin, Clinical Characteristics and 30-Day Outcomes of Severe Hematochezia in Cirrhotics and Non-cirrhotics

PubMed Central

Khungar, Vandana; Jensen, Dennis M.; Ohning, Gordon V.; Kovacs, Thomas O.; Jutabha, Rome; Ghassemi, Kevin A.; Machicado, Gustavo A.; Dulai, Gareth S.

2017-01-01

Background The sites of origin, causes and outcomes of severe hematochezia have not been compared between cirrhotics and non-cirrhotics. In cirrhotics versus non-cirrhotics presenting with severe hematochezia, we aimed at (1) identifying the site and etiology of gastro-intestinal bleeding and independent predictors of bleeding from the upper gastrointestinal tract versus small bowel or the colon, (2) comparing 30-day clinical outcomes, and (3) proposing an algorithm for management of severe hematochezia. Methods In this cohort study from two university-based medical centers, 860 consecutive patients with severe hematochezia admitted from 1995 to 2011 were prospectively enrolled with 160 (18.6 %) cirrhotics. We studied (a) general clinical and laboratory characteristics of cirrhotics versus non-cirrhotics, (b) predictors of bleeding sites in each patient group by multiple variable regression analysis, and compared (c) 30-day outcomes, including rebleeding, surgery and deaths. Results Cirrhosis independently predicted an upper gastrointestinal source of bleeding (OR 3.47; 95 % CI 2.01–5.96) as well as history of hematemesis, melena in the past 30 days, positive nasogastric aspirate, prior upper gastrointestinal bleeding or use of aspirin or non-steroidal anti-inflammatory. The most prevalent diagnoses were esophageal varices (20 %) in cirrhotics and colon diverticular bleeding (27.1 %) in non-cirrhotics. Thirty-day rates of rebleeding, surgical interventions and deaths were 23.1 versus 15 % (P = 0.01), 14.4 versus 6.4 % (P < 0.001), and 17.5 versus 4.1 % (P < 0.001), in cirrhotics versus non-cirrhotics, respectively. Conclusions Cirrhosis predicted an upper gastrointestinal site of bleeding in patients presenting with severe hematochezia. The 30-day rates of rebleeding, surgery, and death were significantly higher in cirrhotics than in non-cirrhotics. PMID:27286877

Predictors of a variceal source among patients presenting with upper gastrointestinal bleeding.

PubMed

Alharbi, Ahmad; Almadi, Majid; Barkun, Alan; Martel, Myriam

2012-04-01

Patients with upper gastrointestinal bleeding (UGIB) require an early, tailored approach best guided by knowledge of the bleeding lesion, especially a variceal versus a nonvariceal source. To identify, by investigating a large national registry, variables that would be predictive of a variceal origin of UGIB using clinical parameters before endoscopic evaluation. A retrospective study was conducted in 21 Canadian hospitals during the period from January 2004 until the end of May 2005. Consecutive charts for hospitalized patients with a primary or secondary discharge diagnosis of UGIB were reviewed. Data regarding demographics, including historical, physical examination, initial laboratory investigations, endoscopic and pharmacological therapies administered, as well as clinical outcomes, were collected. Multivariable logistic regression modelling was performed to identify clinical predictors of a variceal source of bleeding. The patient population included 2020 patients (mean [± SD] age 66.3±16.4 years; 38.4% female). Overall, 215 (10.6%) were found to be bleeding from upper gastrointestinal varices. Among 26 patient characteristics, variables predicting a variceal source of bleeding included history of liver disease (OR 6.36 [95% CI 3.59 to 11.3]), excessive alcohol use (OR 2.28 [95% CI 1.37 to 3.77]), hematemesis (OR 2.65 [95% CI 1.61 to 4.36]), hematochezia (OR 3.02 [95% CI 1.46 to 6.22]) and stigmata of chronic liver disease (OR 2.49 [95% CI 1.46 to 4.25]). Patients treated with antithrombotic therapy were more likely to experience other causes of hemorrhage (OR 0.44 [95% CI 0.35 to 0.78]). Presenting historical and physical examination data, and initial laboratory tests carry significant predictive ability in discriminating variceal versus nonvariceal sources of bleeding.

Risk of stroke/systemic embolism, major bleeding and associated costs in non-valvular atrial fibrillation patients who initiated apixaban, dabigatran or rivaroxaban compared with warfarin in the United States Medicare population.

PubMed

Amin, Alpesh; Keshishian, Allison; Trocio, Jeffrey; Dina, Oluwaseyi; Le, Hannah; Rosenblatt, Lisa; Liu, Xianchen; Mardekian, Jack; Zhang, Qisu; Baser, Onur; Vo, Lien

2017-09-01

To compare the risk and cost of stroke/systemic embolism (SE) and major bleeding between each direct oral anticoagulant (DOAC) and warfarin among non-valvular atrial fibrillation (NVAF) patients. Patients (≥65 years) initiating warfarin or DOACs (apixaban, rivaroxaban, and dabigatran) were selected from the Medicare database from 1 January 2013 to 31 December 2014. Patients initiating each DOAC were matched 1:1 to warfarin patients using propensity score matching to balance demographics and clinical characteristics. Cox proportional hazards models were used to estimate the risks of stroke/SE and major bleeding of each DOAC vs. warfarin. Two-part models were used to compare the stroke/SE- and major-bleeding-related medical costs between matched cohorts. Of the 186,132 eligible patients, 20,803 apixaban-warfarin pairs, 52,476 rivaroxaban-warfarin pairs, and 16,731 dabigatran-warfarin pairs were matched. Apixaban (hazard ratio [HR] = 0.40; 95% confidence interval [CI] 0.31, 0.53) and rivaroxaban (HR = 0.72; 95% CI 0.63, 0.83) were significantly associated with lower risk of stroke/SE compared to warfarin. Apixaban (HR = 0.51; 95% CI 0.44, 0.58) and dabigatran (HR = 0.79; 95% CI 0.69, 0.91) were significantly associated with lower risk of major bleeding; rivaroxaban (HR = 1.17; 95% CI 1.10, 1.26) was significantly associated with higher risk of major bleeding compared to warfarin. Compared to warfarin, apixaban ($63 vs. $131) and rivaroxaban ($93 vs. $139) had significantly lower stroke/SE-related medical costs; apixaban ($292 vs. $529) and dabigatran ($369 vs. $450) had significantly lower major bleeding-related medical costs. Among the DOACs in the study, only apixaban is associated with a significantly lower risk of stroke/SE and major bleeding and lower related medical costs compared to warfarin.

Effect of home testing of international normalized ratio on clinical events.

PubMed

Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip

2010-10-21

Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes. We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death). The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin therapy. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT00032591.).

Rectal bleeding in patients with haemorrhoids. Coincidental findings in colon and rectum.

PubMed

Koning, M V; Loffeld, R J L F

2010-06-01

Rectal bleeding is a very common clinical sign. It is often caused by haemorrhoids. However, it can be a symptom of other pathology in the rectum or colon. There are little data coincidental pathology in patients with haemorrhoids and rectal bleeding. To examine coincidental pathology in patients with rectal bleeding and haemorrhoids, especially with respect to age. Prospectively, 290 consecutive patients presenting with bleeding and haemorrhoids were analysed. All patients had an endoscopic examination. All significant endoscopic findings (diverticuli, polyps, cancer, angiodysplasia and varices or colitis) were recorded. The patients were divided into two groups. Group 1 consisted of patients with only haemorrhoids (n = 129, % male: 41.1, mean age: 53.6 +/- 12.7 years). Group 2 consisted of patients with haemorrhoids and coincidental pathology (n = 161, % male: 46.6, mean age: 67.3 +/- 13.7 years). There was no difference in gender or in the type of endoscopy. However, patients in Group 2 were significantly older. It can be concluded that in cases of rectal bleeding and haemorrhoids, coincidental pathology occurs in a large proportion of patients, especially the elderly. Omitting endoscopy in these patients can lead to major doctors delay.

Establishment of a bleeding score as a diagnostic tool for patients with rare bleeding disorders.

PubMed

Palla, Roberta; Siboni, Simona M; Menegatti, Marzia; Musallam, Khaled M; Peyvandi, Flora

2016-12-01

Bleeding manifestations among patients with rare bleeding disorders (RBDs) vary significantly between disorders and patients, even when affected with the same disorder. In response to the challenge represented by the clinical assessment of the presence and severity of bleeding symptoms, a number of bleeding score systems (BSSs) or bleeding assessment tools (BATs) were developed. The majority of these were specifically developed for patients with more common bleeding disorders than RBDs. Few RBDs patients were evaluated with these tools and without conclusive results. A new BSS was developed using data retrieved from a large group of patients with RBDs enrolled in the EN-RBD database and from healthy subjects. These data included previous bleeding symptoms, frequency, spontaneity, extent, localization, and relationship to prophylaxis and acute treatment. The predictive power of this BSS was also compared with the ISTH-BAT and examined for the severity of RBDs based on coagulant factor activity. This BSS was able to differentiate patients with RBDs from healthy individuals with a bleeding score value of 1.5 having the highest sum of sensitivity (67.1%) and specificity (73.8%) in discriminating patients with RBD from those without. An easy-to-use calculation was also developed to assess the probability of having a RBD. Its comparison with the ISTH-BAT confirmed its utility. Finally, in RBDs patients, there was a significant negative correlation between BS and coagulant factor activity level, which was strongest for fibrinogen and FXIII deficiencies. The use of this quantitative method may represent a valuable support tool to clinicians. Copyright © 2016 Elsevier Ltd. All rights reserved.

Therapeutic Decision-Making in Endoscopically Unmanageable Nonvariceal Upper Gastrointestinal Hemorrhage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Defreyne, Luc, E-mail: Luc.Defreyne@UGent.b; Schrijver, Ignace De; Decruyenaere, Johan

2008-09-15

The purpose of this study was to identify endoscopic and clinical parameters influencing the decision-making in salvage of endoscopically unmanageable, nonvariceal upper gastrointestinal hemorrhage (UGIH) and to report the outcome of selected therapy. We retrospectively retrieved all cases of surgery and arteriography for arrest of endoscopically unmanageable UGIH. Only patients with overt bleeding on endoscopy within the previous 24 h were included. Patients with preceding nonendoscopic hemostatic interventions, portal hypertension, malignancy, and transpapillar bleeding were excluded. Potential clinical and endoscopic predictors of allocation to either surgery or arteriography were tested using statistical models. Outcome and survival were regressed on themore » choice of rescue and clinical variables. Forty-six arteriographed and 51 operated patients met the inclusion criteria. Univariate analysis revealed a higher number of patients with a coagulation disorder in the catheterization group (41.4%, versus 20.4% in the laparotomy group; p = 0.044). With multivariate analysis, the identification of a bleeding peptic ulcer at endoscopy significantly steered decision-making toward surgical rescue (OR = 5.2; p = 0.021). Taking into account reinterventions, hemostasis was achieved in nearly 90% of cases in both groups. Overall therapy failure (no survivors), rebleeding within 3 days (OR = 3.7; p = 0.042), and corticosteroid use (OR = 5.2; p = 0.017) had a significant negative impact on survival. The odds of dying were not different for embolotherapy or surgery. In conclusion, decision-making was endoscopy-based, with bleeding peptic ulcer significantly directing the choice of rescue toward surgery. Unsuccessful hemostasis and corticosteroid use, but not the choice of rescue, negatively affected outcome.« less

[Abnormality of blood coagulation indexes in patients with de novo acute leukemia and its clinical significance].

PubMed

Xiao, Fang-Fang; Hu, Kai-Xun; Guo, Mei; Qiao, Jian-Hui; Sun, Qi-Yun; Ai, Hui-Sheng; Yu, Chang-Lin

2013-04-01

To explore hemorrhage risk and the clinical significance of abnormal change of prothrombin time (PT), activated partial thromboplastin time (APTT), plasma fibrinogen (FIB), plasma thrombin time (TT) and d-dimer (D-D) in de novo acute leukemia (except for APL), the different bleeding manifestations of 114 cases of de novo acute leukemia with different coagulation indexes were analyzed retrospectively. The correlation between these blood coagulation indexes and the possible correlative clinical characteristics were analysed, including age, sex, type of acute leukemia, initial white blood cell(WBC) and platelet(Plt) count, the proportion of blast cells in bone marrow and cytogenetic abnormality of patients at diagnosis. The results indicated that the incidence of abnormal blood coagulation was as high as 78.1% for de novo AL patients. These patients with 5 normal blood coagulation indexes may have mild bleeding manifestation, but the more abnormal indexes, the more severe bleeding. Both PT and D-D were sensitive indexes for diagnosis of level II bleeding. Incidence of abnormal blood coagulation significantly correlates with the proportion of blast cells in bone marrow (χ(2) = 4.184, OR = 1.021, P < 0.05) and more with D-D (P < 0.01), while age, sex, type of AL, WBC count, Plt count and abnormality of cytogenetics did not correlate with abnormal blood coagulation. It is concluded that the coagulation and fibrinolysis are abnormal in most patients with de novo acute leukemia. More abnormal indexes indicate more severe bleeding, and both PT and D-D are sensitive indexes for diagnosis of level II bleeding. Higher proportion of blast cells in bone marrow predicts higher incidence of abnormal blood clotting. Acute leukemia with elderly age, high white blood cell count and adverse cytogenetics do not predict severer abnormal blood clotting. Detection of PT, APTT, TT, FIB, and D-D may help to judge whether the patients are in a state of hypercoagulability or disseminated intravenous coagulation, which will provide experiment evidences for early intervention and medication.

Gastrointestinal Bleeding in Patients With Atrial Fibrillation Treated With Rivaroxaban or Warfarin: ROCKET AF Trial.

PubMed

Sherwood, Matthew W; Nessel, Christopher C; Hellkamp, Anne S; Mahaffey, Kenneth W; Piccini, Jonathan P; Suh, Eun-Young; Becker, Richard C; Singer, Daniel E; Halperin, Jonathan L; Hankey, Graeme J; Berkowitz, Scott D; Fox, Keith A A; Patel, Manesh R

2015-12-01

Gastrointestinal (GI) bleeding is a common complication of oral anticoagulation. This study evaluated GI bleeding in patients who received at least 1 dose of the study drug in the on-treatment arm of the ROCKET AF (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial. The primary outcome was adjudicated GI bleeding reported from first to last drug dose + 2 days. Multivariable modeling was performed with pre-specified candidate predictors. Of 14,236 patients, 684 experienced GI bleeding during follow-up. These patients were older (median age 75 years vs. 73 years) and less often female. GI bleeding events occurred in the upper GI tract (48%), lower GI tract (23%), and rectum (29%) without differences between treatment arms. There was a significantly higher rate of major or nonmajor clinical GI bleeding in rivaroxaban- versus warfarin-treated patients (3.61 events/100 patient-years vs. 2.60 events/100 patient-years; hazard ratio: 1.42; 95% confidence interval: 1.22 to 1.66). Severe GI bleeding rates were similar between treatment arms (0.47 events/100 patient-years vs. 0.41 events/100 patient-years; p = 0.39; 0.01 events/100 patient-years vs. 0.04 events/100 patient-years; p = 0.15, respectively), and fatal GI bleeding events were rare (0.01 events/100 patient-years vs. 0.04 events/100 patient-years; 1 fatal events vs. 5 fatal events total). Independent clinical factors most strongly associated with GI bleeding were baseline anemia, history of GI bleeding, and long-term aspirin use. In the ROCKET AF trial, rivaroxaban increased GI bleeding compared with warfarin. The absolute fatality rate from GI bleeding was low and similar in both treatment arms. Our results further illustrate the need for minimizing modifiable risk factors for GI bleeding in patients on oral anticoagulation. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Reduced thrombin formation and excessive fibrinolysis are associated with bleeding complications in patients with dengue fever: a case–control study comparing dengue fever patients with and without bleeding manifestations

PubMed Central

2013-01-01

Background Dengue cases have been classified according to disease severity into dengue fever (DF) and dengue hemorrhagic fever (DHF). Although DF is considered a non-severe manifestation of dengue, it has been recently demonstrated that DF represents a heterogeneous group of patients with varied clinical complications and grades of severity. Particularly, bleeding complications, commonly associated to DHF, can be detected in half of the patients with DF. Although a frequent complication, the causes of bleedings in DF have not been fully addressed. Thus, the aim of this study was to perform a comprehensive evaluation of possible pathophysiological mechanisms that could contribute to the bleeding tendency observed in patients with DF. Methods This is a case–control study that enrolled adults with DF without bleeding and adults with DF and bleeding complications during the defervescence period. Healthy controls were also included. Peripheral blood counts, inflammatory, fibrinolysis and endothelial cell activation markers, and thrombin generation were evaluated in patients and controls. Results We included 33 adults with DF without complications, 26 adults with DF and bleeding and 67 healthy controls. Bleeding episodes were mild in 15 (57.6%) and moderate in 11 (42.4%) patients, 8 (30.7%) patients had bleedings in multiple sites. Patients with DF and bleedings had lower platelet counts than DF without bleeding (median = 19,500 vs. 203,500/mm3, P < 0,0001). Levels of TNF-α, thrombomodulin and VWF were significantly increased in the two dengue groups than in healthy controls, but similar between patients with and without bleedings. Plasma levels of tPA and D-dimer were significantly increased in patients with bleedings (median tPA levels were 4.5, 5.2, 11.7 ng/ml, P < 0.0001 and median D-dimer levels were 515.5, 1028 and 1927 ng/ml, P < 0.0001). The thrombin generation test showed that patients with bleeding complications had reduced thrombin formation (total thrombin generated were 3753.4 in controls, 3367.5 in non-bleeding and 2274.5nM in bleeding patients, P < 0.002). Conclusions DF can manifest with spontaneous bleedings, which are associated with specific coagulation and fibrinolysis profiles that are not significantly present in DF without this complication. Particularly, thrombocytopenia, excessive fibrinolysis and reduced thrombin formation may contribute to the bleeding manifestations in DF. PMID:23890510

Reduced thrombin formation and excessive fibrinolysis are associated with bleeding complications in patients with dengue fever: a case-control study comparing dengue fever patients with and without bleeding manifestations.

PubMed

Orsi, Fernanda A; Angerami, Rodrigo N; Mazetto, Bruna M; Quaino, Susan K P; Santiago-Bassora, Fernanda; Castro, Vagner; de Paula, Erich V; Annichino-Bizzacchi, Joyce M

2013-07-28

Dengue cases have been classified according to disease severity into dengue fever (DF) and dengue hemorrhagic fever (DHF). Although DF is considered a non-severe manifestation of dengue, it has been recently demonstrated that DF represents a heterogeneous group of patients with varied clinical complications and grades of severity. Particularly, bleeding complications, commonly associated to DHF, can be detected in half of the patients with DF. Although a frequent complication, the causes of bleedings in DF have not been fully addressed. Thus, the aim of this study was to perform a comprehensive evaluation of possible pathophysiological mechanisms that could contribute to the bleeding tendency observed in patients with DF. This is a case-control study that enrolled adults with DF without bleeding and adults with DF and bleeding complications during the defervescence period. Healthy controls were also included. Peripheral blood counts, inflammatory, fibrinolysis and endothelial cell activation markers, and thrombin generation were evaluated in patients and controls. We included 33 adults with DF without complications, 26 adults with DF and bleeding and 67 healthy controls. Bleeding episodes were mild in 15 (57.6%) and moderate in 11 (42.4%) patients, 8 (30.7%) patients had bleedings in multiple sites. Patients with DF and bleedings had lower platelet counts than DF without bleeding (median = 19,500 vs. 203,500/mm3, P < 0,0001). Levels of TNF-α, thrombomodulin and VWF were significantly increased in the two dengue groups than in healthy controls, but similar between patients with and without bleedings. Plasma levels of tPA and D-dimer were significantly increased in patients with bleedings (median tPA levels were 4.5, 5.2, 11.7 ng/ml, P < 0.0001 and median D-dimer levels were 515.5, 1028 and 1927 ng/ml, P < 0.0001). The thrombin generation test showed that patients with bleeding complications had reduced thrombin formation (total thrombin generated were 3753.4 in controls, 3367.5 in non-bleeding and 2274.5nM in bleeding patients, P < 0.002). DF can manifest with spontaneous bleedings, which are associated with specific coagulation and fibrinolysis profiles that are not significantly present in DF without this complication. Particularly, thrombocytopenia, excessive fibrinolysis and reduced thrombin formation may contribute to the bleeding manifestations in DF.

Comparative study of vaginal danazol vs diphereline (a synthetic GnRH agonist) in the control of bleeding during hysteroscopic myomectomy in women with abnormal uterine bleeding: a randomized controlled clinical trial.

PubMed

Sayyah-Melli, M; Bidadi, S; Taghavi, S; Ouladsahebmadarek, E; Jafari-Shobeiri, M; Ghojazadeh, M; Rahmani, V

2016-01-01

To compare the usefulness of vaginal danazol and diphereline in the management of intra-operative bleeding during hysteroscopy. Randomized controlled clinical trial. University hospital. One hundred and ninety participants of reproductive age were enrolled for operative hysteroscopy. Thirty women were excluded from the study. One hundred and sixty participants with submucous myomas were allocated at random to receive either vaginal danazol (200mg BID, 30 days before surgery) or intramuscular diphereline (twice with a 28-day interval). Severity of intra-operative bleeding, clarity of the visual field, volume of media, operative time, success rate for completion of operation and postoperative complications. Overall, 145 patients completed the study. In the danazol group, 78.1% of patients experienced no intra-operative uterine bleeding, and 21.9% experienced mild bleeding. In the diphereline group, 19.4% of patients experienced no intra-operative uterine bleeding, but mild, moderate and severe bleeding was observed in 31.9%, 45.8% and 2.8% of patients, respectively. The difference between the groups was significant (p<0.001). A clear visual field was reported more frequently in the danazol group compared with the diphereline group (98.6% vs 29.2%, p<0.001). The mean operative time was 10.9 min and 10.6 min in the danazol and diphereline groups, respectively (p=0.79). The mean volume of infused media was 2.0L in both groups (p=0.99). The success rate was 100% for both groups with no intra-operative complications. Both vaginal danazol and diphereline were effective in controlling uterine bleeding during operative hysteroscopy. However, vaginal danazol provided a clearer visual field. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Upper gastrointestinal bleeding caused by severe esophagitis: a unique clinical syndrome.

PubMed

Guntipalli, Prathima; Chason, Rebecca; Elliott, Alan; Rockey, Don C

2014-12-01

We have recognized a unique clinical syndrome in patients with upper gastrointestinal bleeding who are found to have severe esophagitis. We aimed to more clearly describe the clinical entity of upper gastrointestinal bleeding in patients with severe esophagitis. We conducted a retrospective matched case-control study designed to investigate clinical features in patients with carefully defined upper gastrointestinal bleeding and severe esophagitis. Patient data were captured prospectively via a Gastrointestinal Bleeding Healthcare Registry, which collects data on all patients admitted with gastrointestinal bleeding. Patients with endoscopically documented esophagitis (cases) were matched with randomly selected controls that had upper gastrointestinal bleeding caused by other lesions. Epidemiologic features in patients with esophagitis were similar to those with other causes of upper gastrointestinal bleeding. However, hematemesis was more common in patients with esophagitis 86% (102/119) than in controls 55% (196/357) (p < 0.0001), while melena was less common in patients with esophagitis 38% (45/119) than in controls 68% (244/357) (p < 0.0001). Additionally, the more severe the esophagitis, the more frequent was melena. Patients with esophagitis had less abnormal vital signs, lesser decreases in hematocrit, and lesser increases in BUN. Both pre- and postRockall scores were lower in patients with esophagitis compared with controls (p = 0.01, and p < 0.0001, respectively). Length of hospital stay (p = 0.002), rebleeding rate at 42 days (p = 0.0007), and mortality were less in patients with esophagitis than controls. Finally, analysis of patients with esophagitis and cirrhosis suggested that this group of patients had more severe bleeding than those without cirrhosis. We have described a unique clinical syndrome in patients with upper gastrointestinal bleeding who have erosive esophagitis. This syndrome is manifest by typical clinical features and is associated with favorable outcomes.

A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

PubMed

Li, Zhen; He, Tao; Li, Chun; Sun, Lily; Chang, Jinlan; He, Yanyan; Zhao, Jizhi; Ji, Ning

2016-08-01

To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (P< 0.001). At Months 1, 2 and 3, the power toothbrush demonstrated significantly greater gingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (P< 0.01), and significantly fewer bleeding sites (17.3%, 23.9% and 24.3%, respectively, P< 0.05). No adverse events were reported or observed for either brush during the study. The power brush provided statistically significantly greater reductions in gingivitis compared with a manual toothbrush at Months 1, 2 and 3.

Sex-related differences in outcomes among men and women under 55 years of age with acute coronary syndrome undergoing percutaneous coronary intervention: Results from the PROMETHEUS study.

PubMed

Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Faggioni, Michela; Aquino, Melissa; Kini, Annapoorna; Weintraub, William; Rao, Sunil; Kapadia, Samir; Weiss, Sandra; Strauss, Craig; Toma, Catalin; Muhlestein, Brent; DeFranco, Anthony; Effron, Mark; Keller, Stuart; Baker, Brian; Pocock, Stuart; Henry, Timothy; Mehran, Roxana

2017-03-01

Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort. PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression. The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P < 0.001) and bleeding (3.6% vs. 2.2%, P = 0.01) was significantly higher in women compared with men, but these results were no longer significant after adjustment for risk (HR 1.13, 95% CI 0.94-1.36 for MACE and HR 1.31, 95% CI 0.85-2.04 for bleeding). Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Impact of Body Mass Index and Genetics on Warfarin Major Bleeding Outcomes in a Community Setting.

PubMed

Hart, Ragan; Veenstra, David L; Boudreau, Denise M; Roth, Joshua A

2017-02-01

Several studies have demonstrated an association between body mass index (BMI) and warfarin therapeutic dose, but none evaluated the association of BMI with the clinically important outcome of major bleeding in a community setting. To address this evidence gap, we conducted a case-control study to evaluate the association between BMI and major bleeding risk among patients receiving warfarin. We used a case-control study design to evaluate the association between obesity (BMI >30.0 kg/m 2 ) and major bleeding risk among 265 cases and 305 controls receiving warfarin at Group Health, an integrated healthcare system in Washington State. Multivariate logistic regression was used to adjust for potential confounders derived from health plan records and a self-report survey. In exploratory analyses we evaluated the interaction between genetic variants potentially associated with warfarin bleeding (CYP2C9, VKORC1, and CYP4F2) and obesity on the risk of major bleeding. Overall, the sample was 55% male, 94% Caucasian, and mean age was 70 years. Cases and controls had an average of 3.4 and 3.7 years of warfarin use, respectively. Obese patients had significantly lower major bleeding risk relative to non-obese patients (odds ratio [OR] 0.60, 95% confidence interval [CI] 0.39-0.92). The OR was 0.56 (95% CI 0.35-0.90) in patients with ≥1 year of warfarin use, and 0.78 (95% CI 0.40-1.54) in patients with <1 year of warfarin use. An exploratory analysis indicated a statistically significant interaction between CYP4F2*3 genetic status and obesity (P = .049), suggesting a protective effect of obesity on the risk of major bleeding among those wild type for CYP4F2*3, but not among variants. Our findings suggest that BMI is an important clinical factor in assessing and managing warfarin therapy. Future studies should confirm the major bleeding associations, including the interaction between obesity and CYP4F2*3 status identified in this study, and evaluate potential mechanisms. Copyright © 2016 Elsevier Inc. All rights reserved.

Platelet von Willebrand factor in Hermansky-Pudlak syndrome.

PubMed

McKeown, L P; Hansmann, K E; Wilson, O; Gahl, W; Gralnick, H R; Rosenfeld, K E; Rosenfeld, S J; Horne, M K; Rick, M E

1998-10-01

The Hermansky-Pudlak Syndrome (HPS) is an autosomal recessive inherited disorder characterized by oculocutaneous albinism, tissue accumulation of ceroid pigment, and a mild to moderate bleeding diathesis attributed to storage-pool deficient (SPD) platlets. Patients have platelet aggregation and release abnormalities. In addition, low levels of plasma von Willebrand factor (vWF) antigen in some HPS patients have been associated with a greater bleeding tendency than would be predicted from either condition alone. Other HPS patients have severe bleeding despite normal levels of plasma vWF, suggesting that at least one additional factor is responsible for their bleeding diathesis. Because platelet vWF levels have been well correlated with clinical bleeding times in patients with von Willebrand's disease, we have measured the platelet vWF activity and antigen levels in 30 HPS patients and have attempted to correlate their clinical bleeding with these values. The platelet vWF activity levels in patients was significantly lower than that of normal subjects (P < 0.0001). The patients as a group also had slightly lower values of plasma vWF activity when compared with normals (P-0.03). In 11 of the HPS patients, the multimeric structure of plasma vWF showed a decrease in the high molecular weight multimers and an increase in the low molecular weight multimers. In correlating the platelet and plasma vWF values with the bleeding histories, we were not able to show a predictable relationship in the majority of the patients.

[Analysis of individualized primary prophylactic treatment of 19 cases of children with severe hemophilia A].

PubMed

Liu, G Q; Tang, L; Wu, X Y; Zhen, Y Z; Li, G; Chen, Z P; Wang, Y; Zhang, N N; Zhang, J S; Yu, G X; Wu, R H

2016-12-02

Objective: To study the current situation of primary prophylaxis in severe hemophilia A children and to explore rational regimen in order to provide evidence for the development of primary prophylaxis in China. Method: A retrospective clinical data collection and analysis was conducted for 19 severe hemophilia A children who received primary prophylaxis in Beijing Children's Hospital outpatient clinic between February 2011 and September 2015 and evaluated the regimen and efficacy. Result: (1) Primary prophylaxis regimen: the median beginning age 1.8 (range 0.5-2.9) years, the median FⅧ preparation using dosage 16.7 (8.0-23.5) U/(kg·time), the median using frequency was 1.0 (1.0-3.0) time/week. Eight cases among the patients received escalation of treatment intensity because of the poor bleeding control. (2) Efficacy: the median annual bleeding rate (ABR) was 1.9 (0-6.0) times/year, the median annual joint bleeding rate (AJBR) was 0 (0-3.3) times/year, without life threatening bleeding. All of them kept in 4th scale of Beijing Children Hospital daily activity level. The median annual factor consumption was 1 844 (840-5 040) U/kg. Conclusion: Low-dose primary prophylaxis regimen which were in low-dose /low frequencies and adjusted by bleeding frequency could decrease bleeding and joint bleeding frequency significantly, maintained the normal daily activity capacity and saved the factor consumption compared to standard regimen in severe hemophilia A children.

Clinical characteristics of Helicobacter pylori-negative drug-negative peptic ulcer bleeding

PubMed Central

Chung, Woo Chul; Jeon, Eun Jung; Kim, Dae Bum; Sung, Hea Jung; Kim, Yeon-Ji; Lim, Eun Sun; Kim, Min-ah; Oh, Jung Hwan

2015-01-01

AIM: To investigate the clinical characteristics and outcomes of idiopathic Helicobacter pylori (H. pylori)-negative and drug-negative] peptic ulcer bleeding (PUB). METHODS: A consecutive series of patients who experienced PUB between 2006 and 2012 was retrospectively analyzed. A total of 232 patients were enrolled in this study. The patients were divided into four groups according to the etiologies of PUB: idiopathic, H. pylori-associated, drug-induced and combined (H. pylori-associated and drug-induced) types. We compared the clinical characteristics and outcomes between the groups. When the silver stain or rapid urease tests were H. pylori-negative, we obtained an additional biopsy specimen by endoscopic re-examination and performed an H. pylori antibody test 6-8 wk after the initial endoscopic examination. For a diagnosis of idiopathic PUB, a negative result of an H. pylori antibody test was confirmed. In all cases, re-bleeding was confirmed by endoscopic examination. For the risk assessment, the Blatchford and the Rockall scores were calculated for all patients. RESULTS: For PUB, the frequency of H. pylori infection was 59.5% (138/232), whereas the frequency of idiopathic cases was 8.6% (20/232). When idiopathic PUB was compared to H. pylori-associated PUB, the idiopathic PUB group showed a higher rate of re-bleeding after initial hemostasis during the hospital stay (30% vs 7.4%, P = 0.02). When idiopathic PUB was compared to drug-induced PUB, the patients in the idiopathic PUB group showed a higher rate of re-bleeding after initial hemostasis upon admission (30% vs 2.7%, P < 0.01). When drug-induced PUB was compared to H. pylori-associated PUB, the patients in the drug-induced PUB were older (68.49 ± 14.76 years vs 47.83 ± 15.15 years, P < 0.01) and showed a higher proportion of gastric ulcer (77% vs 49%, P < 0.01). However, the Blatchford and the Rockall scores were not significantly different between the two groups. Among the patients who experienced drug-induced PUB, no significant differences were found with respect to clinical characteristics, irrespective of H. pylori infection. CONCLUSION: Idiopathic PUB has unique clinical characteristics such as re-bleeding after initial hemostasis upon admission. Therefore, these patients need to undergo close surveillance upon admission. PMID:26229405

Clinical characteristics of Helicobacter pylori-negative drug-negative peptic ulcer bleeding.

PubMed

Chung, Woo Chul; Jeon, Eun Jung; Kim, Dae Bum; Sung, Hea Jung; Kim, Yeon-Ji; Lim, Eun Sun; Kim, Min-Ah; Oh, Jung Hwan

2015-07-28

To investigate the clinical characteristics and outcomes of idiopathic Helicobacter pylori (H. pylori)-negative and drug-negative] peptic ulcer bleeding (PUB). A consecutive series of patients who experienced PUB between 2006 and 2012 was retrospectively analyzed. A total of 232 patients were enrolled in this study. The patients were divided into four groups according to the etiologies of PUB: idiopathic, H. pylori-associated, drug-induced and combined (H. pylori-associated and drug-induced) types. We compared the clinical characteristics and outcomes between the groups. When the silver stain or rapid urease tests were H. pylori-negative, we obtained an additional biopsy specimen by endoscopic re-examination and performed an H. pylori antibody test 6-8 wk after the initial endoscopic examination. For a diagnosis of idiopathic PUB, a negative result of an H. pylori antibody test was confirmed. In all cases, re-bleeding was confirmed by endoscopic examination. For the risk assessment, the Blatchford and the Rockall scores were calculated for all patients. For PUB, the frequency of H. pylori infection was 59.5% (138/232), whereas the frequency of idiopathic cases was 8.6% (20/232). When idiopathic PUB was compared to H. pylori-associated PUB, the idiopathic PUB group showed a higher rate of re-bleeding after initial hemostasis during the hospital stay (30% vs 7.4%, P = 0.02). When idiopathic PUB was compared to drug-induced PUB, the patients in the idiopathic PUB group showed a higher rate of re-bleeding after initial hemostasis upon admission (30% vs 2.7%, P < 0.01). When drug-induced PUB was compared to H. pylori-associated PUB, the patients in the drug-induced PUB were older (68.49 ± 14.76 years vs 47.83 ± 15.15 years, P < 0.01) and showed a higher proportion of gastric ulcer (77% vs 49%, P < 0.01). However, the Blatchford and the Rockall scores were not significantly different between the two groups. Among the patients who experienced drug-induced PUB, no significant differences were found with respect to clinical characteristics, irrespective of H. pylori infection. Idiopathic PUB has unique clinical characteristics such as re-bleeding after initial hemostasis upon admission. Therefore, these patients need to undergo close surveillance upon admission.

Triple antithrombotic therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

PubMed

Kang, Dong Oh; Yu, Cheol Woong; Kim, Hee Dong; Cho, Jae Young; Joo, Hyung Joon; Choi, Rak Kyong; Park, Jin Sik; Lee, Hyun Jong; Kim, Je Sang; Park, Jae Hyung; Hong, Soon Jun; Lim, Do-Sun

2015-08-01

The optimal antithrombotic regimen in patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation for complex coronary artery disease is unclear. We compared the net clinical outcomes of triple antithrombotic therapy (TAT; aspirin, thienopyridine, and warfarin) and dual antiplatelet therapy (DAPT; aspirin and thienopyridine) in AF patients who had undergone DES implantation. A total of 367 patients were enrolled and analyzed retrospectively; 131 patients (35.7%) received TAT and 236 patients (64.3%) received DAPT. DAPT and warfarin were maintained for a minimum of 12 and 24 months, respectively. The primary endpoint was the 2-year net clinical outcomes, a composite of major bleeding and major adverse cardiac and cerebral events (MACCE). Propensity score-matching analysis was carried out in 99 patient pairs. The 2-year net clinical outcomes of the TAT group were worse than those of the DAPT group (34.3 vs. 21.1%, P=0.006), which was mainly due to the higher incidence of major bleeding (16.7 vs. 4.6%, P<0.001), without any significant increase in MACCE (22.1 vs. 17.7%, P=0.313). In the multivariate analysis, TAT was an independent predictor of worse net clinical outcomes (odds ratio 1.63, 95% confidence interval 1.06-2.50) and major bleeding (odds ratio 3.54, 95% confidence interval 1.65-7.58). After propensity score matching, the TAT group still had worse net clinical outcomes and a higher incidence of major bleeding compared with the DAPT group. In AF patients undergoing DES implantation, prolonged administration of TAT may be harmful due to the substantial increase in the risk for major bleeding without any reduction in MACCE.

Effectiveness of a balance training home exercise programme for adults with haemophilia: a pilot study.

PubMed

Hill, K; Fearn, M; Williams, S; Mudge, L; Walsh, C; McCarthy, P; Walsh, M; Street, A

2010-01-01

Adults with haemophilia and other bleeding disorders often develop lower limb musculoskeletal problems associated with bleeds into joints and muscles, which may affect balance performance and increase likelihood of falling. The aim of this study was to evaluate the effectiveness of an individualized balance and strength home exercise programme on improving balance and related outcomes for adults with haemophilia and other bleeding disorders. Twenty male adults with haemophilia and other bleeding disorders (mean age 39.4 years, 95% CI = 33.7-45.1) were recruited to participate. They underwent a comprehensive clinical and force platform assessment of balance and related measures. Based on assessment findings, the assessing physiotherapist provided an individualized home exercise programme of balance, strengthening and walking exercises. Re-assessment occurred after the 4-month exercise programme. Twelve participants (60%) completed the programme and were re-assessed. There were no safety problems or dropouts associated with the exercise programme aggravating joint status. Although there were no statistically significant changes in any of the measures (adjusted for multiple comparisons), there were improvements of between 5% and 22% on 10 of the 16 measures, with the Neurocom modified Clinical Test of Sensory Interaction on Balance (P = 0.036) and Timed Sit to Stand (P = 0.064) approaching significance. A tailored home exercise programme targeting balance, strengthening and walking is feasible for adults with haemophilia and other bleeding disorders. These results suggest that positive physical outcomes including improved balance and mobility may be achieved with this type of programme.

Acute subdural hematoma because of boxing.

PubMed

Kushi, Hidehiko; Saito, Takeshi; Sakagami, Yuichiro; Ohtsuki, Jyoji; Tanjoh, Katsuhisa

2009-02-01

To identify factors determining the clinical characteristics and prognosis of acute subdural hematoma (ASDH) arising from boxing injuries by comparing with ASDH due to any nonboxing cause. Two groups were selected for this study: 10 patients with ASDH because of boxing injuries and 26 patients with nonboxer ASDH. All of the patients underwent neurologic examination by neurosurgeons. Primary resuscitation and stabilization as well as operative therapy were performed to all patients according to the European Brain Injury Consortium Guidelines. Two groups were compared in terms of age, the Glasgow Coma Scale at admission, neurologic findings, craniogram and brain computed tomography scan findings, operative findings, and prognosis. As potential prognostic indicators for boxers, the time interval until surgery, the Glasgow Outcome Scale, hematoma thickness, midline shift, and the site of bleeding were analyzed. The characteristics of patients because of boxing injuries are that patients were younger, had lucid interval, and had no cerebral contusion or contralateral brain injury. There was no significant difference in initial Glasgow Coma Scale, hematoma thickness, midline shift, and their prognosis. The most peculiar clinical presentation of boxers' ASDH was that all bleedings were limited from "bridging veins" or "cortical veins." The prognosis of boxers was most closely correlated with the site of bleeding (r2 = 0.81; p = 0.0001) and the midline shift (r2 = 0.67; p = 0.007). Our study shows that ASDH because of boxing is characterized by bleeding from bridging or cortical veins, and that the site of bleeding is a significant determinant of their prognosis.

Determining the in-hospital cost of bleeding in patients undergoing percutaneous coronary intervention.

PubMed

Ewen, Edward F; Zhao, Liping; Kolm, Paul; Jurkovitz, Claudine; Fidan, Dogan; White, Harvey D; Gallo, Richard; Weintraub, William S

2009-06-01

The economic impact of bleeding in the setting of nonemergent percutaneous coronary intervention (PCI) is poorly understood and complicated by the variety of bleeding definitions currently employed. This retrospective analysis examines and contrasts the in-hospital cost of bleeding associated with this procedure using six bleeding definitions employed in recent clinical trials. All nonemergent PCI cases at Christiana Care Health System not requiring a subsequent coronary artery bypass were identified between January 2003 and March 2006. Bleeding events were identified by chart review, registry, laboratory, and administrative data. A microcosting strategy was applied utilizing hospital charges converted to costs using departmental level direct cost-to-charge ratios. The independent contributions of bleeding, both major and minor, to cost were determined by multiple regression. Bootstrap methods were employed to obtain estimates of regression parameters and their standard errors. A total of 6,008 cases were evaluated. By GUSTO definitions there were 65 (1.1%) severe, 52 (0.9%) moderate, and 321 (5.3%) mild bleeding episodes with estimated bleeding costs of $14,006; $6,980; and $4,037, respectively. When applying TIMI definitions there were 91 (1.5%) major and 178 (3.0%) minor bleeding episodes with estimated costs of $8,794 and $4,310, respectively. In general, the four additional trial-specific definitions identified more bleeding events, provided lower estimates of major bleeding cost, and similar estimates of minor bleeding costs. Bleeding is associated with considerable cost over and above interventional procedures; however, the choice of bleeding definition impacts significantly on both the incidence and economic consequences of these events.

Scoring Systems for Estimating the Risk of Anticoagulant-Associated Bleeding.

PubMed

Parks, Anna L; Fang, Margaret C

2017-07-01

Anticoagulant medications are frequently used to prevent and treat thromboembolic disease. However, the benefits of anticoagulants must be balanced with a careful assessment of the risk of bleeding complications that can ensue from their use. Several bleeding risk scores are available, including the Outpatient Bleeding Risk Index, HAS-BLED, ATRIA, and HEMORR 2 HAGES risk assessment tools, and can be used to help estimate patients' risk for bleeding on anticoagulants. These tools vary by their individual risk components and in how they define and weigh clinical factors. However, it is not yet clear how best to integrate bleeding risk tools into clinical practice. Current bleeding risk scores generally have modest predictive ability and limited ability to predict the most devastating complication of anticoagulation, intracranial hemorrhage. In clinical practice, bleeding risk tools should be paired with a formal determination of thrombosis risk, as their results may be most influential for patients at the lower end of thrombosis risk, as well as for highlighting potentially modifiable risk factors for bleeding. Use of bleeding risk scores may assist clinicians and patients in making informed and individualized anticoagulation decisions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The medical management of abnormal uterine bleeding in reproductive-aged women.

PubMed

Bradley, Linda D; Gueye, Ndeye-Aicha

2016-01-01

In the treatment of women with abnormal uterine bleeding, once a thorough history, physical examination, and indicated imaging studies are performed and all significant structural causes are excluded, medical management is the first-line approach. Determining the acuity of the bleeding, the patient's medical history, assessing risk factors, and establishing a diagnosis will individualize their medical regimen. In acute abnormal uterine bleeding with a normal uterus, parenteral estrogen, a multidose combined oral contraceptive regimen, a multidose progestin-only regimen, and tranexamic acid are all viable options, given the appropriate clinical scenario. Heavy menstrual bleeding can be treated with a levonorgestrel-releasing intrauterine system, combined oral contraceptives, continuous oral progestins, and tranexamic acid with high efficacy. Nonsteroidal antiinflammatory drugs may be utilized with hormonal methods and tranexamic acid to decrease menstrual bleeding. Gonadotropin-releasing hormone agonists are indicated in patients with leiomyoma and abnormal uterine bleeding in preparation for surgical interventions. In women with inherited bleeding disorders all hormonal methods as well as tranexamic acid can be used to treat abnormal uterine bleeding. Women on anticoagulation therapy should consider using progestin-only methods as well as a gonadotropin-releasing hormone agonist to treat their heavy menstrual bleeding. Given these myriad options for medical treatment of abnormal uterine bleeding, many patients may avoid surgical intervention. Copyright © 2016 Elsevier Inc. All rights reserved.

Marked Hypofibrinogenemia and Gastrointestinal Bleeding After Copperhead (Agkistrodon contortrix) Envenomation.

PubMed

Kopec, Kathryn T; Yen, May; Bitner, Matthew; Evans, C Scott; Gerardo, Charles J

2015-12-01

Compared with other crotaline envenomations, copperhead envenomations have historically been reported as having less severe hematologic venom effects and rarely hemorrhage. We report a case of clinically significant gastrointestinal bleeding after a copperhead (Agkistrodon contortrix) envenomation. A 52-year-old woman with a history of systemic lupus erythematosus was bitten on her right medial ankle after which hypofibrinogenemia and hematochezia developed. The symptoms resolved after repeated administration of Crotalidae polyvalent immune Fab (ovine) antivenom. She was discharged without further complications 2 days later. Although copperhead envenomations are classically considered less severe than other crotaline envenomations, this case demonstrates the potential of the venom to produce clinically significant hematologic effects. Copyright © 2015 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Comparison of the Risk of Gastrointestinal Bleeding among Different Statin Exposures with Concomitant Administration of Warfarin: Electronic Health Record-Based Retrospective Cohort Study.

PubMed

Shin, Dahye; Yoon, Dukyong; Lim, Sun Gyo; Hong, Ji Man; Park, Rae Woong; Lee, Jin Soo

2016-01-01

Patients who should be treated with both warfarin and a statin are frequently seen in vascular clinics. The risk for bleeding and potential drug interactions should be considered when prescribing both medications together. This study aimed to compare the risk for gastrointestinal bleeding among different statin exposures with concomitant administration of warfarin. This is a single-hospital retrospective cohort study. We included patients who were concomitantly exposed to one of four statins (pravastatin, simvastatin, atorvastatin, and rosuvastatin) and warfarin for up to 2 years (730 days). The observation period ended when a gastrointestinal bleeding event occurred or the observation was censored. Within-class comparisons were used, and 1:1 matching using a propensity score was performed for comparisons between each statin and all of the other statins. Kaplan-Meier analyses with log-rank tests and Cox proportional hazard regression analyses were conducted to determine associations with the risk of gastrointestinal bleeding. Data were analyzed for 1,686 patients who were concomitantly administered a statin and warfarin. Log-rank tests for the gastrointestinal bleeding-free survival rate showed that the risk for gastrointestinal bleeding was significantly lower in the pravastatin group (p = 0.0499) and higher in the rosuvastatin group (p = 0.009). In the Cox proportional hazard regression analysis, the hazard ratio of 5.394 for gastrointestinal bleeding based on statin exposure in the rosuvastatin group was significant (95% confidence interval, 1.168-24.916). There was a relatively high risk of gastrointestinal bleeding with rosuvastatin when administered concomitantly with warfarin.

Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial.

PubMed

Hamon, Martial; Coste, Pierre; Van't Hof, Arnoud; Ten Berg, Jurrien; Clemmensen, Peter; Tabone, Xavier; Benamer, Hakim; Kristensen, Steen D; Cavallini, Claudio; Marzocchi, Antonio; Hamm, Christian; Kanic, Vojko; Bernstein, Debra; Anthopoulos, Prodromos; Deliargyris, Efthymios N; Steg, Philippe Gabriel

2015-06-01

In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723. © 2015 American Heart Association, Inc.

An automated database case definition for serious bleeding related to oral anticoagulant use.

PubMed

Cunningham, Andrew; Stein, C Michael; Chung, Cecilia P; Daugherty, James R; Smalley, Walter E; Ray, Wayne A

2011-06-01

Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations. The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified inpatient stays during the study period of January 1990 to December 2005 with diagnoses and/or procedures that indicated a current episode of bleeding. The definition was validated by medical record review for a sample of 236 hospitalizations. We reviewed 186 hospitalizations that had medical records with sufficient information for adjudication. Of these, 165 (89%, 95%CI: 83-92%) were clinically confirmed bleeding-related hospitalizations. An additional 19 hospitalizations (10%, 7-15%) were adjudicated as possibly bleeding-related. Of the 165 clinically confirmed bleeding-related hospitalizations, the automated database and clinical definitions had concordant anatomical sites (gastrointestinal, cerebral, genitourinary, other) for 163 (99%, 96-100%). For those hospitalizations with sufficient information to distinguish between upper/lower gastrointestinal bleeding, the concordance was 89% (76-96%) for upper gastrointestinal sites and 91% (77-97%) for lower gastrointestinal sites. A case definition for bleeding-related hospitalizations suitable for automated databases had a positive predictive value of between 89% and 99% and could distinguish specific bleeding sites. Copyright © 2011 John Wiley & Sons, Ltd.

Efficacy and Clinical Outcomes of Transcatheter Arterial Embolization for Gastrointestinal Bleeding from Gastrointestinal Stromal Tumor.

PubMed

Koo, Hyun Jung; Shin, Ji Hoon; Shin, Sooyoung; Yoon, Hyun-Ki; Ko, Gi-Young; Gwon, Dong Il

2015-09-01

To evaluate the efficacy and clinical outcomes of transcatheter arterial embolization (TAE) for gastrointestinal (GI) bleeding from gastrointestinal stromal tumor (GIST). TAE was performed in 20 referred patients (male:female = 13:7; median age, 56.3 y) for GI bleeding from GISTs. The locations of GISTs were assessed using contrast-enhanced computed tomography (CT) and catheter angiography. The technical and clinical success of TAE and clinical outcomes including procedure-related complications, recurrent bleeding, 30-day and overall mortality, and cumulative survival were evaluated. The sites of GIST-related bleeding or tumor staining were the jejunum (n = 9), stomach (n = 5), ileum (n = 3), duodenum (n = 2), and jejunum and colon (n = 1). Angiography showed bleeding from GIST in 5 patients, and tumor staining was noted in only 15 patients. TAE was performed for patients with and without contrast medium extravasation on angiography. Technical and clinical success rates of TAE were 95% (19 of 20 patients) and 90% (18 of 20 patients), respectively. Recurrent bleeding was noted in 1 patient. There were no procedure-related complications. In 15 patients, surgical resection of the tumors was performed after TAE. The 30-day and overall mortality rates were 10% (2 of 20 patients) and 30% (6 of 20 patients), respectively. TAE is a safe and effective method for controlling GI bleeding from the GIST. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

Vorapaxar in atherosclerotic disease management.

PubMed

Cheng, Judy W M; Colucci, Vincent; Howard, Patricia A; Nappi, Jean M; Spinler, Sarah A

2015-05-01

To review the pharmacology, efficacy, and safety of vorapaxar, a protease activator receptor-1 (PAR-1) antagonist, in the management of atherosclerotic diseases. Peer-reviewed clinical trials and review articles were identified from MEDLINE and Current Content database (both 1966 to December 31, 2014) using the search terms vorapaxar and protease activator receptor antagonist. A total of 30 clinical studies were identified (16 clinical trials, including subanalyses, 14 related to pharmacology, pharmacokinetics, and pharmacodynamics and drug interactions). Two phase III clinical trials with vorapaxar have been published. In patients with non-ST segment elevation myocardial infarction (MI), vorapaxar failed to significantly reduce the primary efficacy end point (composite of cardiovascular death, MI, stroke, recurrent ischemia with hospitalization, and urgent coronary revascularization). Conversely, in a study of secondary prevention for patients with cardiovascular disease, the composite end point of cardiovascular death, MI, or stroke was significantly reduced. In both trials, the safety end points of major/minor bleeding were increased compared with placebo. In the secondary prevention trial, an increased incidence of intracranial hemorrhage led to the exclusion of patients with a prior history of stroke. Vorapaxar is approved for use with aspirin and/or clopidogrel in the secondary prevention of cardiovascular events in stable patients with peripheral arterial disease or a history of MI. However, the addition of vorapaxar to other antiplatelets can significantly increase the risk of bleeding. It is, therefore, essential to balance the need for further reduction of risk of thrombotic event with patient's individual bleeding risk. © The Author(s) 2015.

Bleeding Peptic Ulcer - Tertiary Center Experience: Epidemiology, Treatment and Prognosis.

PubMed

Budimir, Ivan; Stojsavljević, Sanja; Hrabar, Davor; Kralj, Dominik; Bišćanin, Alen; Kirigin, Lora Stanka; Zovak, Mario; Babić, Žarko; Bohnec, Sven; Budimir, Ivan

2017-12-01

The aim of this study was to demonstrate epidemiological, clinical and endoscopic characteristics of acute upper gastrointestinal bleeding (UGIB) with special reference to peptic ulcer bleeding (PUB). The study included 2198 consecutive patients referred to our emergency department due to acute UGIB from January 2008 to December 2012. All patients underwent urgent upper GI endoscopy within 24 hours of admission, and 842 patients diagnosed with PUB were enrolled and prospectively followed-up. The cumulative incidence of UGIB was 126/100,000 in the 5-year period. Two out of five patients had a bleeding peptic ulcer; in total, 440 (52.3%) had bleeding gastric ulcer, 356 (42.3%) had bleeding duodenal ulcer, 17 (2%) had both bleeding gastric and duodenal ulcers, and 29 (3.5%) patients had bleeding ulcers on gastroenteric anastomoses. PUB was more common in men. The mean patient age was 65.9 years. The majority of patients (57%) with PUB were taking agents that attenuate the cytoprotective function of gastric and duodenal mucosa. Rebleeding occurred in 77 (9.7%) patients and 47 (5.9%) patients required surgical intervention. The 30-day morality was 5.2% and 10% of patients died from uncontrolled bleeding and concomitant diseases. In conclusion, PUB is the main cause of UGIB, characterized by a significant rebleeding rate and mortality.

Prasugrel versus clopidogrel in patients with acute coronary syndromes.

PubMed

Wiviott, Stephen D; Braunwald, Eugene; McCabe, Carolyn H; Montalescot, Gilles; Ruzyllo, Witold; Gottlieb, Shmuel; Neumann, Franz-Joseph; Ardissino, Diego; De Servi, Stefano; Murphy, Sabina A; Riesmeyer, Jeffrey; Weerakkody, Govinda; Gibson, C Michael; Antman, Elliott M

2007-11-15

Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention. To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding. The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P=0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P=0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P=0.23) and fatal bleeding (0.4% vs. 0.1%; P=0.002). In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591 [ClinicalTrials.gov].) Copyright 2007 Massachusetts Medical Society.

A randomized comparative trial of OTSC and Padlock for upper GI hemostasis in a standardized experimental setting.

PubMed

Prosst, Ruediger L; Kratt, Thomas

2017-04-01

Upper gastrointestinal bleeding (UGIB) is the key emergency situation in clinical endoscopy and is traditionally treated with injection, thermal or through the scope clipping therapy. Mortality rates are in the range of 8-10% and demand new treatment approaches. The Over-The-Scope Clip (OTSC ® ) has been described as a very effective hemostatic device in UGIB. We compared OTSC with the Padlock™ device in an established pre-clinical setting. Our test-bed consisted of the biohybrid EASIE model using soft silicone tubes, tunneled into the gastric wall and surfacing at a mucosa defect, representing the bleeding site. After successful deployment of the OTSC and Padlock devices on the spurting ulcer bleed (Forrest Ia) the vessel tubes were pressurized with a manometer to 120 mmHg. Tight closure at this pressure was defined as successful hemostasis (primary endpoint). N = 11 procedures were done with each device. Statistical testing was done using Fisher's exact test. Sample size was adjusted to an assumed α-error of 5% (two-sided test) and a power of 80%. Technically correct placement of the respective hemostatic device was achieved in all procedures. A statistically significant difference was found in the primary endpoint. In OTSC the success proportion was 100%; 11/11 (95% KI 74.1% to 100%); in Padlock it was 0%; 0/11 (95% KI 0%-25.8%). This means that no bleeding was stopped by Padlock. The mean value of perfusion pressure resistance was 300 mmHg (cut-off) for OTSC and 9.2 ± 8.4 mmHg for Padlock. Our data on hemostatic function of OTSC coincide with the clinical literature and earlier pre-clinical studies in the EASIE model, which is widely accepted as a realistic and effective simulation system for clinical conditions. The inability of Padlock to stop hemorrhage may be due to design differences and, thus, its limitation in providing tight sealing of the clipped tissue. Different types of endoscope-tip mounted clips have different performances. OTSC consistently stops simulated spurting bleeding, Padlock fails to do so. These differences are statistically significant.

Pharmacogenetics-based warfarin dosing algorithm decreases time to stable anticoagulation and the risk of major hemorrhage: an updated meta-analysis of randomized controlled trials.

PubMed

Wang, Zhi-Quan; Zhang, Rui; Zhang, Peng-Pai; Liu, Xiao-Hong; Sun, Jian; Wang, Jun; Feng, Xiang-Fei; Lu, Qiu-Fen; Li, Yi-Gang

2015-04-01

Warfarin is yet the most widely used oral anticoagulant for thromboembolic diseases, despite the recently emerged novel anticoagulants. However, difficulty in maintaining stable dose within the therapeutic range and subsequent serious adverse effects markedly limited its use in clinical practice. Pharmacogenetics-based warfarin dosing algorithm is a recently emerged strategy to predict the initial and maintaining dose of warfarin. However, whether this algorithm is superior over conventional clinically guided dosing algorithm remains controversial. We made a comparison of pharmacogenetics-based versus clinically guided dosing algorithm by an updated meta-analysis. We searched OVID MEDLINE, EMBASE, and the Cochrane Library for relevant citations. The primary outcome was the percentage of time in therapeutic range. The secondary outcomes were time to stable therapeutic dose and the risks of adverse events including all-cause mortality, thromboembolic events, total bleedings, and major bleedings. Eleven randomized controlled trials with 2639 participants were included. Our pooled estimates indicated that pharmacogenetics-based dosing algorithm did not improve percentage of time in therapeutic range [weighted mean difference, 4.26; 95% confidence interval (CI), -0.50 to 9.01; P = 0.08], but it significantly shortened the time to stable therapeutic dose (weighted mean difference, -8.67; 95% CI, -11.86 to -5.49; P < 0.00001). Additionally, pharmacogenetics-based algorithm significantly reduced the risk of major bleedings (odds ratio, 0.48; 95% CI, 0.23 to 0.98; P = 0.04), but it did not reduce the risks of all-cause mortality, total bleedings, or thromboembolic events. Our results suggest that pharmacogenetics-based warfarin dosing algorithm significantly improves the efficiency of International Normalized Ratio correction and reduces the risk of major hemorrhage.

The anticoagulant effects of warfarin and the bleeding risk associated with its use in patients with chronic thromboembolic pulmonary hypertension at a specialist center in Japan: a retrospective cohort study

PubMed Central

Jujo-Sanada, Takayuki; Tanabe, Nobuhiro; Sakao, Seiichiro; Sugiura, Toshihiko; Sekine, Ayumi; Nishimura, Rintaro; Suda, Rika; Naito, Akira; Miwa, Hideki; Yamamoto, Keiko; Sasaki, Akane; Matsumura, Akane; Ema, Ryogo; Kasai, Hajime; Kato, Fumiaki; Tatsumi, Koichiro

2017-01-01

Patients with chronic thromboembolic pulmonary hypertension (CTEPH) require lifelong anticoagulation therapy. However, the bleeding risk and recurrence of venous thromboembolism (VTE) in CTEPH patients who are administered warfarin have not been adequately evaluated. The purpose of this study was to evaluate the risk of clinically relevant bleeding, recurrent VTE, and clinical worsening in patients with CTEPH who were administered warfarin. The clinical records of 72 patients with CTEPH who regularly visited our institution and were administered warfarin were retrospectively reviewed between 1 January 2011 and 31 December 2015. We investigated the incidence of clinically relevant bleeding events, recurrent VTE, and hospitalization for the deterioration of pulmonary hypertension or right heart failure (RHF) during the observation period. The mean observation period for the 72 patients was 3.60 ± 1.60 person-years. Clinically relevant bleeding, RHF, and recurrent VTE occurred in 21 (29.2%), eight (11.1%), and three (4.2%) of 72 patients, respectively, and the incidence rates for these events were 8.1%/person-year, 3.1%/person-year, and 1.2%/person-year, respectively. The incidence rates for the major and non-major bleeding events were 5.0%/person-year and 3.9%/person-year, respectively. The incidence of clinically relevant bleeding events was 20.8%/person-year during medical treatment with a soluble guanylate cyclase stimulator. One of 35 patients (2.9%) during the post-pulmonary endarterectomy period experienced hemoptysis during observation period (> 6 months after pulmonary endarterectomy). No bleeding events occurred during the post-balloon pulmonary angioplasty period. In conclusion, warfarin effectively prevents VTE recurrence in CTEPH patients, but its effects may be associated with a considerable bleeding risk. PMID:28604280

Long-term efficacy of a 0.07% cetylpyridinium chloride mouth rinse in relation to plaque and gingivitis: a 6-month randomized, vehicle-controlled clinical trial.

PubMed

Van Leeuwen, M P C; Rosema, N A M; Versteeg, P A; Slot, D E; Van Winkelhoff, A J; Van der Weijden, G A

2015-05-01

To evaluate the effectiveness of 0.07% cetylpyridinium chloride (CPC) mouth rinse for reduction of gingival inflammation and inhibition of plaque compared to a vehicle control (VC) mouth rinse over a 6-month period. Participants (n = 62) used their randomly assigned product as adjunct to toothbrushing. Bleeding, plaque and staining scores were assessed at baseline, 3 and 6 months. Plaque and saliva samples were taken at each assessment monitoring possible shifts in the composition of the microbiota. A significant difference (P = 0.002) in favour of the CPC mouth rinse, with respect to plaque scores, was found. Bleeding scores at 6 months were not significantly different (P = 0.089). However, when correcting for baseline values, a tendency towards a significant difference in bleeding scores at end trail was observed in favour of the CPC mouth rinse (P = 0.061). Regarding staining at 3 and 6 months, a small but significant difference (8.6% and 10.4%, respectively) (P < 0.0001) was observed with lower scores for the VC group. There was a significant reduction in total anaerobic count in the CPC group at 6 months (P < 0.05). The ratio of aerobes/anaerobes was markedly increased at 3 months, especially in the CPC group. No further differences were observed between groups at 6 months. The use of 0.07% CPC mouth rinse was significantly more effective in reducing plaque scores than the vehicle control. Bleeding scores were not different at 6 months. The test product was well accepted and did not cause any serious clinical side effects or negatively affected the microbiota. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Review: pharmacotherapeutic agents in the treatment of portal hypertension.

PubMed

Lebrec, D

1997-02-01

Certain vasoactive substances reduce portal pressure in patients or animals with portal hypertension by either inducing splanchnic vasoconstriction or reducing hepatic vascular resistance. Studies have shown that propranolol or nadolol significantly reduce the risk of a first episode of gastrointestinal (GI) bleeding and increase the survival rate in patients with cirrhosis and oesophageal varices. Isosorbide-5-mononitrate is also effective in the prevention of bleeding. The combination of beta-blockers and nitrates may be more effective than one drug alone. These results show that beta-adrenoceptor antagonists must be used to prevent the first episode of GI bleeding. Beta-blocker administration also significantly reduces the risk of recurrent GI bleeding and increases the survival rate in patients with cirrhosis. Studies have shown that propranolol is as effective as endoscopic sclerotherapy. The combination of a beta-blocker with endoscopic sclerotherapy may be more effective than pharmacological or endoscopic treatment alone for the prevention of rebleeding. Finally, new experimental and clinical studies are needed to improve the pharmacological treatment of portal hypertension.

Short term clinical effectiveness of a 0.07% cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic appliance treatment

PubMed Central

Pahwa, Narinder; Kumar, Atul; Gupta, Siddharth

2011-01-01

Objectives To test the short term clinical effectiveness of commercially available 0.07%.cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic treatment as compared to a placebo mouth rinse and patients using toothbrush and toothpaste. Method Forty-five subjects for this double blind study were assigned randomly into three groups of 15 each. Gingival inflammation, plaque accumulation, and bleeding on probing, were recorded at baseline (10 days after prophylaxis), and at the end of one month in all the three groups and compared. Results Paired t test showed significant differences in bleeding index for pre and post treatment recordings for cetylpyridinium group. Modified gingival index showed no significant difference in the cetylpyridinium group. For plaque index significant difference was found for cetylpyridinium and control groups. Conclusion Cetylpyridinium mouth rinse 0.7% was found to be effective in reducing the bleeding and plaque index scores. It was not effective in reducing the modified gingival index scores. Cetylpyridinium mouth rinse 0.07% improves the oral hygiene of orthodontic patients when used as an adjunct to normal oral hygiene measures. PMID:23960507

Plaque, gingival bleeding and calculus formation after supragingival scaling with and without polishing: a randomised clinical trial.

PubMed

Zanatta, Fabricio Batistin; Pinto, Tatiana Militz; Kantorski, Karla Zanini; Rösing, Cassiano Kuchenbecker

2011-01-01

The aim of this study was to compare the effect of polishing after scaling and root planing on supragingival plaque, calculus formation, and gingival bleeding. The study was designed as a split-mouth randomised clinical trial. Seventy-six patients were submitted to supragingival scaling on the six mandibular anterior teeth with manual curettes until a smooth surface was achieved. Subsequently, quadrants were randomly selected to be polished (test) or not (control) with a rubber cup and pumice. One, two and three weeks following treatment, a blinded examiner evaluated the visible plaque index, gingival bleeding index and the presence of supragingival calculus on the lingual tooth surfaces. The results showed that unpolished surfaces exhibited higher mean percentages of visible plaque in the third week. No statistically significant differences were observed between unpolished and polished sites related to gingival bleeding. Calculus formation was higher on unpolished sites than on polished sites at 2 and 3 weeks. Dental polishing after supragingival scaling contributed to reducing plaque and calculus formation. Polishing exerts an inhibitory effect on plaque and calculus formation.

Etiological and Endoscopic Profile of Middle Aged and Elderly Patients with Upper Gastrointestinal Bleeding in a Tertiary Care Hospital in North India: A Retrospective Analysis.

PubMed

Mahajan, Pranav; Chandail, Vijant Singh

2017-01-01

Upper gastrointestinal (GI) bleeding is a common medical emergency associated with significant morbidity and mortality. The clinical presentation depends on the amount and location of hemorrhage and the endoscopic profile varies according to different etiology. At present, there are limited epidemiological data on upper GI bleed and associated mortality from India, especially in the middle and elderly age group, which has a higher incidence and mortality from this disease. This study aims to study the clinical and endoscopic profile of middle aged and elderly patients suffering from upper GI bleed to know the etiology of the disease and outcome of the intervention. Out of a total of 1790 patients who presented to the hospital from May 2015 to August 2017 with upper GI bleed, and underwent upper GI endoscopy, data of 1270 patients, aged 40 years and above, was compiled and analyzed retrospectively. All the patients included in the study were above 40 years of age. Majority of the patients were males, with a male to female ratio of 1.6:1. The most common causes of upper GI bleed in these patients were portal hypertension-related (esophageal, gastric and duodenal varices, portal hypertensive gastropathy, and gastric antral vascular ectasia GAVE), seen in 53.62% of patients, followed by peptic ulcer disease (gastric and duodenal ulcers) seen in 17.56% of patients. Gastric erosions/gastritis accounted for 15.20%, and duodenal erosions were seen in 5.8% of upper GI bleeds. The in-hospital mortality rate in our study population was 5.83%. The present study reported portal hypertension as the most common cause of upper GI bleeding, while the most common endoscopic lesions reported were esophageal varices, followed by gastric erosion/gastritis, and duodenal ulcer.

Wireless capsule endoscopy: a comparison with push enteroscopy in patients with gastroscopy and colonoscopy negative gastrointestinal bleeding

PubMed Central

Mylonaki, M; Fritscher-Ravens, A; Swain, P

2003-01-01

Background: The development of wireless capsule endoscopy allows painless imaging of the small intestine. Its clinical use is not yet defined. The aim of this study was to compare the clinical efficacy and technical performance of capsule endoscopy and push enteroscopy in a series of 50 patients with colonoscopy and gastroscopy negative gastrointestinal bleeding. Methods: A wireless capsule endoscope was used containing a CMOS colour video imager, transmitter, and batteries. Approximately 50 000 transmitted images are received by eight abdominal aerials and stored on a portable solid state recorder, which is carried on a belt. Push enteroscopy was performed using a 240 cm Olympus video enteroscope. Results: Studies in 14 healthy volunteers gave information on normal anatomical appearances and preparation. In 50 patients with gastrointestinal bleeding and negative colonoscopy and gastroscopy, push enteroscopy was compared with capsule endoscopy. A bleeding source was discovered in the small intestine in 34 of 50 patients (68%). These included angiodysplasia (16), focal fresh bleeding (eight), apthous ulceration suggestive of Crohn’s disease (three), tumour (two), Meckel’s diverticulum (two), ileal ulcer (one), jejunitis (one), and ulcer due to intussusception (one). One additional intestinal diagnosis was made by enteroscopy. The yield of push enteroscopy in evaluating obscure bleeding was 32% (16/50). The capsule identified significantly more small intestinal bleeding sources than push enteroscopy (p<0.05). Patients preferred capsule endoscopy to push enteroscopy (p<0.001). Conclusions: In this study capsule endoscopy was superior to push enteroscopy in the diagnosis of recurrent bleeding in patients who had a negative gastroscopy and colonoscopy. It was safe and well tolerated. PMID:12865269

[Prevention of gastrointestinal bleeding in patients with advanced burns].

PubMed

Vagner, D O; Krylov, K M; Verbitsky, V G; Shlyk, I V

2018-01-01

To reduce the incidence of gastrointestinal bleeding in patients with advanced burns by developing a prophylactic algorithm. The study consisted of retrospective group of 488 patients with thermal burns grade II-III over 20% of body surface area and prospective group of 135 patients with a similar thermal trauma. Standard clinical and laboratory examination was applied. Instrumental survey included fibrogastroduodenoscopy, endoscopic pH-metry and invasive volumetric monitoring (PICCO plus). Statistical processing was carried out with Microsoft Office Excel 2007 and IBM SPSS 20.0. New algorithm significantly decreased incidence of gastrointestinal bleeding (p<0.001) and mortality rate (p=0.006) in patients with advanced burns.

Microbiological and clinical assessment of the abutment and non-abutment teeth of partial removable denture wearers.

PubMed

Costa, Luciana; do Nascimento, Cássio; de Souza, Valéria Oliveira Pagnano; Pedrazzi, Vinícius

2017-03-01

The aim of this study was assessing the changes in both clinical and microbiological parameters of healthy individuals after rehabilitation with removable partial denture (RPD). 11 women received unilateral or bilateral free-end saddle RPD in the mandibular arch. Clinical and microbiological parameters of abutment, non-abutment, and antagonist teeth were assessed at baseline (RPD installation) and after 7, 30, 90, and 180days of function. The Checkerboard DNA-DNA hybridization technique was used to identify and quantify up to 43 different microbial species from subgingival biofilm samples. Probing depth, gingival recession, and bleeding on probing were also investigated over time. The total and individual microbial genome counts were shown significantly increased after 180days with no significant differences between abutment, non-abutment, or antagonist teeth. Streptococcus spp., Aggregatibacter actinomycetemcomitans, and other species associated to periodontitis (Peptostreptococcus anaerobius, Prevotella nigrescens, and Tannerella forsythia), as well as opportunistic Candida spp., were recovered in moderate counts. Abutment teeth presented higher values of gingival recession when compared with non-abutment or antagonist teeth, irrespectively time of sampling (p<0.05). No significant differences were found between groups regarding bleeding on probing or probing depth over time. Overall, the microbial counts significantly increased after 6 months of denture loading for both abutment and non-abutment teeth with no significant differences regarding the microbial profile over time. Bleeding on probing and probing depth showed no significant difference between groups over time whereas gingival recession increased in the abutment teeth. Copyright © 2016 Elsevier Ltd. All rights reserved.

Risk profile, management, and outcomes of patients with venous thromboembolism attended in Spanish Emergency Departments: The ESPHERIA registry.

PubMed

Jimenez, Sonia; Ruiz-Artacho, Pedro; Merlo, Marta; Suero, Coral; Antolin, Albert; Casal, José Ramón; Sanchez, Marta; Ortega-Duarte, Alejandra; Genis, Mar; Piñera, Pascual

2017-12-01

The objective of this study was to determine the clinical profile of and diagnostic and therapeutic approach to patients with venous thromboembolism (VTE) in Spanish Emergency Departments (EDs). Risk factors, adherence to clinical practice guidelines, and outcomes were also evaluated.Patients with VTE diagnosed in 53 Spanish EDs were prospectively and consecutively included. Demographic data, comorbidities, risk factors for VTE, index event characteristics, hemorrhagic risk, and mortality were evaluated. Adherence to clinical practice guidelines was assessed based on clinical probability scales, requests for determination of D-dimer, use of anticoagulant treatment before confirmation of diagnosis, and assessment of bleeding and prognostic risk. Recurrence, bleeding, and death during admission and at 30, 90, and 180 days after diagnosis in the EDs were recorded.From 549,840 ED visits made over a mean period of 40 days, 905 patients were diagnosed with VTE (incidence 1.6 diagnoses per 1000 visits). The final analysis included 801 patients, of whom 49.8% had pulmonary embolism. The most frequent risk factors for VTE were age (≥70 years), obesity, and new immobility. Clinical probability, prognosis, and bleeding risk scales were recorded in only 7.6%, 7.5%, and 1% of cases, respectively. D-dimer was determined in 87.2% of patients with a high clinical probability of VTE, and treatment was initiated before confirmation in only 35.9% of these patients. In patients with pulmonary embolism, 31.3% had a low risk of VTE. Overall, 98.7% of patients with pulmonary embolism and 50.2% of patients with deep venous thrombosis were admitted. During follow-up, total bleeding was more frequent than recurrences: the rates of any bleeding event were 4.4%, 3.9%, 5.3%, and 3.5% at admission and at 30 and 90, and 180 days, respectively; the rates of VTE recurrence were 2.3%, 1.3%, 1.7%, and 0.6%, respectively. Mortality rates were 3.4%, 3.1%, 4.1%, and 2.6% during hospitalization and at 30, 90, and 180 days, respectively.VTE had a substantial impact on Spanish EDs. The clinical presentation and risk profile for the development of VTE in patients diagnosed in the EDs was similar to that recorded in previous studies. During follow-up, bleeding (overall) was more frequent than recurrences. Adherence to clinical practice guidelines could improve significantly.

The Clinical Outcomes of Lower Gastrointestinal Bleeding Are Not Better than Those of Upper Gastrointestinal Bleeding.

PubMed

Kwak, Min Seob; Cha, Jae Myung; Han, Yong Jae; Yoon, Jin Young; Jeon, Jung Won; Shin, Hyun Phil; Joo, Kwang Ro; Lee, Joung Il

2016-10-01

The incidence of lower gastrointestinal bleeding (LGIB) is increasing; however, predictors of outcomes for patients with LGIB are not as well defined as those for patients with upper gastrointestinal bleeding (UGIB). The aim of this study was to identify the clinical outcomes and the predictors of poor outcomes for patients with LGIB, compared to outcomes for patients with UGIB. We identified patients with LGIB or UGIB who underwent endoscopic procedures between July 2006 and February 2013. Propensity score matching was used to improve comparability between LGIB and UGIB groups. The clinical outcomes and predictors of 30-day rebleeding and mortality rate were analyzed between the two groups. In total, 601 patients with UGIB (n = 500) or LGIB (n = 101) were included in the study, and 202 patients with UGIB and 101 patients with LGIB were analyzed after 2:1 propensity score matching. The 30-day rebleeding and mortality rates were 9.9% and 4.5% for the UGIB group, and 16.8% and 5.0% for LGIB group, respectively. After logistic regression analysis, the Rockall score (P = 0.013) and C-reactive protein (CRP; P = 0.047) levels were significant predictors of 30-day mortality in patients with LGIB; however, we could not identify any predictors of rebleeding in patients with LGIB. The clinical outcomes for patients with LGIB are not better than clinical outcomes for patients with UGIB. The clinical Rockall score and serum CRP levels may be used to predict 30-day mortality in patients with LGIB.

The efficacy of tranexamic acid and corticosteroid on edema and ecchymosis in septorhinoplasty.

PubMed

Sakallioğlu, Öner; Polat, Cahit; Soylu, Erkan; Düzer, Sertaç; Orhan, İsrafil; Akyiğit, Abdulvahap

2015-04-01

The aim of this study was to investigate the efficacy of tranexamic acid (TA) and methylprednisolone on periorbital edema, ecchymosis, and intraoperative bleeding in patients who underwent open septorhinoplasty (oSRP). Seventy-five patients performing hump extraction and osteotomies were allocated into 3 groups as follows: group 1, 25 patients as control; group 2, 25 patients who were administered oral TA as first dose 1 g starting 2 hours before surgery, 3 g daily in divided doses (1 g, every 8 hours) for 5 days; and group 3, 25 patients who were administered a single dose of 1 mg/kg intravenous methylprednisolone at the beginning of the surgery. Operation time, amount of intraoperative bleeding, and complications were recorded. Scoring of eyelid edema and periorbital ecchymosis was evaluated on postoperative first, third, and seventh days using scale of 0 to 4 by 2 observers. In groups using TA and methylprednisolone, periorbital edema and ecchymosis scores were significantly lower compared with the control group (P < 0.05). No significant difference was seen clinically and statistically in preventing or decreasing both periorbital edema and ecchymosis between group 2 and group 3. Patients given TA showed significantly less intraoperative bleeding compared with controls and patients who were administered methylprednisolone. We observed that the administration of methylprednisolone significantly decreases periorbital edema and ecchymosis. Additionally, our results support that TA use in patients who underwent oSRP with osteotomies was found clinically and statistically effective for prevention of bleeding during oSRP operations and reduction of both periorbital edema and ecchymosis.

Abnormal Uterine Bleeding Is Associated With Increased BMP7 Expression in Human Endometrium.

PubMed

Richards, Elliott G; El-Nashar, Sherif A; Schoolmeester, John K; Keeney, Gary L; Mariani, Andrea; Hopkins, Matthew R; Dowdy, Sean C; Daftary, Gaurang S; Famuyide, Abimbola O

2017-05-01

Abnormal uterine bleeding (AUB), a common health concern of women, is a heterogeneous clinical entity that is traditionally categorized into organic and nonorganic causes. Despite varied pharmacologic treatments, few offer sustained efficacy, as most are empiric, unfocused, and do not directly address underlying dysregulated molecular mechanisms. Characterization of such molecular derangements affords the opportunity to develop and use novel, more successful treatments for AUB. Given its implication in other organ systems, we hypothesized that bone morphogenetic protein (BMP) expression is altered in patients with AUB and hence comprehensively investigated dysregulation of BMP signaling pathways by systematically screening 489 samples from 365 patients for differences in the expression of BMP2, 4, 6, and 7 ligands, BMPR1A and B receptors, and downstream SMAD4, 6, and 7 proteins. Expression analysis was correlated clinically with data abstracted from medical records, including bleeding history, age at procedure, ethnicity, body mass index, hormone treatment, and histological diagnosis of fibroids, polyps, adenomyosis, hyperplasia, and cancer. Expression of BMP7 ligand was significantly increased in patients with AUB (H-score: 18.0 vs 26.7; P < .0001). Patients reporting heavy menstrual bleeding (menorrhagia) as their specific AUB pattern demonstrated significantly higher BMP7 expression. Significantly, no differences in the expression of any other BMP ligands, receptors, or SMAD proteins were observed in this large patient cohort. However, expression of BMPR1A, BMPR1B, and SMAD4 was significantly decreased in cancer compared to benign samples. Our study demonstrates that BMP7 is a promising target for future investigation and pharmacologic treatment of AUB.

Risky Sexual Behavior, Bleeding Caused by Intimate Partner Violence, and Hepatitis C Virus Infection in Patients of a Sexually Transmitted Disease Clinic

PubMed Central

Chen, Meng-Jinn; Nochajski, Thomas H.; Testa, Maria; Zimmerman, Scott J.; Hughes, Patricia S.

2009-01-01

Objectives. We sought to investigate independent contributions of risky sexual behaviors and bleeding caused by intimate partner violence to prediction of HCV infection. Methods. We conducted a case–control study of risk factors among patients of a sexually transmitted disease clinic with and without HCV antibodies, group-matched by age. Results. Multivariate analyses indicated that Black race (odds ratio [OR] = 2.4; 95% confidence interval [CI] = 1.3, 4.4), injection drug use (OR = 20.3; 95% CI = 10.8, 37.8), sharing straws to snort drugs (OR = 1.8; 95% CI = 1.01, 3.0), sharing razors (OR = 7.8; 95% CI = 2.0, 31.0), and exposure to bleeding caused by intimate partner violence (OR = 5.5; 95% CI = 1.4, 22.8) contributed significantly to the prediction of HCV infection; risky sexual behavior and exposure to blood or sores during sexual intercourse did not. Conclusions. HCV risk among patients of a sexually transmitted disease clinic can be explained by direct blood exposure, primarily through injection drug use. Exposure to bleeding caused by intimate partner violence may be a previously unrecognized mechanism for HCV transmission associated with risky sexual behavior. PMID:19218181

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

The model for the end-stage liver disease and Child-Pugh score in predicting prognosis in patients with liver cirrhosis and esophageal variceal bleeding.

PubMed

Benedeto-Stojanov, Daniela; Nagorni, Aleksandar; Bjelaković, Goran; Stojanov, Dragan; Mladenović, Bojan; Djenić, Nebojsa

2009-09-01

Esophageal variceal bleeding is one of the most frequent and gravest complications of liver cirrhosis, directly life-threatening. By monitoring certain clinical and laboratory hepatocellular insufficiency parameters (Child-Pugh score), it is possible to determine prognosis in patients who are bleeding and evaluate further therapy. Recently, the Model for the End-Stage Liver Disease (MELD) has been proposed as a tool to predict mortality risk in cirrhotic patients. The aim of the study was to evaluate survival prognosis of cirrhotic patients by the MELD and Child-Pugh scores and to analyze the MELD score prognostic value in patients with both liver cirrhosis and variceal bleeding. We retrospectively evaluated the survival rate of a group of 100 cirrhotic patients of a median age of 57 years. The Child-Pugh score was calculated and the MELD score was computed according to the original formula for each patient. We also analysed clinical and laboratory hepatocellular insufficiency parameters in order to examine their connection with a 15-month survival. The MELD values were correlated with the Child-Pugh scores. The Student's t-test was used for statistical analysis. Twenty-two patients died within 15-months followup. Age and gender did not affect survival rate. The Child-Pugh and MELD scores, as well as ascites and encephalopathy significantly differed between the patients who survived and those who died (p < 0.0001). The International Normalized Ratio (INR) values, serum creatinine and bilirubin were significantly higher, and albumin significantly lower in the patients who died (p < 0.0001). The MELD score was significantly higher in the group of patients who died due to esophageal variceal bleeding (p < 0.0001). In cirrhotic patients the MELD score is an excellent survival predictor at least as well as the Child-Pugh score. Increase in the MELD score is associated with decrease in residual liver function. In the group of patients with liver cirrhosis and esophageal variceal bleeding, the MELD score identifies those with a higher intrahospital mortality risk.

Outpatient application of formalin for chronic rectal bleeding after prostate irradiation: a quasi-experimental study.

PubMed

Viani, Gustavo Arruda; Sakamoto, Aline

2017-07-01

The aim of this quasi-experimental study is to evaluate a novel technique for an outpatient application of formalin for chronic rectal bleeding after prostate irradiation. This is a quasi- experimental clinical trial developed between January 2010 and July 2015, including 35 patients with chronic radiation rectitis (CRP) due to a previous prostate radiation course. The study's eligibility was (1) completed external beam radiation therapy for prostate carcinoma >6 months previously, (2) rectal bleeding, defined as a frequency of >1× per week and/or needing of blood transfusions, and (3) diagnosis of chronic proctitis at colonoscopy. The 5% formalin application was performed by a custom applicator, which requires neither anesthesia nor sigmoidoscopy. The endpoint of the study was bleeding cessation and hemoglobin level. The onset of bleeding due to chronic rectitis was 12 months (6-36). During a median follow-up of 24 months, the rate of overall efficacy was 94%. The sustained complete response in 1 and 2 years was 80% and 73%, respectively. The Hb mean pre- and post-treatment differed significantly (12.2 vs 14.4, p = 0.0001). The rates of blood transfusion differed significantly, pre- and post-treatment (17% vs 5.7%, p = 0.031). The technique is very effective and safe, resulting to a significant improvement of hemoglobin levels and quality of life scores. Further studies are warranted to compare this technique with other treatment options for chronic radiation-induced rectal bleeding.

Risk Factors Associated with Mortality and Increased Drug Costs in Nonvariceal Upper Gastrointestinal Bleeding.

PubMed

Lu, Mingliang; Sun, Gang; Zhang, Xiu-li; Zhang, Xiao-mei; Liu, Qing-sen; Huang, Qi-yang; Lau, James W Y; Yang, Yun-sheng

2015-06-01

To determine risk factors associated with mortality and increased drug costs in patients with nonvariceal upper gastrointestinal bleeding. We retrospectively analyzed data from patients hospitalized with nonvariceal upper gastrointestinal bleeding between January 2001-December 2011. Demographic and clinical characteristics and drug costs were documented. Univariate analysis determined possible risk factors for mortality. Statistically significant variables were analyzed using a logistic regression model. Multiple linear regression analyzed factors influencing drug costs. p < 0.05 was considered statistically significant. The study included data from 627 patients. Risk factors associated with increased mortality were age > 60, systolic blood pressure<100 mmHg, lack of endoscopic examination, comorbidities, blood transfusion, and rebleeding. Drug costs were higher in patients with rebleeding, blood transfusion, and prolonged hospital stay. In this patient cohort, re-bleeding rate is 11.20% and mortality is 5.74%. The mortality risk in patients with comorbidities was higher than in patients without comorbidities, and was higher in patients requiring blood transfusion than in patients not requiring transfusion. Rebleeding was associ-ated with mortality. Rebleeding, blood transfusion, and prolonged hospital stay were associated with increased drug costs, whereas bleeding from lesions in the esophagus and duodenum was associated with lower drug costs.

Efficacy and safety of the low-molecular weight heparin enoxaparin compared with unfractionated heparin across the acute coronary syndrome spectrum: a meta-analysis.

PubMed

Murphy, Sabina A; Gibson, Charles Michael; Morrow, David A; Van de Werf, Frans; Menown, Ian B; Goodman, Shaun G; Mahaffey, Kenneth W; Cohen, Marc; McCabe, Carolyn H; Antman, Elliott M; Braunwald, Eugene

2007-09-01

To determine whether the low-molecular weight heparin enoxaparin remains favourable when compared with unfractionated heparin (UFH) among patients with acute coronary syndromes (ACS) when incorporating efficacy and safety of these adjunctive therapies using a net clinical endpoint. We performed a meta-analysis of randomized trials of enoxaparin vs. UFH in ST-elevation-MI (STEMI) or non-ST-elevation-ACS (NSTEACS) (n = 49,088 patients in 12 trials). The net clinical endpoint was defined as death, MI, or major bleeding by 30 days. Death or myocardial infarction (MI) was significantly reduced with enoxaparin when compared with UFH (9.8 vs. 11.4%, OR 0.84, P < 0.001). The net clinical endpoint occurred less frequently with enoxaparin than UFH (12.5 vs. 13.5%, OR 0.90, P = 0.051). Major bleeding was higher with enoxaparin (4.3 vs. 3.4%, OR 1.25, P = 0.019). Among STEMI trials, the net clinical endpoint was significantly lower with enoxaparin (OR 0.84, P = 0.015), but there was no difference in NSTEACS trials (OR 0.97). When compared with UFH, enoxaparin was associated with superior efficacy as adjunctive antithrombin therapy among >49 000 patients across the ACS spectrum. Although bleeding was increased with enoxaparin, this increase was offset by a reduction in death or MI. The net clinical benefit in favour of enoxaparin was evident among the STEMI population and was neutral among the NSTEACS population.

The influence of residual apixaban on bleeding complications during and after catheter ablation of atrial fibrillation.

PubMed

Mukai, Yutaro; Wada, Kyoichi; Miyamoto, Koji; Nakagita, Kazuki; Fujimoto, Mai; Hosomi, Kouichi; Kuwahara, Takeshi; Takada, Mitsutaka; Kusano, Kengo; Oita, Akira

2017-10-01

The periprocedural protocol for atrial fibrillation (AF) ablation commonly includes anticoagulation therapy. Apixaban, a direct oral anticoagulant, is currently approved for clinical use; however, little is known about the effects of residual apixaban concentration on bleeding complications during/after AF ablation. Therefore, we measured residual apixaban concentration by using mass spectrometry and examined the anticoagulant's residual effects on bleeding complications. Fifty-eight patients (Mean age of 64.7±12.5 years; 31 males, 27 females) were enrolled and administered apixaban twice daily. We analyzed trough apixaban concentration, activated clotting time (ACT), heparin dose, and bleeding complications during/after AF ablation. Apixaban concentrations were directly measured using mass spectrometry. Bleeding complications were observed in 19 patients (delayed hemostasis at the puncture site, 16; hematuria, 3; hemosputum, 1). No patient required blood transfusion. The mean trough apixaban concentration was significantly lower in patients with bleeding complications than without (152.4±73.1 vs. 206.8±98.8 ng/mL respectively, P =0.037), while the heparin dose to achieve ACT>300 s was significantly higher in patients with bleeding complications (9368.4±2929.0 vs. 7987.2±2135.2 U/body respectively, P =0.046). Interestingly, a negative correlation was found between the trough apixaban concentration and the heparin dose to achieve ACT>300 s ( P =0.033, R=-0.281). Low residual plasma apixaban is associated with a higher incidence of bleeding complications during/after AF ablation, potentially because of a greater heparin requirement during AF ablation.

Clinical presentation and course of bleeding events in patients with venous thromboembolism, treated with apixaban or enoxaparin and warfarin. Results from the AMPLIFY trial.

PubMed

Bleker, Suzanne M; Cohen, Alexander T; Büller, Harry R; Agnelli, Giancarlo; Gallus, Alexander S; Raskob, Gary E; Weitz, Jeffrey I; Curto, Madelyn; Sisson, Melanie; Middeldorp, Saskia

2016-11-30

Apixaban, a direct acting oral anticoagulant (DOAC), was found to be non-inferior to and safer as enoxaparin followed by warfarin for treatment of venous thromboembolism (VTE) in the AMPLIFY trial. Information is needed on how bleeding events with DOACs present and develop. In this post-hoc analysis, the clinical presentation and course of all major and clinically relevant non major (CRNM) bleeding events in the AMPLIFY trial were blindly classified by three investigators, using pre-designed classification schemes containing four categories. Odds ratios (OR) for classifying as category three or four (representing a more severe clinical presentation and course) were calculated between apixaban and enoxaparin/warfarin. In total, 63 major and 311 CRNM bleeding events were classified. Of the major bleeds, a more severe clinical presentation occurred in 28.5 % of apixaban versus 44.9 % of enoxaparin/warfarin related recipients (OR 0.49, 95 % confidence interval [CI] 0.14-1.78). A severe clinical course was observed in 14.3 % and in 12.2 %, respectively (OR 1.19, 95 %CI 0.21-6.69). Of the CRNM bleeding events, a more severe clinical presentation and extent of clinical care was found in 25 % of apixaban recipients compared to 22.7 % in the enoxaparin/warfarin group (OR 1.13, 95 %CI 0.65-1.97). The clinical presentation and course of major and CRNM bleeds were similar in apixaban and enoxaparin/warfarin treated patients. This finding should reassure physicians and patients that even in the absence of a specific reversal agent, apixaban is a convenient and safe choice for VTE.

Intra-Arterial Treatment in Patients with Acute Massive Gastrointestinal Bleeding after Endoscopic Failure: Comparisons between Positive versus Negative Contrast Extravasation Groups

PubMed Central

Chang, Wei-Chou; Liu, Chang-Hsien; Hsu, Hsian-He; Huang, Guo-Shu; Tung, Ho-Jui; Hsieh, Tsai-Yuan; Tsai, Shih-Hung; Hsieh, Chung-Bao

2011-01-01

Objective To determine whether treatment outcome is associated with visualization of contrast extravasation in patients with acute massive gastrointestinal bleeding after endoscopic failure. Materials and Methods From January 2007 to December 2009, patients that experienced a first attack of acute gastrointestinal bleeding after failure of initial endoscopy were referred to our interventional department for intra-arterial treatment. We enrolled 79 patients and divided them into two groups: positive and negative extravasation. For positive extravasation, patients were treated by coil embolization; and in negative extravasation, patients were treated with intra-arterial vasopressin infusion. The two groups were compared for clinical parameters, hemodynamics, laboratory findings, endoscopic characteristics, and mortality rates. Results Forty-eight patients had detectable contrast extravasation (positive extravasation), while 31 patients did not (negative extravasation). Fifty-six patients survived from this bleeding episode (overall clinical success rate, 71%). An elevation of hemoglobin level was observed in the both two groups; significantly greater in the positive extravasation group compared to the negative extravasation group. Although these patients were all at high risk of dying, the 90-day mortality rate was significantly lower in the positive extravasation than in the negative extravasation (20% versus 42%, p < 0.05). A multivariate analysis suggested that successful hemostasis (odds ratio [OR] = 28.66) is the most important predictor affecting the mortality in the two groups of patients. Conclusion Visualization of contrast extravasation on angiography usually can target the bleeding artery directly, resulting in a higher success rate to control of hemorrhage. PMID:21927558

Interventional Algorithms for the Control of Coagulopathic Bleeding in Surgical, Trauma, and Postpartum Settings

PubMed Central

Rodrigues, Anabela; Gomes, Manuela; Carrilho, Alexandre; Nunes, António Robalo; Orfão, Rosário; Alves, Ângela; Aguiar, José; Campos, Manuel

2014-01-01

Several clinical settings are associated with specific coagulopathies that predispose to uncontrolled bleeding. With the growing concern about the need for optimizing transfusion practices and improving treatment of the bleeding patient, a group of 9 Portuguese specialists (Share Network Group) was created to discuss and develop algorithms for the clinical evaluation and control of coagulopathic bleeding in the following perioperative clinical settings: surgery, trauma, and postpartum hemorrhage. The 3 algorithms developed by the group were presented at the VIII National Congress of the Associação Portuguesa de Imuno-hemoterapia in October 2013. They aim to provide a structured approach for clinicians to rapidly diagnose the status of coagulopathy in order to achieve an earlier and more effective bleeding control, reduce transfusion requirements, and improve patient outcomes. The group highlights the importance of communication between different specialties involved in the care of bleeding patients in order to achieve better results. PMID:25424528

Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel.

PubMed

Funk, Sidney; Miller, Michael M; Mishell, Daniel R; Archer, David F; Poindexter, Alfred; Schmidt, Juergen; Zampaglione, Edio

2005-05-01

The safety and efficacy of a single-rod implantable contraceptive containing etonogestrel (Implanontrade mark) were investigated in a multicenter clinical trial. Sexually active American women (N=330) with apparently normal menstrual cycles used the implant for up to 2 years. All subjects recorded bleeding and/or spotting daily in a diary. Safety was assessed through adverse experiences (AEs), laboratory tests and physical and gynecologic examinations. Total exposure was 474 woman-years (6186 cycles), and 68% of subjects had at least 1 year of exposure. No pregnancies occurred. The most common bleeding pattern observed throughout the study was infrequent bleeding, defined as less than three episodes of bleeding in a reference period (excluding amenorrhea). The least common pattern was frequent bleeding, defined as more than five episodes of bleeding in a reference period. Infrequent, prolonged and frequent bleeding patterns were most common early in the study and declined thereafter. During the 3-month Reference Periods 2-8 (Months 4-24), the incidence of amenorrhea ranged from 14% to 20%. Forty-three subjects (13%) withdrew from the study because of bleeding pattern changes and 76 subjects (23%) discontinued because of other AEs. Other common AEs leading to discontinuation, besides bleeding irregularities, were emotional lability (6.1%), weight increase (3.3%), depression (2.4%) and acne (1.5%). Use of Implanon (etonogestrel subdermal implant, referred to herein as ENG implant) for up to 2 years had no clinically significant effects on laboratory parameters, physical and pelvic examinations, vital signs or body mass index. The average length of time required for ENG implant insertion and that for removal were 0.5 and 3.5 min, respectively, and all the procedures were uncomplicated. The return to normal menstrual cycles and fertility was rapid after removal. Implanon is a safe, highly effective and rapidly reversible new method of contraception.

ACR Appropriateness Criteria® Nonvariceal Upper Gastrointestinal Bleeding.

PubMed

Singh-Bhinder, Nimarta; Kim, David H; Holly, Brian P; Johnson, Pamela T; Hanley, Michael; Carucci, Laura R; Cash, Brooks D; Chandra, Ankur; Gage, Kenneth L; Lambert, Drew L; Levy, Angela D; Oliva, Isabel B; Peterson, Christine M; Strax, Richard; Rybicki, Frank J; Dill, Karin E

2017-05-01

Upper gastrointestinal bleeding (UGIB) remains a significant cause of morbidity and mortality with mortality rates as high as 14%. This document addresses the indications for imaging UGIB that is nonvariceal and unrelated to portal hypertension. The four variants are derived with respect to upper endoscopy. For the first three, it is presumed that upper endoscopy has been performed, with three potential initial outcomes: endoscopy reveals arterial bleeding source, endoscopy confirms UGIB without a clear source, and negative endoscopy. The fourth variant, "postsurgical and traumatic causes of UGIB; endoscopy contraindicated" is considered separately because upper endoscopy is not performed. When endoscopy identifies the presence and location of bleeding but bleeding cannot be controlled endoscopically, catheter-based arteriography with treatment is an appropriate next study. CT angiography (CTA) is comparable with angiography as a diagnostic next step. If endoscopy demonstrates a bleed but the endoscopist cannot identify the bleeding source, angiography or CTA can be typically performed and both are considered appropriate. In the event of an obscure UGIB, angiography and CTA have been shown to be equivalent in identifying the bleeding source; CT enterography may be an alternative to CTA to find an intermittent bleeding source. In the postoperative or traumatic setting when endoscopy is contraindicated, primary angiography, CTA, and CT with intravenous contrast are considered appropriate. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Clinical predictors and gender-wise variations in dyssynergic defecation disorders.

PubMed

Jain, Mayank; Baijal, Rajiv; Srinivas, Melpakkam; Venkataraman, Jayanthi

2018-06-12

There is insufficient data from India regarding clinical predictors of dyssynergic defecation. To identify demography, symptom, and colonoscopic parameters that can predict dyssynergic defecation (DD) among patients with chronic constipation (CC) and to compare the profile among male and female patients with DD. Data collected from three centers during June 2014 to May 2017 included age, gender, symptom duration, form and consistency of stools, digital examination, colonoscopy, and anorectal manometry (ARM). Patients were grouped based on ARM diagnosis: group I (normal study) and group II (DD). The two groups were compared for demography, symptom profile, and colonoscopy findings. Gender-wise subset analysis was done for those with the normal and abnormal ARM using chi-square and unpaired t tests. Of 236 patients with CC evaluated, 130 (55%) had normal ARM and 106 (45%) had DD. Male sex, straining during defecation, bleeding per rectum, and abnormal colonoscopic diagnosis were significantly more common in group II. While bleeding per rectum and absence of urge to defecate were more common in males (p < 0.02), straining, digital evacuation, and hard stools were commoner in females with DD. Straining during defecation, bleeding per rectum, and abnormal colonoscopy findings were more common in patients with DD. Symptoms of bleeding per rectum and absence of urge to defecate in men and straining during defecation in female patients were significantly associated with DD. Symptoms differ in males and females with DD.

A randomized controlled study comparing omeprazole and cimetidine for the prophylaxis of stress-related upper gastrointestinal bleeding in patients with intracerebral hemorrhage.

PubMed

Liu, Bo-lin; Li, Bing; Zhang, Xiang; Fei, Zhou; Hu, Shi-jie; Lin, Wei; Gao, Da-kuan; Zhang, Li

2013-01-01

Patients with intracerebral hemorrhage (ICH) are at high risk for severe stress-related upper gastrointestinal (UGI) bleeding, which is predictive of higher mortality. The aim of this study was to evaluate the effectiveness of omeprazole and cimetidine compared with a placebo in the prevention and management of stress-related UGI bleeding in patients with ICH. In a single-center, randomized, placebo-controlled study, 184 surgically treated patients with CT-proven ICH within 72 hours of ictus and negative results for gastric occult blood testing were included. Of these patients, 165 who were qualified upon further evaluation were randomized into 3 groups: 58 patients received 40 mg intravenous omeprazole every 12 hours, 54 patients received 300 mg intravenous cimetidine every 6 hours, and 53 patients received a placebo. Patients whose gastric occult blood tests were positive at admission (n = 70) and during/after the prophylaxis procedure (n = 48) were treated with high-dose omeprazole at 80 mg bolus plus 8 mg/hr infusion for 3 days, followed by 40 mg intravenous omeprazole every 12 hours for 7 days. Of the 165 assessable patients, stress-related UGI bleeding occurred in 9 (15.5%) in the omeprazole group compared with 15 patients (27.8%) in the cimetidine group and 24 patients (45.3%) in the placebo group (p = 0.003). The occurrence of UGI bleeding was significantly related to death (p = 0.022). Nosocomial pneumonia occurred in 14 patients (24.1%) receiving omeprazole, 12 (22.2%) receiving cimetidine, and 8 (15.1%) receiving placebo (p > 0.05). In patients with UGI bleeding in which high-dose omeprazole was initiated, UGI bleeding arrested within the first 3 days in 103 patients (87.3%). Omeprazole significantly reduced the morbidity of stress-related UGI bleeding in patients with ICH due to its effective prophylactic effect without increasing the risk of nosocomial pneumonia, but it did not reduce the 1-month mortality or ICU stay. Further evaluation of high-dose omeprazole as the drug of choice for patients presenting with UGI bleeding is warranted. Clinical trial registration no.: ChiCTR-TRC-12001871, registered at the Chinese clinical trial registry (http://www.chictr.org/en/proj/show.aspx?proj=2384).

Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial

PubMed Central

Tavakoli, Nader; Agah, Shahram; Azizi, Ali; Masoodi, Mohsen; Amiri, Hassan; Sheikhvatan, Mehrdad; Syedsalehi, Bahare; Behnam, Behdad; Arabahmadi, Mehran; Mehrazi, Maryam

2017-01-01

Background Tranexamic acid (TXA), a synthetic antifibrinolytic drug, is effective as a treatment for serious hemorrhage, including bleeding arising from major trauma and post-operative interventions. Significant acute gastrointestinal bleeding may have a poor outcome despite routine medical and endoscopic treatments. The aim of this study was to assess whether early intravenous and/or intravenous plus topical administration of TXA reduces the need for urgent endoscopy for acute gastrointestinal bleeding. Method This double-blind randomized clinical trial included 410 patients with proven acute gastrointestinal bleeding. All patients received conventional therapy. The subjects were randomized to three groups: (A) 138 patients received intravenous TXA (1 g q6h); (B) 133 patients received topical TXA (1 g single dose by nasogastric tube) plus systemic TXA; and (C) 139 patients received a placebo (sodium chloride 0.9%) for 24 hours. Subgroup statistical analyses were conducted for urgent endoscopy, mortality, re-bleeding, blood transfusion, endoscopic and/or surgical intervention rates, and health status. Results The time to endoscopy was significantly shorter in group C (15.58 ± 7.994, p < 0.001). A need for urgent endoscopy was seen in 14.49%, 10.52%, and 30.21% of patients in groups A, B, and C, respectively (p < 0.001). No significant statistical differences were seen between treatment groups regarding mortality, re-bleeding, blood transfusion, and endoscopic and/or surgical intervention rates. No thromboembolic event was documented during the 1-week follow up. Conclusions Our results showed that the antifibrinolytic properties of TXA can aid in changing an urgent endoscopy to an elective procedure, with better outcomes for both physicians and patients. PMID:29435313

Examining the bleeding incidences associated with targeted therapies used in metastatic renal cell carcinoma.

PubMed

Crist, MacKenzie; Hansen, Elizabeth; Chablani, Lipika; Guancial, Elizabeth

2017-12-01

A systematic review was conducted to illustrate the bleeding risks associated with targeted therapies used in the treatment of metastatic renal cell carcinoma (mRCC). Eligible studies included phase II, III, or IV clinical trials using pazopanib, sunitinib, cabozantinib, lenvatinib, everolimus, temsirolimus, bevacizumab, axitinib, and/or sorafenib in the setting of mRCC. Types of bleeding event(s), bleeding event frequency, and incidence of thrombocytopenia were collected from the relevant articles. ClinicalTrials.gov was also searched for incidence of "Serious bleeding adverse effects" reported in these trials. The incidences of bleeding events ranged from 1 to 36%, and incidences of thrombocytopenia ranged from 2 to 78%. Available serious bleeding adverse events ranged from 1 to 7%. The highest percentage of bleeding incidences were seen with bevacizumab, while the lowest percentage of bleeding incidences were seen with axitinib. All of the included trials were of high quality per Jadad scoring. Copyright © 2017 Elsevier B.V. All rights reserved.

The safety and persistence of non-vitamin-K-antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic.

PubMed

Al-Khalili, Faris; Lindström, Catrine; Benson, Lina

2016-01-01

To examine the long-term persistence and safety of the non-vitamin-K-antagonist oral anticoagulants (NOACs) dabigatran (D), rivaroxaban (R) and apixaban (A) in patients with non-valvular atrial fibrillation (AF) treated in the framework of a well structured, nurse-based AF unit for initiation and follow-up of NOAC. Retrospective clinical data were collected for 766 consequent patients from a single cardiology outpatient clinic incorporating the AF unit. The follow-up time, median (q1-q3), was 367 days (183-493) for D patients (n = 233), 432 days (255-546) for R patients (n = 282) and 348 days (267-419) for A patients (n = 251). No significant differences were found between the three groups with regard to age, sex, renal function, or CHA2DS2-VASc score. For all bleeding events the incidence rates per 100 patient-years of follow-up (95% confidence interval [CI], p-value) were reported more often for treatment with R (17.2, 12.7-22.8) than for D (7.0, 4.0-11.3, p = 0.001) and A (8.7, 5.2-13.6, p = 0.013). The differences remained significant after adjustment for clinically relevant variables. Discontinuation rates (n = 167) were lower for A (11.5, 7.5-16.8) than for D (30, 23.4-37.9, p < 0.001) and R (23.9, 18.6-30.1, p = 0.001), and were mainly attributed to drug-specific side effects and bleedings. The majority of discontinued patients (n = 142, 85%) proceeded with other types of oral anticoagulants. The main limitation of the study is the small patient population with a short follow-up time. In a retrospective study at a single AF clinic, NOACs showed significantly different bleeding rates and varied discontinuation rates when compared to each other, related mainly to agent-specific side effects and bleedings. The majority of patients that discontinued proceeded with other types of oral anticoagulant.

Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients.

PubMed

Tapson, Victor F; Hazelton, Joshua P; Myers, John; Robertson, Claudia; Gilani, Ramyar; Dunn, Julie A; Bukur, Marko; Croce, Martin A; Peick, Ann; West, Sonlee; Lottenberg, Lawrence; Doucet, Jay; Miller, Preston R; Crookes, Bruce; Gandhi, Rajesh R; Croft, Chasen A; Manasia, Anthony; Hoey, Brian A; Lieberman, Howard; Guillamondegui, Oscar D; Novack, Victor; Piazza, Gregory; Goldhaber, Samuel Z

2017-09-01

To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval. The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%-100%, P < .01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Comparison of Warfarin use in terms of efficacy and safety in two different polyclinics

PubMed Central

Kılıç, Salih; Kemal, Hatice Soner; Yüce, Elif İlkay; Şimşek, Evrim; Yağmur, Burcu; Akgül, Nuray Memişoğlu; Çınar, Cahide Soydaş; Zoghi, Mehdi; Gürgün, Cemil

2017-01-01

Objective: This study compared the efficacy and safety of warfarin in specialized international normalized ratio (INR) outpatient clinic (INR-C) and in general cardiology outpatient clinic (General-C). Methods: Herein, 381 consecutive patients with a regular follow-up at INR-C (n=233) or General-C (n=148) for at least 1 year were retrospectively included. While INR-C patients were followed by a single experienced trained nurse, General-C patients were followed by a different cardiologist who worked in a rotational principle every month. During controls, demographic characteristics, INR levels, bleeding events, ischemic stroke, and transient ischemic attacks in the last 1 year were recorded. Primary endpoint was defined as the evaluation of the combined major bleeding and ischemic event, and secondary endpoint was defined as the evaluation of them separately. Results: The mean age of the patients was 62±12.86 and 43.8% were male. Mean time in therapeutic range (TTR) level was statistically higher in INR-C than that in General-C (68.8%±15.88 and 51.6%±23.04, respectively; p<0.001). Primary outcomes were significantly higher in General-C than that in INR-C [13.5% (20) and 6.4% (15); respectively, p=0.020]. Overall, major bleeding was observed in 25 patients (6.5%) and (2.6%) ischemic event was observed in 10 patients. In General-C patients, both major bleeding (8.8% vs. 5.2%; p=0.163) and the ischemic event (4.7% vs. 1.3%; p=0.051) were more, and no statistically significant differences were detected between the two clinics. Conclusion: The findings of our study demonstrate that patients followed in INR-C had higher TTR levels and lower bleeding and ischemic events rates that those followed in General-C. PMID:29145216

Abnormal vaginal bleeding in women with venous thromboembolism treated with apixaban or warfarin.

PubMed

Brekelmans, Marjolein P A; Scheres, Luuk J J; Bleker, Suzanne M; Hutten, Barbara A; Timmermans, Anne; Büller, Harry R; Middeldorp, Saskia

2017-04-03

Abnormal vaginal bleeding can complicate direct oral anticoagulant (DOAC) treatment. We aimed to investigate the characteristics of abnormal vaginal bleeding in patients with venous thromboembolism (VTE) receiving apixaban or enoxaparin/warfarin. Data were derived from the AMPLIFY trial. We compared the incidence of abnormal vaginal bleeding between patients in both treatment arms and collected information on clinical presentation, diagnostic procedures, management and outcomes. In the AMPLIFY trial, 1122 women were treated with apixaban and 1106 received enoxaparin/warfarin. A clinically relevant non-major (CRNM) vaginal bleeding occurred in 28 (2.5 %) apixaban and 24 (2.1 %) enoxaparin/warfarin recipients (odds ratio [OR] 1.2, 95 % confidence interval [CI] 0.7-2.0). Of all CRNM bleeds, 28 of 62 (45 %) and 24 of 120 (20 %) were of vaginal origin in the apixaban and enoxaparin/warfarin group, respectively (OR 3.4; 95 % CI 1.8-6.7). Premenopausal vaginal bleeds on apixaban were characterised by more prolonged bleeding (OR 2.3; 95 %CI 0.5-11). In both pre- and postmenopausal vaginal bleeds, diagnostic tests were performed in six (21 %) and in seven (29 %) apixaban and enoxaparin/warfarin treated patients, respectively. Medical treatment was deemed not necessary in 16 (57 %) apixaban and 16 (67 %) enoxaparin/warfarin recipients. The severity of clinical presentation and course of the bleeds was mild in 75 % of the cases in both groups. In conclusion, although the absolute number of vaginal bleeding events is comparable between apixaban and enoxaparin/warfarin recipients, the relative occurrence of vaginal bleeds is higher in apixaban-treated women. The characteristics and severity of bleeding episodes were comparable in both treatment arms.

The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial.

PubMed

Roberts, Ian; Shakur, Haleema; Afolabi, Adefemi; Brohi, Karim; Coats, Tim; Dewan, Yashbir; Gando, Satoshi; Guyatt, Gordon; Hunt, B J; Morales, Carlos; Perel, Pablo; Prieto-Merino, David; Woolley, Tom

2011-03-26

The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. The CRASH-2 trial was undertaken in 274 hospitals in 40 countries. 20,211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health DOH-27-0607-1919. 10,096 patients were allocated to tranexamic acid and 10,115 to placebo, of whom 10,060 and 10,067, respectively, were analysed. 1063 deaths (35%) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0.0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5.3%] events in tranexamic acid group vs 286/3704 [7.7%] in placebo group; relative risk [RR] 0.68, 95% CI 0.57-0.82; p<0.0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4.8%] vs 184/2996 [6.1%]; RR 0.79, 0.64-0.97; p=0.03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4.4%] vs 103/3362 [3.1%]; RR 1.44, 1.12-1.84; p=0.004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Clinical evaluation of influence of aspirin on post-operative bleeding after tooth extraction in the elderly].

PubMed

Wang, Wen-ying; Cui, Nian-hui; Wang, En-bo; Zhang, Wei

2013-05-01

To investigate the feasibility of continuation of aspirin before tooth extraction in the elderly. The patients enrolled in this study were the elderly requiring a single non-impacted tooth extraction. 300 elderly outpatients used lidocaine local infiltration anesthesia, 200 patients without using aspirin before tooth extraction served as control group I, 100 patients with prolong use of aspirin before tooth extraction as observation group I. 300 elderly outpatients used compound articaine local infiltration anesthesia, 200 patients without using aspirin before tooth extraction served as control group II, 100 patients with prolong use of aspirin before tooth extraction as observation group II.Bleedings at 5, 10, 30 min, 24 h after tooth extraction were observed and the relationship between postoperative bleeding and intake of aspirin was analyzed. There was no significant difference at 5, 10, 30 min, 24 h in postoperative bleeding after extraction between control group I and observation group. The incidence of bleeding of observation group II after tooth extraction at 5 min was higher than that of control group II and there was no significant difference at 10, 30 min, 24 h between the two groups. Continuation of aspirin have no influence on postoperative bleeding. Therefore we suggest that there was no indication to discontinue aspirin for the elderly before a single non-impacted tooth extraction.

Early lactate clearance for predicting active bleeding in critically ill patients with acute upper gastrointestinal bleeding: a retrospective study.

PubMed

Wada, Tomoki; Hagiwara, Akiyoshi; Uemura, Tatsuki; Yahagi, Naoki; Kimura, Akio

2016-08-01

Not all patients with upper gastrointestinal bleeding (UGIB) require emergency endoscopy. Lactate clearance has been suggested as a parameter for predicting patient outcomes in various critical care settings. This study investigates whether lactate clearance can predict active bleeding in critically ill patients with UGIB. This single-center, retrospective, observational study included critically ill patients with UGIB who met all of the following criteria: admission to the emergency department (ED) from April 2011 to August 2014; had blood samples for lactate evaluation at least twice during the ED stay; and had emergency endoscopy within 6 h of ED presentation. The main outcome was active bleeding detected with emergency endoscopy. Classification and regression tree (CART) analyses were performed using variables associated with active bleeding to derive a prediction rule for active bleeding in critically ill UGIB patients. A total of 154 patients with UGIB were analyzed, and 31.2 % (48/154) had active bleeding. In the univariate analysis, lactate clearance was significantly lower in patients with active bleeding than in those without active bleeding (13 vs. 29 %, P < 0.001). Using the CART analysis, a prediction rule for active bleeding is derived, and includes three variables: lactate clearance; platelet count; and systolic blood pressure at ED presentation. The rule has 97.9 % (95 % CI 90.2-99.6 %) sensitivity with 32.1 % (28.6-32.9 %) specificity. Lactate clearance may be associated with active bleeding in critically ill patients with UGIB, and may be clinically useful as a component of a prediction rule for active bleeding.

Profiling lifetime episodes of upper gastrointestinal bleeding among patients from rural Sub-Saharan Africa where schistosoma mansoni is endemic.

PubMed

Opio, Christopher Kenneth; Kazibwe, Francis; Ocama, Ponsiano; Rejani, Lalitha; Belousova, Elena Nikolaevna; Ajal, Paul

2016-01-01

Severe chronic hepatic schistosomiasis is a common cause of episodes upper gastrointestinal bleeding (UGIB) in sub-Saharan Africa (SSA). However, there is paucity of data on clinical epidemiology of episodes of UGIB from rural Africa despite on going public health interventions to control and eliminate schistosomiasis. Through a cross sectional study we profiled lifetime episodes of upper gastrointestinal bleeding and associated factors at a rural primary health facility in sub-Saharan Africa were schistosomiasis is endemic. The main outcome was number of lifetime episodes of UGIB analyzed as count data. From 107 enrolled participants, 323 lifetime episodes of UGIB were reported. Fifty-seven percent experienced ≥ 2 lifetime episodes of UGIB. Ninety-four percent had severe chronic hepatic schistosomiasis and 80% esophageal varices. Alcohol use and viral hepatitis was infrequent. Eighty-eight percent were previously treated with praziquantel and 70% had a history of blood transfusion. No patient had ever had an endoscopy or treatment for prevention of recurrent variceal bleeding. Multivariable analysis identified a cluster of eight clinical factor variables (age ≥ 40, female sex, history of blood transfusion, abdominal collaterals, esophageal varices, pattern x periportal fibrosis, anemia, and thrombocytopenia) significantly associated (P-value < 0.05) with increased probability of experiencing two or more lifetime episodes of UGIB in our study. Upper gastrointestinal bleeding is a common health problem in this part of rural SSA where schistosomiasis is endemic. The clinical profile described is unique and is important for improved case management, and for future research.

The comparison of bleeding and pain after tonsillectomy in bipolar electrocautery vs cold dissection.

PubMed

Dadgarnia, Mohammad Hossein; Aghaei, Mohammad Ali; Atighechi, Saeid; Behniafard, Nasim; Vahidi, Mohammad Reza; Meybodian, Mojtaba; Zand, Vahid; Vajihinejad, Maryam; Ansari, Abdollah

2016-10-01

Although tonsillectomy is one of the most common surgeries performed in pediatric, it has potential major complications such as pain and bleeding. This study aimed to compare the bleeding and pain after tonsillectomy in bipolar electrocautery tonsillectomy versus cold dissection. This double blind clinical trial was conducted on 70 pediatric patients who were candidate of tonsillectomy. Patients were divided into two groups of including bipolar cautery (BC) and cold dissection (CD). operation time, intraoperative blood loss, and postoperative bleeding and pain were evaluated in the current study. In both of the CD and BC groups, no significant difference was found in terms of sex and age. The average amount of the intraoperative blood loss in BC group was 14.086 ± 5.013 ml and in CD group was 26.14 ± 4.46 ml (p. v = 0.0001). The mean time of operation in BC group was 19 ± 2.89 min and in CD group was 29.31 ± 5.29 min (p. v = 0.0001). patients were evaluated in terms of pain on the first, third, fifth, and seventh days after the operation. No statistically significant difference was found between two groups. Moreover, Compared pain scores in all times across two groups, no significant difference was found. In terms of postoperative bleeding, none of the patients in both groups had bleeding during follow-up. Our study showed that bipolar electrocautery tonsillectomy can significantly reduce the operation time and intraoperative blood loss; however, postoperative pain and blood loss were similar in both techniques. We recommend bipolar electrocautery as the most suitable alternative method for tonsillectomy, especially in children. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Association between concurrent genital bleeding and cervical cancer: a cross-sectional study.

PubMed

Xavier-Júnior, José C C; Vale, Diama B; Zeferino, Luiz C; Dufloth, Rozany M

2015-09-01

Genital bleeding may be a common symptom among women with cervical cancer. Cross-sectional study evaluating whether the prevalence of cervical smear results is different in women with and without clinical information about concurrent genital bleeding. The sample consisted of 2 324 836 smears; of these, 0.4% had clinical information on genital bleeding. When stratified by age group, women with genital bleeding had a higher chance of a cytological result of a high-grade squamous intraepithelial lesion [30-49 years odds ratio (OR) 2.38; 95% confidence interval (CI) 1.60-3.53 and ≥50 years OR 6.30; 95%CI 3.72-10.67), of squamous cell carcinoma (SCC) (30-49 years OR 24.70; 95%CI 11.96-51.03 and ≥50 years OR 48.91; 95%CI 31.28-76.47) and of atypical glandular cells (30-49 years OR 5.72; 95%CI 3.30-9.93 and ≥50 years OR 11.56; 95%CI 5.96-22.45); there was also a higher chance of adenocarcinoma for women ≥50 years (OR 53.13; 95%CI 28.08-100.51). The sensitivity of genital bleeding for women aged 18-29 years was 0.4% for high-grade squamous intraepithelial lesion (HSIL); for women 30-49 years old the rate was 0.9% for HSIL, 8.6% for SCC and 2.1% for atypical glandular cells of undetermined significance (AGUS), while for women aged from 50 years or more the rates were 2.0% for HSIL, 13.7% for SCC, 3.6% for AGUS and 14.7% for adenocarcinoma. Women ≥30 years old with genital bleeding should be referred for colposcopy to rule out the possibility of cervical cancer. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Safety Outcomes of Apixaban Compared With Warfarin in Patients With End-Stage Renal Disease.

PubMed

Sarratt, Stefanie C; Nesbit, Ross; Moye, Robert

2017-06-01

Current guidelines make no specific recommendations on the selection of direct oral anticoagulants for the prevention and treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) receiving hemodialysis. Based on these guidelines, warfarin remains the anticoagulant of choice in these patients. To compare bleeding rates in patients receiving apixaban or warfarin with ESRD undergoing chronic hemodialysis. This was a single-center, retrospective, institutional review board-approved cohort analysis. Patients with ESRD undergoing chronic hemodialysis and receiving anticoagulation therapy with either apixaban or warfarin were included in this study. All data were collected from paper charts and electronic medical records and included documentation of bleeding events and related interventions. The primary outcome of this study was clinically relevant major bleeding events. Secondary outcomes included clinically relevant nonmajor bleeding events and minor bleeding events. A total of 160 patients were included in this study (warfarin group, n = 120; apixaban group, n = 40). There were 7 major bleeding events in the warfarin group compared with zero in the apixaban group ( P = 0.34). There were similar rates of clinically relevant nonmajor bleeding events (12.5% vs 5.8%, P = 0.17) and minor bleeding (2.5% vs 2.5%, P = 0.74) events in patients receiving apixaban and warfarin. There were no observed differences in bleeding rates in patients receiving apixaban compared with those receiving warfarin. Apixaban may be a cautious consideration in hemodialysis patients until there is further insight into the effect of subsequent, multiple doses on drug accumulation and clinical outcomes.

Risk of Atrial Fibrillation and Bleeding Diathesis Associated With Ibrutinib Treatment: A Systematic Review and Pooled Analysis of Four Randomized Controlled Trials.

PubMed

Yun, Seongseok; Vincelette, Nicole D; Acharya, Utkarsh; Abraham, Ivo

2017-01-01

Clinical trials raised concern that ibrutinib may increase the risk of atrial fibrillation/flutter (Afib/Aflutter) and major bleeding. However, the association has not been statistically validated, and there is no consensus regarding optimal management of anticoagulation among patients receiving ibrutinib who develop Afib/Aflutter. We performed a systematic review and pooled analysis to precisely assess the risk of Afib/Aflutter and bleeding associated with ibrutinib treatment in patients with hematologic malignancies. We searched PubMed, EMBASE, Cochrane Database, and meeting abstracts up to May 15, 2016, for randomized controlled trials comparing ibrutinib to chemotherapy, monoclonal antibody, or a combination. Primary outcomes were serious Afib/Aflutter and major bleeding. Secondary outcomes were all-grade Afib/Aflutter and bleeding. We calculated the Mantel-Haenszel risk ratio (RR) and estimated the effect of the treatments using a fixed-effects model. Ibrutinib treatment was associated with a significantly higher incidence of serious Afib/Aflutter (3.03% vs. 0.80%, RR = 3.80, 95% confidence interval [CI] = 1.56-9.29, P = .003), all-grade Afib/Aflutter (8.18% vs. 0.93%, RR = 8.81, 95% CI = 2.70-28.75, P = .0003), and all-grade bleeding (4.85% vs. 1.55%, RR = 2.93, 95% CI = 1.14-7.52, P = .03) compared to control treatments. The observed between-treatment difference in major bleeding rates was not statistically significant (3.69% vs. 2.13%, RR = 1.72, 95% CI = 0.95-3.11, P = .07). The risk of these adverse events was not different between subgroups on the basis of pathology, treatment setting, dose, and duration of ibrutinib exposure. The risks of Afib/Aflutter and all-grade bleeding were significantly higher in the ibrutinib group. These results indicate the need for vigilant monitoring while the patient is receiving ibrutinib therapy, and careful assessment of the risks and benefits of anticoagulation is required. Copyright © 2016 Elsevier Inc. All rights reserved.

Delayed hematologic toxicity following rattlesnake envenomation unresponsive to crotalidae polyvalent antivenom.

PubMed

Bailey, Abby M; Justice, Stephanie; Davis, George A; Weant, Kyle

2017-07-01

North American rattlesnake envenomations are known to produce coagulopathies and thrombocytopenia. However, the occurrence of delayed hematologic toxicity (less than seven days after envenomation) is poorly characterized in the medical literature. While the recurrence of hematologic derangements has been documented following envenomation, it is usually in the absence of clinically significant bleeding. Although commonly recommended to treat delayed coagulopathies, the effectiveness of crotalidae polyvalent immune Fab ovine (CroFab®) in managing this condition remains in question and warrants further investigation and exploration. We describe the case of a 19-year-old male who presented following rattlesnake envenomation at a church service who was treated with antivenin for 48 h and discharged home only to return four days later with profound thrombocytopenia, coagulopathy, and clinically significant bleeding. Copyright © 2017 Elsevier Inc. All rights reserved.

The spontaneous resolution of heavy menstrual bleeding in the perimenopausal years

PubMed Central

Shapley, M; Blagojevic, M; Jordan, KP; Croft, PR

2012-01-01

Objective To obtain estimates of the rate of spontaneous resolution of heavy menstrual bleeding and to explore any association with specific menstrual symptoms. Design Two-year prospective cohort study. Setting Seven general practices, with 67 100 registered patients. Population All women aged 40–54 years on the practices age–sex registers. Methods Baseline postal questionnaire, with follow-up questionnaires sent to naturally menstruating respondents at 6, 12, 18 and 24 months. Main outcome measures Rate of spontaneous resolution of heavy menstrual bleeding in naturally menstruating women. Results A total of 7121 baseline questionnaires were sent out, with an initial response rate of 63%. We recruited 2051 naturally menstruating women for the prospective cohort study. The spontaneous rate of resolution of heavy menstrual bleeding varied from 8.1% (95% CI 5.3–12%) in women aged 45–49 years, who had resolution without recurrence for 24 months, to 35% (95% CI 30–41%) in women aged 50–54 years, who had resolution without recurrence for 6 months. Rates were lower in those who reported interference with life from heavy menstrual bleeding. There was a strong association between the spontaneous resolution of heavy menstrual bleeding and skipped periods in women aged over 45 years. The association with ‘cycle too variable to say’ was significant, but weaker. Conclusion There is a high prevalence, incidence and significant spontaneous rate of resolution of heavy menstrual bleeding in naturally menstruating women during the perimenopausal years. The rates have potential use for individual women, clinical decisions, devising and implementing interventions and planning the care of populations. Please cite this paper as: Shapley M, Blagojevic M, Jordan K, Croft P. The spontaneous resolution of heavy menstrual bleeding in the perimenopausal years. BJOG 2012;119:545–553. PMID:22313942

[Comparison between Endoscopic Therapy and Medical Therapy in Peptic Ulcer Patients with Adherent Clot: A Multicenter Prospective Observational Cohort Study].

PubMed

Kim, Si Hye; Jung, Jin Tae; Kwon, Joong Goo; Kim, Eun Young; Lee, Dong Wook; Jeon, Seong Woo; Park, Kyung Sik; Lee, Si Hyung; Park, Jeong Bae; Ha, Chang Yoon; Park, Youn Sun

2015-08-01

The optimal management of bleeding peptic ulcer with adherent clot remains controversial. The purpose of this study was to compare clinical outcome between endoscopic therapy and medical therapy. We also evaluated the risk factors of rebleeding in Forrest type IIB peptic ulcer. Upper gastrointestinal (UGI) bleeding registry data from 8 hospitals in Korea between February 2011 and December 2013 were reviewed and categorized according to the Forrest classification. Patients with acute UGI bleeding from peptic ulcer with adherent clots were enrolled. Among a total of 1,101 patients diagnosed with peptic ulcer bleeding, 126 bleedings (11.4%) were classified as Forrest type IIB. Of the 126 patients with adherent clots, 84 (66.7%) received endoscopic therapy and 42 (33.3%) were managed with medical therapy alone. The baseline characteristics of patients in two groups were similar except for higher Glasgow Blatchford Score and pre-endoscopic Rockall score in medical therapy group. Bleeding related mortality (1.2% vs.10%; p=0.018) and all cause mortality (3.7% vs. 20.0%; p=0.005) were significantly lower in the endoscopic therapy group. However, there was no difference between endoscopic therapy and medical therapy regarding rebleeding (7.1% vs. 9.5%; p=0.641). In multivariate analysis, independent risk factors of rebleeding were previous medication with aspirin and/or NSAID (OR, 13.1; p=0.025). In patients with Forrest type IIB peptic ulcer bleeding, endoscopic therapy was associated with a significant reduction in bleeding related mortality and all cause mortality compared with medical therapy alone. Important risk factor of rebleeding was use of aspirin and/or NSAID.

Clinical utility of new bleeding criteria: a prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention.

PubMed

Choi, Jae-Hyuk; Seo, Jeong-Min; Lee, Dong Hyun; Park, Kyungil; Kim, Young-Dae

2015-04-01

The aim of this study was to evaluate the clinical utility of the new bleeding criteria, proposed by the Bleeding Academic Research Consortium (BARC), compared with the old criteria for determining the action of physicians in contact with bleeding events, after percutaneous coronary intervention (PCI). The BARC criteria were independently associated with an increased risk of 1-year mortality after PCI, and provided a predictive value, in regard to 1-year mortality. The standardized bleeding definitions will be expected to help the physician to correctly analyze the bleeding events, to select an optimal treatment, and to objectively compare the results of multiple trials and registries. All the patients undergoing PCI from June to September 2012 were prospectively enrolled. Patients who experienced a bleeding event were further classified, based on three different bleeding severity criteria: BARC, Thrombolysis In Myocardial Infarction (TIMI), and Global Use of Strategies To Open coronary arteries (GUSTO). The primary outcome was the occurrence of bleeding events requiring interruption of antiplatelet therapy (IAT) by physicians. A total of 376 consecutive patients were included in this study. Total bleeding events occurred in 46 patients (12.2%). BARC type ≥2 bleeding occurred in 30 patients (8.0%); however, TIMI major or minor bleeding, and GUSTO moderate or severe bleeding occurred in 6 (1.6%) and 11 patients (2.9%), respectively. Of the 46 patients, 28 (60.9% of patients) required IAT. On receiver-operating characteristic curve analysis, bleeding defined BARC type ≥2 effectively predicted IAT, with a sensitivity of 89.3%, and a specificity of 98.5% (p<0.001), compared with TIMI (sensitivity, 21.4%; specificity, 100%; p<0.001), and GUSTO (sensitivity, 39.3%; specificity, 100%; p<0.001). Compared with TIMI and GUSTO, the BARC definition may be a more useful tool for the detection of bleeding with clinical relevance, for patients undergoing PCI. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Questioning our Questions: Do frequently asked questions adequately cover the aspects of women's lives most affected by abnormal uterine bleeding? Opinions of women with abnormal uterine bleeding participating in focus group discussions

PubMed Central

Matteson, Kristen A.; Clark, Melissa A.

2010-01-01

Objectives: (1) To explore the effects on women's lives by heavy or irregular menstrual bleeding; (2) To examine whether aspects of women's lives most affected by heavy or irregular menstrual bleeding were adequately addressed by questions that are frequently used in clinical encounters and available questionnaires. Methods: We conducted four focus group sessions with a total of 25 English-speaking women who had reported abnormal uterine bleeding. Discussions included open-ended questions that pertained to bleeding, aspects of life affected by bleeding, and questions frequently used in clinical settings about bleeding and quality of life. Results: We identified five themes that reflected how women's lives were affected by heavy or irregular menstrual bleeding: irritation/inconvenience, bleeding-associated pain, self-consciousness about odor, social embarrassment, and ritual like behavior. Although women responded that the frequently used questions about bleeding and quality of life were important, they felt that the questions failed to go into enough depth to adequately characterize their experiences. Conclusions: Based on the themes identified in our focus group sessions, clinicians and researchers may need to change the questions used to capture “patient experience” with abnormal uterine bleeding more accurately. PMID:20437305

Impact of renal function on ischemic stroke and major bleeding rates in nonvalvular atrial fibrillation patients treated with warfarin or rivaroxaban: a retrospective cohort study using real-world evidence.

PubMed

Weir, Matthew R; Berger, Jeffrey S; Ashton, Veronica; Laliberté, François; Brown, Kip; Lefebvre, Patrick; Schein, Jeffrey

2017-10-01

Renal dysfunction is associated with increased risk of cardiovascular disease and is an independent predictor of stroke and systemic embolism. Nonvalvular atrial fibrillation (NVAF) patients with renal dysfunction may face a particularly high risk of thromboembolism and bleeding. The current retrospective cohort study was designed to assess the impact of renal function on ischemic stroke and major bleeding rates in NVAF patients in the real-world setting (outside a clinical trial). Medical claims and Electronic Health Records were retrieved retrospectively from Optum's Integrated Claims-Clinical de-identified dataset from May 2011 to August 2014. Patients with NVAF treated with warfarin (2468) or rivaroxaban (1290) were selected. Each treatment cohort was stratified by baseline estimated creatinine clearance (eCrCl) levels. Confounding adjustments were made using inverse probability of treatment weights (IPTWs). Incidence rates and hazard ratios of ischemic stroke and major bleeding events were calculated for both cohorts. Overall, patients treated with rivaroxaban had an ischemic stroke incidence rate of 1.9 per 100 person-years (PY) while patients treated with warfarin had a rate of 4.2 per 100 PY (HR = 0.41 [0.21-0.80], p = .009). Rivaroxaban patients with an eCrCl below 50 mL/min (N = 229) had an ischemic stroke rate of 0.8 per 100 PY, while the rate for the warfarin cohort (N = 647) was 6.0 per 100 PY (HR = 0.09 [0.01-0.72], p = .02). For the other renal function levels (i.e. eCrCl 50-80 and ≥80 mL/min) HRs indicated no statistically significant differences in ischemic stroke risks. Bleeding events did not differ significantly between cohorts stratified by renal function. Ischemic stroke rates were significantly lower in the overall NVAF population for rivaroxaban vs. warfarin users, including patients with eCrCl below 50 mL/min. For all renal function groups, major bleeding risks were not statistically different between treatment groups.

Complete prevention of blood loss with self-sealing haemostatic needles

NASA Astrophysics Data System (ADS)

Shin, Mikyung; Park, Sung-Gurl; Oh, Byung-Chang; Kim, Keumyeon; Jo, Seongyeon; Lee, Moon Sue; Oh, Seok Song; Hong, Seon-Hui; Shin, Eui-Cheol; Kim, Ki-Suk; Kang, Sun-Woong; Lee, Haeshin

2017-01-01

Bleeding is largely unavoidable following syringe needle puncture of biological tissues and, while inconvenient, this typically causes little or no harm in healthy individuals. However, there are certain circumstances where syringe injections can have more significant side effects, such as uncontrolled bleeding in those with haemophilia, coagulopathy, or the transmission of infectious diseases through contaminated blood. Herein, we present a haemostatic hypodermic needle able to prevent bleeding following tissue puncture. The surface of the needle is coated with partially crosslinked catechol-functionalized chitosan that undergoes a solid-to-gel phase transition in situ to seal punctured tissues. Testing the capabilities of these haemostatic needles, we report complete prevention of blood loss following intravenous and intramuscular injections in animal models, and 100% survival in haemophiliac mice following syringe puncture of the jugular vein. Such self-sealing haemostatic needles and adhesive coatings may therefore help to prevent complications associated with bleeding in more clinical settings.

The Relationship Between Serum Neuron-Specific Enolase Levels and Severity of Bleeding and Functional Outcomes in Patients With Nontraumatic Subarachnoid Hemorrhage.

PubMed

Tawk, Rabih G; Grewal, Sanjeet S; Heckman, Michael G; Rawal, Bhupendra; Miller, David A; Edmonston, Drucilla; Ferguson, Jennifer L; Navarro, Ramon; Ng, Lauren; Brown, Benjamin L; Meschia, James F; Freeman, William D

2016-04-01

The value of neuron-specific enolase (NSE) in predicting clinical outcomes has been investigated in a variety of neurological disorders. To investigate the associations of serum NSE with severity of bleeding and functional outcomes in patients with subarachnoid hemorrhage (SAH). We retrospectively reviewed the records of patients with SAH from June 2008 to June 2012. The severity of SAH bleeding at admission was measured radiographically with the Fisher scale and clinically with the Glasgow Coma Scale, Hunt and Hess grade, and World Federation of Neurologic Surgeons scale. Outcomes were assessed with the modified Rankin Scale at discharge. We identified 309 patients with nontraumatic SAH, and 71 had NSE testing. Median age was 54 years (range, 23-87 years), and 44% were male. In multivariable analysis, increased NSE was associated with a poorer Hunt and Hess grade (P = .003), World Federation of Neurologic Surgeons scale score (P < .001), and Glasgow Coma Scale score (P = .003) and worse outcomes (modified Rankin Scale at discharge; P = .001). There was no significant association between NSE level and Fisher grade (P = .81) in multivariable analysis. We found a significant association between higher NSE levels and poorer clinical presentations and worse outcomes. Although it is still early for any relevant clinical conclusions, our results suggest that NSE holds promise as a tool for screening patients at increased risk of poor outcomes after SAH.

Effects of platelet concentrate storage time reduction in patients after blood stem cell transplantation.

PubMed

Heuft, H-G; Goudeva, L; Krauter, J; Peest, D; Buchholz, S; Tiede, A

2013-07-01

To evaluate the clinical effect of platelet concentrate (PC) transfusions after PC storage time reduction to 4 days. This was a single-centre cohort study comparing two 3-month periods of time, before and after the reduction of PC storage time from 5 to 4 days. Seventy-seven consecutive patients with PC transfusions were enrolled after blood stem cell transplantation. Corrected platelet count increment (CCI) on the morning after transfusion, time to next platelet transfusion, need for red blood cell (RBC) transfusion and clinical bleeding symptoms were compared. Platelet concentrate storage time was reduced between period 1 (storage for up to 5 days, median storage time 78 h, range 11-136 h) and period 2 (storage for up to 4 days, median storage time 53 h, range 11-112 h). Patients were comparable for age, weight, body surface area, underlying disorder, type of transplantation and transfused platelet dose. The CCI increased from a median of 4 (range 0-20) to 8 (0-68) × 10(9) /l per 10(11) platelets/m(2) (P < 0·0001). Time to next PC transfusion increased from 1·1 to 2·0 days (P < 0·0001). Any bleeding symptom was noted in 20 of 36 patients (56%) vs. 9/41 patients (22%, P < 0·01). Nose bleeds, haematuria and bleeding at more than one site were significantly reduced. Frequency of RBC transfusion within 5 days after PC transfusion was reduced from 74 to 58% (P < 0·0001). Platelet concentrate storage time shortening was associated with highly significant CCI increase, reduced RC needs and lower patient numbers with bleeding events. © 2013 International Society of Blood Transfusion.

Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy

PubMed Central

Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

2017-01-01

AIM To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. METHODS This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn’t routinely performed. RESULTS Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CONCLUSION CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required. PMID:28127206

Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy.

PubMed

Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

2017-01-14

To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn't routinely performed. Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required.

Pediatric Pulmonary Hemorrhage vs. Extrapulmonary Bleeding in the Differential Diagnosis of Hemoptysis.

PubMed

Vaiman, Michael; Klin, Baruch; Rosenfeld, Noa; Abu-Kishk, Ibrahim

2017-01-01

Hemoptysis is an important symptom which causes a major concern, and warrants immediate diagnostic attention. The authors compared a group of patients with pediatric pulmonary hemorrhage with pediatric patients diagnosed with extrapulmonary bleeding focusing on differences in etiology, outcome and differential diagnosis of hemoptysis. We performed the retrospective analysis of medical charts of 134 pediatric patients admitted to the Emergency Department because of pulmonary and extrapulmonary hemorrhage and were diagnosed with suspected hemoptysis or developed hemoptysis (ICD10-CM code R04.2). The cases with pulmonary hemorrhage (Group 1) were compared with cases of extrapulmonary bleeding (Group 2) using the Fisher Exact test or Pearson's χ 2 test for categorical variables. The t-test was used to assess differences between continuous variables of the patients in the two groups. Bloody cough was the presenting symptom in 73.9% of cases. 30 patients had pulmonary hemorrhage (Group 1), while 104 patients had extrapulmonary bleeding (Group 2). The underlying causes of bleeding in Group 2 included epistaxis, inflammatory diseases of nasopharynx and larynx, foreign bodies, gingivitis, and hypertrophy of adenoids. Mortality rate was 10% in Group 1, whereas Group 2 did not have any mortality outcomes during the observation period. Etiologycal factors were significantly different between hemoptysis and extrapulmonary bleeding in children. Our research suggested that pulmonary and extrapulmonary bleeding are two conditions that differ significantly and cannot be unified under one diagnostic code. It is important to differentiate between focal and diffuse cases, and between pulmonary and extrapulmonary hemorrhage due to the diversity of clinical courses and outcomes.

Serendipitous Discovery of Factor VII Deficiency and the Ensuing Dilemma.

PubMed

Umakanthan, Jayadev M; Dhakal, Prajwal; Gundabolu, Krishna; Koepsell, Scott A; Baljevic, Muhamed

2018-03-01

Congenital factor VII deficiency is a challenging disorder to manage, as it is associated with varied genotypes that do not clinically correlate with a bleeding phenotype. Individuals with severe factor VII deficiency (FVII: c <1%) might be asymptomatic, while patients with moderate deficiency (FVII: c level >5%) may experience severe hemorrhages. In modern medicine, due to extensive routine pre-operative laboratory testing, clinically asymptomatic patients without any bleeding history might be incidentally discovered, raising clinical dilemmas. Careful consideration of bleeding versus thrombosis risk has to be made in such cases, especially in the elderly. Clinical history of no prior bleeding complications may be a reassuring factor. Minimal required replacement dosing of recombinant activated factor VII can be given peri-operatively in such situations, with close monitoring.

Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study

PubMed Central

Naber, Christoph K.; Urban, Philip; Ong, Paul J.; Valdes-Chavarri, Mariano; Abizaid, Alexandre A.; Pocock, Stuart J.; Fabbiocchi, Franco; Dubois, Christophe; Copt, Samuel; Greene, Samantha; Morice, Marie-Claude

2017-01-01

Aims Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. Methods and results Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005). Conclusion We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication. PMID:27190095

Anti-factor IXa/X bispecific antibody ACE910 prevents joint bleeds in a long-term primate model of acquired hemophilia A

PubMed Central

Yoshihashi, Kazutaka; Takeda, Minako; Kitazawa, Takehisa; Soeda, Tetsuhiro; Igawa, Tomoyuki; Sampei, Zenjiro; Kuramochi, Taichi; Sakamoto, Akihisa; Haraya, Kenta; Adachi, Kenji; Kawabe, Yoshiki; Nogami, Keiji; Shima, Midori; Hattori, Kunihiro

2014-01-01

ACE910 is a humanized anti-factor IXa/X bispecific antibody mimicking the function of factor VIII (FVIII). We previously demonstrated in nonhuman primates that a single IV dose of ACE910 exerted hemostatic activity against hemophilic bleeds artificially induced in muscles and subcutis, and that a subcutaneous (SC) dose of ACE910 showed a 3-week half-life and nearly 100% bioavailability, offering support for effective prophylaxis for hemophilia A by user-friendly SC dosing. However, there was no direct evidence that such SC dosing of ACE910 would prevent spontaneous bleeds occurring in daily life. In this study, we newly established a long-term primate model of acquired hemophilia A by multiple IV injections of an anti-primate FVIII neutralizing antibody engineered in mouse-monkey chimeric form to reduce its antigenicity. The monkeys in the control group exhibited various spontaneous bleeding symptoms as well as continuous prolongation of activated partial thromboplastin time; notably, all exhibited joint bleeds, which are a hallmark of hemophilia. Weekly SC doses of ACE910 (initial 3.97 mg/kg followed by 1 mg/kg) significantly prevented these bleeding symptoms; notably, no joint bleeding symptoms were observed. ACE910 is expected to prevent spontaneous bleeds and joint damage in hemophilia A patients even with weekly SC dosing, although appropriate clinical investigation is required. PMID:25274508

Prevalence of serious bleeding events and intracranial hemorrhage in patients receiving activated protein C: a systematic review and meta-analysis.

PubMed

Khan, Ajmal; Agarwal, Ritesh; Aggarwal, Ashutosh N; Gupta, Dheeraj

2010-07-01

Activated protein C reduces 28-day mortality in patients with severe sepsis, but its anticoagulant properties entail a risk of bleeding. The aim of this systematic review was to evaluate the prevalence of serious bleeding events in patients receiving activated protein C. We searched the MEDLINE and EMBASE databases for studies that described the prevalence of serious bleeding events and intracranial hemorrhage in patients receiving activated protein C. We calculated the bleeding rates by calculating proportions and 95% CIs for each study, and then pooled the data to derive a pooled proportion and 95% CI. Our search yielded 17 studies, which included 10,679 patients. The occurrence of serious bleeding events in patients receiving activated protein C ranged from 0.5% to 9.6%, and the pooled prevalence was 3.3% (95% CI 2.4-4.4%) by the random effects model. The occurrence of intracranial hemorrhage ranged from 0% to 1.4%, and the pooled prevalence was 0.44% (95% CI 0.31-0.6%). Sensitivity analysis showed a higher prevalence of bleeding in the observational studies than in the randomized controlled trials. There was substantial clinical and statistical heterogeneity, but no evidence of publication bias. Activated protein C is associated with significant risk of bleeding, so strict inclusion and exclusion criteria should be set prior to administering activated protein C.

Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib.

PubMed

Lipsky, Andrew H; Farooqui, Mohammed Z H; Tian, Xin; Martyr, Sabrina; Cullinane, Ann M; Nghiem, Khanh; Sun, Clare; Valdez, Janet; Niemann, Carsten U; Herman, Sarah E M; Saba, Nakhle; Soto, Susan; Marti, Gerald; Uzel, Gulbu; Holland, Steve M; Lozier, Jay N; Wiestner, Adrian

2015-12-01

Ibrutinib is associated with bleeding-related adverse events of grade ≤ 2 in severity, and infrequently with grade ≥ 3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤ 2 bleeding-related adverse events in 55% of 85 patients. No grade ≥ 3 events occurred. Median time to event was 49 days. The cumulative incidence of an event plateaued by 6 months, suggesting that the risk of bleeding decreases with continued therapy. At baseline, von Willebrand factor and factor VIII levels were often high and normalized on treatment. Platelet function measured via the platelet function analyzer (PFA-100™) was impaired in 22 patients at baseline and in an additional 19 patients on ibrutinib (often transiently). Collagen and adenosine diphosphate induced platelet aggregation was tested using whole blood aggregometry. Compared to normal controls, response to both agonists was decreased in all patients with chronic lymphocytic leukemia, whether on ibrutinib or not. Compared to untreated chronic lymphocytic leukemia patients, response to collagen showed a mild further decrement on ibrutinib, while response to adenosine diphosphate improved. All parameters associated with a significantly increased risk of bleeding-related events were present at baseline, including prolonged epinephrine closure time (HR 2.74, P=0.012), lower levels of von Willebrand factor activity (HR 2.73, P=0.009) and factor VIII (HR 3.73, P=0.0004). In conclusion, both disease and treatment-related factors influence the risk of bleeding. Patients at greater risk for bleeding of grade ≤ 2 can be identified by clinical laboratory tests and counseled to avoid aspirin, non-steroidal anti-inflammatory drugs and fish oils. ClinicalTrials.gov identifier NCT01500733. Copyright© Ferrata Storti Foundation.

Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib

PubMed Central

Lipsky, Andrew H.; Farooqui, Mohammed Z.H.; Tian, Xin; Martyr, Sabrina; Cullinane, Ann M.; Nghiem, Khanh; Sun, Clare; Valdez, Janet; Niemann, Carsten U.; Herman, Sarah E. M.; Saba, Nakhle; Soto, Susan; Marti, Gerald; Uzel, Gulbu; Holland, Steve M.; Lozier, Jay N.; Wiestner, Adrian

2015-01-01

Ibrutinib is associated with bleeding-related adverse events of grade ≤2 in severity, and infrequently with grade ≥3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤2 bleeding-related adverse events in 55% of 85 patients. No grade ≥3 events occurred. Median time to event was 49 days. The cumulative incidence of an event plateaued by 6 months, suggesting that the risk of bleeding decreases with continued therapy. At baseline, von Willebrand factor and factor VIII levels were often high and normalized on treatment. Platelet function measured via the platelet function analyzer (PFA-100™) was impaired in 22 patients at baseline and in an additional 19 patients on ibrutinib (often transiently). Collagen and adenosine diphosphate induced platelet aggregation was tested using whole blood aggregometry. Compared to normal controls, response to both agonists was decreased in all patients with chronic lymphocytic leukemia, whether on ibrutinib or not. Compared to untreated chronic lymphocytic leukemia patients, response to collagen showed a mild further decrement on ibrutinib, while response to adenosine diphosphate improved. All parameters associated with a significantly increased risk of bleeding-related events were present at baseline, including prolonged epinephrine closure time (HR 2.74, P=0.012), lower levels of von Willebrand factor activity (HR 2.73, P=0.009) and factor VIII (HR 3.73, P=0.0004). In conclusion, both disease and treatment-related factors influence the risk of bleeding. Patients at greater risk for bleeding of grade ≤2 can be identified by clinical laboratory tests and counseled to avoid aspirin, non-steroidal anti-inflammatory drugs and fish oils. ClinicalTrials.gov identifier NCT01500733 PMID:26430171

Subclinical Early Post-Traumatic Seizures Detected by Continuous EEG Monitoring in a Consecutive Pediatric Cohort

PubMed Central

Arndt, Daniel H; Lerner, Jason T; Matsumoto, Joyce H; Madikians, Andranik; Yudovin, Sue; Valino, Heather; McArthur, David L; Wu, Joyce Y; Leung, Michelle; Buxley, Farzad; Szeliga, Conrad; Van Hirtum-Das, Michele; Sankar, Raman; Brooks-Kayal, Amy; Giza, Christopher C

2015-01-01

Summary Purpose Traumatic brain injury (TBI) is an important cause of morbidity and mortality in children and early post-traumatic seizures (EPTS) are a contributing factor to ongoing acute damage. Continuous video EEG monitoring (cEEG) was utilized to assess the burden of clinical and electrographic EPTS. Methods Eighty-seven consecutive, unselected (mild – severe), acute TBI patients requiring pediatric intensive care unit (PICU) admission at 2 academic centers were prospectively monitored with cEEG per established clinical TBI protocols. Clinical and subclinical seizures and status epilepticus (SE, clinical and subclinical) were assessed for their relation to clinical risk factors and short-term outcome measures. Key findings Of all patients, 42.5% (37/87) had seizures. Younger age (p=0.002) and mechanism (abusive head trauma - AHT, p<0.001) were significant risk factors. Subclinical seizures occurred in 16.1% (14/87), 6 of whom had only subclinical seizures. Risk factors for subclinical seizures included: younger age (p<0.001), AHT (p<0.001) and intraaxial bleed (p<0.001). Status Epilepticus (SE) occurred in 18.4% (16/87) with risk factors including: younger age (p<0.001), AHT (p<0.001), and intraaxial bleed (p=0.002). Subclinical SE was detected in 13.8% (12/87) with significant risk factors including: younger age (p<0.001), AHT (p=0.001), and intraaxial bleed (p=0.004). Subclinical seizures were associated with lower discharge KOSCHI score (p=0.002). SE and subclinical SE were associated with increased hospital length of stay (p=0.017 and p=0.041 respectively) and lower hospital discharge KOSCHI (p=0.007 and p=0.040 respectively). Significance cEEG monitoring significantly improves detection of seizures/SE and is the only way to detect subclinical seizures/SE. cEEG may be indicated after pediatric TBI, particularly in younger children, AHT cases, and those with intraaxial blood on CT. PMID:24032982

Effectiveness of enamel matrix derivative on the clinical and microbiological outcomes following surgical regenerative treatment of peri-implantitis. A randomized controlled trial.

PubMed

Isehed, Catrine; Holmlund, Anders; Renvert, Stefan; Svenson, Björn; Johansson, Ingegerd; Lundberg, Pernilla

2016-10-01

This randomized clinical trial aimed at comparing radiological, clinical and microbial effects of surgical treatment of peri-implantitis alone or in combination with enamel matrix derivative (EMD). Twenty-six subjects were treated with open flap debridement and decontamination of the implant surfaces with gauze and saline preceding adjunctive EMD or no EMD. Bone level (BL) change was primary outcome and secondary outcomes were changes in pocket depth (PD), plaque, pus, bleeding and the microbiota of the peri-implant biofilm analyzed by the Human Oral Microbe Identification Microarray over a time period of 12 months. In multivariate modelling, increased marginal BL at implant site was significantly associated with EMD, the number of osseous walls in the peri-implant bone defect and a Gram+/aerobic microbial flora, whereas reduced BL was associated with a Gram-/anaerobic microbial flora and presence of bleeding and pus, with a cross-validated predictive capacity (Q(2) ) of 36.4%. Similar, but statistically non-significant, trends were seen for BL, PD, plaque, pus and bleeding in univariate analysis. Adjunctive EMD to surgical treatment of peri-implantitis was associated with prevalence of Gram+/aerobic bacteria during the follow-up period and increased marginal BL 12 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

EVALUATION OF CLINICAL PERIODONTAL CONDITIONS IN SMOKERS AND NON-SMOKERS

PubMed Central

Luzzi, Lucinara Ignez Tavares; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir; Sant'ana, Adriana Campos Passanezi; Lauris, José Roberto Pereira; Cestari, Tânia Mary

2007-01-01

Given that tobacco smoking habit is a risk factor for periodontal diseases, the aim of this study was to compare clinical periodontal aspects between smokers and non-smokers. The clinical status were assessed in 55 patients, 29 smokers and 26 non-smokers, aged 30 to 50 years, with mean age of 40. The clinical parameters used were: probing depth (PD), plaque index (PI), gingival index (GI), clinical attachment level (CAL), gingival recession (GR) and gingival bleeding index (GBI) for arches (upper and lower) and teeth (anterior and posterior). Tooth loss was also evaluated in both groups. Multiple regression analysis showed: tendency of greater probing depth and clinical attachment level means for smokers; greater amount of plaque in smokers in all regions; greater gingival index means for non-smokers with clinical significance (p<0.05) in all regions. Although, without statistical significance, the analysis showed greater gingival bleeding index means almost always for non-smokers; similar gingival recession means in both groups and tendency of upper tooth loss in smokers and lower tooth loss in non-smokers. The findings of this study showed that clinical periodontal parameters may be different in smokers when compared to non-smokers and that masking of some periodontal signs can be a result of nicotine's vasoconstrictor effect. PMID:19089190

Does the disparity in baseline characteristics of patients undergoing transcatheter aortic valve replacement with 23 mm vs. 26 mm valves impact clinical outcome?

PubMed

Escárcega, Ricardo O; Magalhaes, Marco A; Baker, Nevin C; Lipinski, Michael J; Minha, Sa'ar; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2016-01-01

We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Lingual Haematoma due to Tenecteplase in a Patient with Acute Myocardial Infarction

PubMed Central

Bal, Muhlis; Salturk, Ziya; Ateş, Ahmet Hakan; Yağcı, Serkan; Coşkun Bal, Gökçen

2013-01-01

The use of intravenous thrombolytic agents has revolutionised the treatment of acute myocardial infarction. However, the improvement in mortality rate achieved with these drugs is tempered by the risk of serious bleeding complications, including intracranial haemorrhage. Tenecteplase is a genetically engineered mutant tissue plasminogen activator. Haemorrhagic complications of tissue plasminogen activator (tPA) are well known. Compared to other tPAs, tenecteplase use leads to lower rates of bleeding complications. Here, we report a case of unusual site of spontaneous bleeding, intralingual haematoma during tenecteplase therapy following acute myocardial infarction, which caused significant upper airway obstruction and required tracheotomy to maintain the patient's airway. Clinical dilemmas related to securing the airway or reversing the effects of tissue plasminogen activator are discussed. PMID:23862086

ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding.

PubMed

Gerson, Lauren B; Fidler, Jeff L; Cave, David R; Leighton, Jonathan A

2015-09-01

Bleeding from the small intestine remains a relatively uncommon event, accounting for ~5-10% of all patients presenting with gastrointestinal (GI) bleeding. Given advances in small bowel imaging with video capsule endoscopy (VCE), deep enteroscopy, and radiographic imaging, the cause of bleeding in the small bowel can now be identified in most patients. The term small bowel bleeding is therefore proposed as a replacement for the previous classification of obscure GI bleeding (OGIB). We recommend that the term OGIB should be reserved for patients in whom a source of bleeding cannot be identified anywhere in the GI tract. A source of small bowel bleeding should be considered in patients with GI bleeding after performance of a normal upper and lower endoscopic examination. Second-look examinations using upper endoscopy, push enteroscopy, and/or colonoscopy can be performed if indicated before small bowel evaluation. VCE should be considered a first-line procedure for small bowel investigation. Any method of deep enteroscopy can be used when endoscopic evaluation and therapy are required. VCE should be performed before deep enteroscopy if there is no contraindication. Computed tomographic enterography should be performed in patients with suspected obstruction before VCE or after negative VCE examinations. When there is acute overt hemorrhage in the unstable patient, angiography should be performed emergently. In patients with occult hemorrhage or stable patients with active overt bleeding, multiphasic computed tomography should be performed after VCE or CTE to identify the source of bleeding and to guide further management. If a source of bleeding is identified in the small bowel that is associated with significant ongoing anemia and/or active bleeding, the patient should be managed with endoscopic therapy. Conservative management is recommended for patients without a source found after small bowel investigation, whereas repeat diagnostic investigations are recommended for patients with initial negative small bowel evaluations and ongoing overt or occult bleeding.

Incidence and correlates of major bleeding after percutaneous coronary intervention across different clinical presentations.

PubMed

Loh, Joshua P; Pendyala, Lakshmana K; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto A; Waksman, Ron

2014-09-01

Bleeding after percutaneous coronary intervention (PCI) is identified as a strong predictor for adverse events, including mortality. This study aims to compare the incidence and correlates of post-PCI bleeding across different clinical presentations. The study included 23,943 consecutive PCI patients categorized according to their clinical presentation: stable angina pectoris (n = 6,741), unstable angina pectoris (UAP) (n = 5,215), non-ST-segment elevation myocardial infarction (NSTEMI) (n = 8,418), ST-segment elevation myocardial infarction (STEMI) (n = 2,721), and cardiogenic shock (CGS) (n = 848). Severity of clinical presentation was associated with a greater use of preprocedural anticoagulation, glycoprotein IIb/IIIa inhibitors, and intraaortic balloon pump (IABP). TIMI-defined major bleeding increased with increasing severity of clinical presentation: stable angina pectoris, 0.7%; UAP, 1.0%; NSTEMI, 1.6%; STEMI, 4.6%; and CGS, 13.5% (P < .001). On multivariable analysis, CGS (odds ratio [OR], 4.67; 95% CI [2.62-8.34]), STEMI (OR, 3.39; 95% CI [2.07-5.55]), and NSTEMI (OR, 2.00; 95% CI [1.29-3.10]) remained correlated with major bleeding even after adjusting for baseline and procedural differences, whereas UAP did not. The multivariable model also identified the use of IABP, female gender, congestive heart failure, no prior PCI, increased baseline hematocrit, and increased procedure time as correlates for major bleeding. In patients undergoing PCI, the worsening severity of clinical presentation corresponds to an increase in incidence of post-PCI major bleeding. The increased risk with CGS, STEMI, and NSTEMI persisted despite adjusting for more aggressive pharmacotherapy and use of IABP. Careful attention to antithrombotic pharmacotherapy is warranted in this high-risk population. Copyright © 2014 Mosby, Inc. All rights reserved.

One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas.

PubMed

Wedi, Edris; Gonzalez, Susana; Menke, Detlev; Kruse, Elena; Matthes, Kai; Hochberger, Juergen

2016-02-07

To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas. From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula. In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life-threatening upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%). This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.

Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.

PubMed

Lou, Wenhui; Xia, Ying; Xiang, Peng; Zhang, Liangqing; Yu, Xiangyou; Lim, Sam; Xu, Mo; Zhao, Lina; Rydholm, Hans; Traxler, Barry; Qin, Xinyu

2018-04-20

To assess the efficacy and safety of esomeprazole in preventing upper gastrointestinal (GI) bleeding in critically ill Chinese patients, using cimetidine as an active comparator. A pre-specified non-inferiority limit (5%) was used to compare rates of significant upper GI bleeding in this randomized, double-blind, parallel-group, phase 3 study across 27 intensive care units in China. Secondary endpoints included safety and tolerability measures. Patients required mechanical ventilation and had at least one additional risk factor for stress ulcer bleeding. Patients were randomized to receive either active esomeprazole 40 mg, as a 30-min intravenous (IV) infusion twice daily, and an IV placebo cimetidine infusion or active cimetidine 50 mg/h, as a continuous infusion following an initial bolus of 300 mg, and placebo esomeprazole injections, given up to 14 days. Patients were blinded using this double-dummy technique. Of 274 patients, 2.7% with esomeprazole and 4.6% with cimetidine had significant upper GI bleeding (bright red blood in the gastric tube not clearing after lavage or persistent Gastroccult-positive "coffee grounds" material). Non-inferiority of esomeprazole to cimetidine was demonstrated. The safety profiles of both drugs were similar and as expected in critically ill patients. Esomeprazole is effective in preventing upper GI bleeding in critically ill Chinese patients, as demonstrated by the non-inferiority analysis using cimetidine as an active control. ClinicalTrials.gov identifier NCT02157376.

A pilot, randomised controlled trial of a rotational thromboelastometry-based algorithm to treat bleeding episodes in extracorporeal life support: the TEM Protocol in ECLS Study (TEMPEST).

PubMed

Buscher, Hergen; Zhang, David; Nair, Priya

2017-10-01

Minimal evidence to guide haemostatic therapy for bleeding in extracorporeal life support (ECLS) has resulted in wide variability in practice. We aimed to show that a goal-directed algorithm incorporating results from thromboelastometry (TEM) is feasible and safe for the timely management of bleeding episodes in adult patients receiving ECLS. A pilot randomised controlled trial involving 16 adult patients who underwent ECLS, randomised over 10 months. The intervention group was treated according to a goal-directed algorithm based on TEM results during bleeding episodes. Apart from the intervention, both groups received standard care including conventional laboratory coagulation tests. Need for blood product transfusion, haemorrhagic and thromboembolic complications and survival. There was a statistically non-significant trend towards reduction in the amount of blood products transfused, occurrence of bleeding, and thrombotic complications, when comparing the intervention arm with the control arm. Survival to hospital discharge was 69%. A significant correlation was found between fibrinogen levels and FIBTEM clot firmness at 10 minutes (R = 0.812; P < 0.001); activated partial thromboplastin time and clotting time HEPTEM/INTEM ratio (R = -0.719; P < 0.001); and platelet count and EXTEM clot firmness at 10 minutes (R = 0.783; P < 0.001). TEM allows assessment for coagulation status in a timely manner and its use for the treatment of bleeding episodes in adult patients receiving ECLS appears feasible and safe. Clinical benefit should be investigated in larger multicentre randomised trials.

Plug-Assisted Retrograde Transvenous Obliteration for the Treatment of Gastric Variceal Hemorrhage.

PubMed

Chang, Min-Yung; Kim, Man-Deuk; Kim, Taehwan; Shin, Wonseon; Shin, Minwoo; Kim, Gyoung Min; Won, Jong Yun; Park, Sung Il; Lee, Do Yun

2016-01-01

To evaluate the feasibility, safety, and clinical outcomes of plug-assisted retrograde transvenous obliteration (PARTO) to treat gastric variceal hemorrhage in patients with portal hypertension. From May 2012 to June 2014, 19 patients (11 men and 8 women, median age; 61, with history of gastric variceal hemorrhage; 17, active bleeding; 2) who underwent PARTO using a vascular plug and a gelfoam pledget were retrospectively analyzed. Clinical and laboratory data were examined to evaluate primary (technical and clinical success, complications) and secondary (worsening of esophageal varix [EV], change in liver function) end points. Median follow-up duration was 11 months, from 6.5 to 18 months. The Wilcoxon signed-rank test was used to compare laboratory data before and after the procedure. Technical success (complete occlusion of the efferent shunt and complete filling of gastric varix [GV] with a gelfoam slurry) was achieved in 18 of 19 (94.7%) patients. The embolic materials could not reach the GV in 1 patient who had endoscopic glue injection before our procedure. The clinical success rate (no recurrence of gastric variceal bleeding) was the same because the technically failed patient showed recurrent bleeding later. Acute complications included fever (n = 2), fever and hypotension (n = 2; one diagnosed adrenal insufficiency), and transient microscopic hematuria (n = 3). Ten patients underwent follow-up endoscopy; all exhibited GV improvement, except 2 without endoscopic change. Five patients exhibited aggravated EV, and 2 of them had a bleeding event. Laboratory findings were significantly improved after PARTO. PARTO is technically feasible, safe, and effective for gastric variceal hemorrhage in patients with portal hypertension.

Clinical outcomes of patients with diabetes and atrial fibrillation treated with apixaban: results from the ARISTOTLE trial.

PubMed

Ezekowitz, Justin A; Lewis, Basil S; Lopes, Renato D; Wojdyla, Daniel M; McMurray, John J V; Hanna, Michael; Atar, Dan; Cecilia Bahit, M; Keltai, Matyas; Lopez-Sendon, Jose L; Pais, Prem; Ruzyllo, Witold; Wallentin, Lars; Granger, Christopher B; Alexander, John H

2015-04-01

We compared clinical outcomes in patients with AF with and without diabetes in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. The main efficacy endpoints were SSE and mortality; safety endpoints were major and major/clinically relevant non-major bleeding. A total of 4547/18 201 (24.9%) patients had diabetes who were younger (69 vs. 70 years), more had coronary artery disease (39 vs. 31%), and higher mean CHADS2 (2.9 vs. 1.9) and HAS-BLED scores (1.9 vs. 1.7) (all P < 0.0001) than patients without diabetes. Patients with diabetes receiving apixaban had lower rates of SSE [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.53-1.05), all-cause mortality (HR 0.83, 95% CI 0.67-1.02), cardiovascular mortality (HR 0.89, 95% CI 0.66-1.20), intra-cranial haemorrhage (HR 0.49, 95% CI 0.25-0.95), and a similar rate of myocardial infarction (HR 1.02, 95% CI 0.62-1.67) compared with warfarin. For major bleeding, a quantitative interaction was seen (P-interaction = 0.003) with a greater reduction in major bleeding in patients without diabetes even after multivariable adjustment. Other measures of bleeding showed a consistent reduction with apixaban compared with warfarin without a significant interaction based on diabetes status. Apixaban has similar benefits on reducing stroke, decreasing mortality, and causing less intra-cranial bleeding than warfarin in patients with and without diabetes. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Association of the 98T ELAM-1 polymorphism with increased bleeding after cardiac surgery.

PubMed

Welsby, Ian J; Podgoreanu, Mihai V; Phillips-Bute, Barbara; Morris, Richard; Mathew, Joseph P; Smith, Peter K; Newman, Mark F; Schwinn, Debra A; Stafford-Smith, Mark

2010-06-01

Hemorrhage continues to be a major problem after cardiac surgery despite the routine use of antifibrinolytic drugs, with striking inter-patient variability poorly explained by already known risk factors. The authors tested the hypothesis that genetic polymorphisms of inflammatory mediators and cellular adhesion molecules are associated with bleeding after cardiac surgery. Prospective, observational study. Single, tertiary referral university heart center. Adult patients undergoing aortocoronary surgery with cardiopulmonary bypass. Patients (n = 759) had 10 mL of blood drawn preoperatively and genomic DNA isolated then genotyped for 17 polymorphisms in 7 candidate genes: tumor necrosis factor, interleukins 1beta and 6, interleukin 1 receptor antagonist, intercellular adhesion molecule-1 (ICAM-1), P-selectin and endothelial leucocyte adhesion molecule-1 (E-selectin). Multivariate analyses were used to relate clinical and genetic factors to bleeding and transfusion. The 98G/T polymorphism of the E-selectin gene was independently associated with bleeding after cardiac surgery (p = 0.002), after adjusting for significant clinical predictors (patient size and baseline hemoglobin concentration). There was a gene dose effect according to the number of minor alleles in the genotype; carriers of the minor allele bled 17% (GT) and 54% (TT) more than wild type (GG) genotypes, respectively (p = 0.01). Carriers of the minor allele also had longer activated partial thromboplastin times (p = 0.0023) and increased fresh frozen plasma transfusion (p = 0.03) compared with wild type. The authors found a dose-related association between the 98T E-selectin polymorphism and bleeding after cardiac surgery, independent of and additive to standard clinical risk factors. Copyright 2010 Elsevier Inc. All rights reserved.

Congenital factor V deficiency: comparison of the severity of clinical presentations among patients with rare bleeding disorders.

PubMed

Naderi, Majid; Tabibian, Shadi; Alizadeh, Shaban; Hosseini, Soudabeh; Zaker, Farhad; Bamedi, Taregh; Shamsizadeh, Morteza; Dorgalaleh, Akbar

2015-01-01

Factor V deficiency (FVD) is a rare bleeding disorder (RBD) mostly present in regions with a high rate of consanguinity. FVD after FXIII deficiency is the next more prevalent RBD in Sistan and Baluchistan (S&B) in southeastern Iran. The aim of this study was to evaluate the clinical manifestations and severity of bleeding diathesis in patients with FVD. This descriptive study was conducted on 23 patients with FVD in S&B province. FVD was diagnosed by clinical findings and routine laboratory tests. Bleeding diatheses were classified into three grades (I-III) depending on the severity of symptoms. The severity of bleeding episodes in our patients was compared with other RBDs. Based on residual plasma FV activity, 6 (26%), 16 (69.5%) and 1 (4.5%) patients had mild, moderate and severe factor deficiency, respectively. 24% of the patients had grade III life-threatening bleeding episodes which in comparison with FVII deficiency (17.4%) and FI deficiency (21%) had a higher incidence, and in comparison with FX deficiency (41.7%) and FXIII deficiency (63.1) had a lower incidence. Grade II and grade I bleeding diathesis were observed in 56.2 and 16.7% of the patients, respectively. FVD is the second most common type of RBD in S&B province and grade II bleeding episodes were the major bleeding presentation and observed in more than half of the patients. © 2014 S. Karger AG, Basel.

The FIGO systems for nomenclature and classification of causes of abnormal uterine bleeding in the reproductive years: who needs them?

PubMed

Munro, Malcolm G; Critchley, Hilary O D; Fraser, Ian S

2012-10-01

In November 2010, the International Federation of Gynecology and Obstetrics formally accepted a new classification system for causes of abnormal uterine bleeding in the reproductive years. The system, based on the acronym PALM-COEIN (polyps, adenomyosis, leiomyoma, malignancy and hyperplasia-coagulopathy, ovulatory disorders, endometrial causes, iatrogenic, not classified) was developed in response to concerns about the design and interpretation of basic science and clinical investigation that relates to the problem of abnormal uterine bleeding. A system of nomenclature for the description of normal uterine bleeding and the various symptoms that comprise abnormal bleeding has also been included. This article describes the rationale, the structured methods that involved stakeholders worldwide, and the suggested use of the International Federation of Gynecology and Obstetrics system for research, education, and clinical care. Investigators in the field are encouraged to use the system in the design of their abnormal uterine bleeding-related research because it is an approach that should improve our understanding and management of this often perplexing clinical condition. Copyright © 2012. Published by Mosby, Inc.

Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study.

PubMed

Skolnick, Brett E; Shenouda, Magdy; Khutoryansky, Naum M; Pusateri, Anthony E; Gabriel, Don; Carr, Marcus E

2011-10-01

Clopidogrel (Plavix®) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven®) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding. In this single-center, randomized, placebo-controlled, double-blind, dose-escalation, exploratory phase I trial, we assessed the safety and effects of rFVIIa in reversing clopidogrel-enhanced bleeding in an experimentally induced punch biopsy in healthy subjects. Efficacy assessments included the reversal of bleeding characteristics (bleed duration [BD], the primary end point and blood loss volume [BV] induced by punch biopsy, and thromboelastograph [TEG®] parameters) with rFVIIa or placebo after clopidogrel treatment. A significant number of subjects (56%) had limited response to clopidogrel (defined as ≤30% platelet aggregation inhibition) and were discontinued from study. The remaining subjects continued and had 4 biopsies. Of 40 subjects randomized, 37 were evaluated for efficacy. Clopidogrel treatment increased BD and BV compared with the baseline biopsy. Recombinant FVIIa (10 and 20 μg/kg) significantly mitigated the clopidogrel-induced effects on BV (P = 0.007 and P = 0.001, respectively). Early trial termination limited the evaluation of effects of higher rFVIIa doses. Subgroup analyses of subjects biopsied by the same physician demonstrated significant reduction of clopidogrel-induced BD with 20 μg/kg rFVIIa (P = 0.048). Ex vivo analysis of rFVIIa demonstrated clotting dynamics presented by parameters time to clot onset (TEG®-R) and clot angle (TEG®-A) (P < 0.005). In this clinical study, rFVIIa (10 and 20 μg/kg) reversed the effect of clopidogrel on blood loss.

Benefits of prophylaxis versus on-demand treatment in adolescents and adults with severe haemophilia A: the POTTER study.

PubMed

Tagliaferri, Annarita; Feola, Giulio; Molinari, Angelo Claudio; Santoro, Cristina; Rivolta, Gianna Franca; Cultrera, Dorina Bianca; Gagliano, Fabio; Zanon, Ezio; Mancuso, Maria Elisa; Valdré, Lelia; Mameli, Luciana; Amoresano, Susanna; Mathew, Prasad; Coppola, Antonio

2015-07-01

Rigorous evidence is lacking on long-term outcomes of factor VIII (FVIII) prophylaxis initiated in adolescent or adult patients with severe haemophilia A. The prospective, open-label Prophylaxis versus On-demand Therapy Through Economic Report (POTTER) study (ClinicalTrials.gov NCT01159587) compared long-term late secondary prophylaxis (recombinant FVIII-FS 20-30 IU/kg thrice weekly) with on-demand treatment in patients aged 12 to 55 years with severe haemophilia A. The annual number of joint bleeding episodes (primary endpoint), total bleeding episodes, orthopaedic and radiologic (Pettersson) scores, health-related quality of life (HRQoL), pharmacoeconomic impact, and safety were evaluated over a > 5-year period (2004-2010). Fifty-eight patients were enrolled at 11 centres in Italy; 53 (27 prophylaxis, 26 on demand) were evaluated and stratified into 2 age subgroups (12-25 and 26-55 years). Patients receiving prophylaxis experienced a significantly lower number of joint bleeding episodes vs the on-demand group (annualised bleeding rate, 1.97 vs 16.80 and 2.46 vs 16.71 in younger and older patients, respectively; p=0.0043). Results were similar for total bleeding episodes. Prophylaxis was associated with significantly fewer target joints (p< 0.001), better orthopaedic (p=0.0019) and Pettersson (p=0.0177) scores, better HRQoL, and fewer days of everyday activities lost (p< 0.0001) but required significantly higher FVIII product consumption. The POTTER study is the first prospective, controlled trial documenting long-term benefits of late secondary prophylaxis in adolescents and adults with severe haemophilia A. The benefits of reduced bleeding frequency, improved joint status, and HRQoL may offset the higher FVIII consumption and costs.

The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study.

PubMed

Hijazi, Ziad; Oldgren, Jonas; Lindbäck, Johan; Alexander, John H; Connolly, Stuart J; Eikelboom, John W; Ezekowitz, Michael D; Held, Claes; Hylek, Elaine M; Lopes, Renato D; Siegbahn, Agneta; Yusuf, Salim; Granger, Christopher B; Wallentin, Lars

2016-06-04

The benefit of oral anticoagulation in atrial fibrillation is based on a balance between reduction in ischaemic stroke and increase in major bleeding. We aimed to develop and validate a new biomarker-based risk score to improve the prognostication of major bleeding in patients with atrial fibrillation. We developed and internally validated a new biomarker-based risk score for major bleeding in 14,537 patients with atrial fibrillation randomised to apixaban versus warfarin in the ARISTOTLE trial and externally validated it in 8468 patients with atrial fibrillation randomised to dabigatran versus warfarin in the RE-LY trial. Plasma samples for determination of candidate biomarker concentrations were obtained at randomisation. Major bleeding events were centrally adjudicated. The predictive values of biomarkers and clinical variables were assessed with Cox regression models. The most important variables were included in the score with weights proportional to the model coefficients. The ARISTOTLE and RE-LY trials are registered with ClinicalTrials.gov, numbers NCT00412984 and NCT00262600, respectively. The most important predictors for major bleeding were the concentrations of the biomarkers growth differentiation factor-15 (GDF-15), high-sensitivity cardiac troponin T (cTnT-hs) and haemoglobin, age, and previous bleeding. The ABC-bleeding score (age, biomarkers [GDF-15, cTnT-hs, and haemoglobin], and clinical history [previous bleeding]) score yielded a higher c-index than the conventional HAS-BLED and the newer ORBIT scores for major bleeding in both the derivation cohort (0·68 [95% CI 0·66-0·70] vs 0·61 [0·59-0·63] vs 0·65 [0·62-0·67], respectively; ABC-bleeding vs HAS-BLED p<0·0001 and ABC-bleeding vs ORBIT p=0·0008). ABC-bleeding score also yielded a higher c-index score in the the external validation cohort (0·71 [95% CI 0·68-0·73] vs 0·62 [0·59-0·64] for HAS-BLED vs 0·68 [0·65-0·70] for ORBIT; ABC-bleeding vs HAS-BLED p<0·0001 and ABC-bleeding vs ORBIT p=0·0016). A modified ABC-bleeding score using alternative biomarkers (haematocrit, cTnI-hs, cystatin C, or creatinine clearance) also outperformed the HAS-BLED and ORBIT scores. The ABC-bleeding score, using age, history of bleeding, and three biomarkers (haemoglobin, cTn-hs, and GDF-15 or cystatin C/CKD-EPI) was internally and externally validated and calibrated in large cohorts of patients with atrial fibrillation receiving anticoagulation therapy. The ABC-bleeding score performed better than HAS-BLED and ORBIT scores and should be useful as decision support on anticoagulation treatment in patients with atrial fibrillation. BMS, Pfizer, Boehringer Ingelheim, Roche Diagnostics. Copyright © 2016 Elsevier Ltd. All rights reserved.

Analysis of clinical negligence claims following tonsillectomy in England 1995 to 2010.

PubMed

Mathew, Rajeev; Asimacopoulos, Eleni; Walker, David; Gutierrez, Tatiana; Valentine, Peter; Pitkin, Lisa

2012-05-01

We determined the characteristics of medical negligence claims following tonsillectomy. Claims relating to tonsillectomy between 1995 and 2010 were obtained from the National Health Service Litigation Authority database. The number of open and closed claims was determined, and data were analyzed for primary injury claimed, outcome of claim, and associated costs. Over 15 years, there were 40 claims of clinical negligence related to tonsillectomy, representing 7.7% of all claims in otolaryngology. There were 34 closed claims, of which 32 (94%) resulted in payment of damages. Postoperative bleeding was the most common injury, with delayed recognition and treatment of bleeding alleged in most cases. Nasopharyngeal regurgitation as a result of soft palate fistulas or excessive tissue resection was the next-commonest cause of a claim. The other injuries claimed included dentoalveolar injury, bums, tonsillar remnants, and temporomandibular joint dysfunction. Inadequate informed consent was claimed in 5 cases. Clinical negligence claims following tonsillectomy have a high success rate. Although postoperative bleeding is the most common cause of negligence claims, a significant proportion of claims are due to rare complications of surgery. Informed consent should be tailored to the individual patient and should include a discussion of common and serious complications.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

Twice-Daily Enoxaparin among Plastic Surgery Inpatients: An Examination of Pharmacodynamics, 90-Day Venous Thromboembolism, and 90-Day Bleeding.

PubMed

Pannucci, Christopher J; Fleming, Kory I; Momeni, Arash; Prazak, Ann Marie; Agarwal, Jayant; Rockwell, W Bradford

2018-06-01

Low anti-factor Xa level, indicative of inadequate enoxaparin dosing, has a significant association with 90-day venous thromboembolism events. The authors examined the pharmacodynamics of enoxaparin 40 mg twice daily and its correlation with anti-factor Xa level, postoperative venous thromboembolism, and bleeding. Adult patients were admitted after plastic and reconstructive surgery and received enoxaparin 40 mg twice daily. Peak anti-factor Xa levels, which quantify enoxaparin's antithrombotic effect, were drawn, with a goal level of 0.2 to 0.4 IU/ml. Ninety-day symptomatic venous thromboembolism and clinically relevant bleeding were identified. The authors enrolled 118 patients who received enoxaparin 40 mg twice daily. Of these patients, 9.6 percent had low peak anti-factor Xa levels (<0.2 IU/ml), 62.6 percent had in-range peak anti-factor Xa levels (0.2 to 0.4 IU/ml), and 27.8 percent had high anti-factor Xa levels (>0.4 IU/ml). With enoxaparin 40 mg twice daily, 90.4 percent of patients received at least adequate prophylaxis. Patient weight predicted the rapidity of enoxaparin metabolism. Zero acute 90-day venous thromboembolism occurred. Eight patients (6.8 percent) had clinically relevant 90-day bleeding: clinical consequences ranged from cessation of enoxaparin prophylaxis to transfusion to operative hematoma evacuation. When enoxaparin 40 mg twice daily is provided, 90 percent of patients receive at least adequate venous thromboembolism prophylaxis (anti-factor Xa level >0.2 IU/ml). However, 27 percent of the overall population is overtreated (anti-factor Xa level >0.4 IU/ml). These pharmacodynamics data likely explain the low rate of 90-day acute venous thromboembolism (0 percent) and the high rate of clinically relevant bleeding (6.8 percent) observed. Future studies are needed to better optimize the risks and benefits of enoxaparin prophylaxis in plastic and reconstructive surgery patients. Therapeutic, IV.

Distinctive aspects of peptic ulcer disease, Dieulafoy's lesion, and Mallory-Weiss syndrome in patients with advanced alcoholic liver disease or cirrhosis

PubMed Central

Nojkov, Borko; Cappell, Mitchell S

2016-01-01

AIM: To systematically review the data on distinctive aspects of peptic ulcer disease (PUD), Dieulafoy’s lesion (DL), and Mallory-Weiss syndrome (MWS) in patients with advanced alcoholic liver disease (aALD), including alcoholic hepatitis or alcoholic cirrhosis. METHODS: Computerized literature search performed via PubMed using the following medical subject heading terms and keywords: “alcoholic liver disease”, “alcoholic hepatitis”,“ alcoholic cirrhosis”, “cirrhosis”, “liver disease”, “upper gastrointestinal bleeding”, “non-variceal upper gastrointestinal bleeding”, “PUD”, ‘‘DL’’, ‘‘Mallory-Weiss tear”, and “MWS’’. RESULTS: While the majority of acute gastrointestinal (GI) bleeding with aALD is related to portal hypertension, about 30%-40% of acute GI bleeding in patients with aALD is unrelated to portal hypertension. Such bleeding constitutes an important complication of aALD because of its frequency, severity, and associated mortality. Patients with cirrhosis have a markedly increased risk of PUD, which further increases with the progression of cirrhosis. Patients with cirrhosis or aALD and peptic ulcer bleeding (PUB) have worse clinical outcomes than other patients with PUB, including uncontrolled bleeding, rebleeding, and mortality. Alcohol consumption, nonsteroidal anti-inflammatory drug use, and portal hypertension may have a pathogenic role in the development of PUD in patients with aALD. Limited data suggest that Helicobacter pylori does not play a significant role in the pathogenesis of PUD in most cirrhotic patients. The frequency of bleeding from DL appears to be increased in patients with aALD. DL may be associated with an especially high mortality in these patients. MWS is strongly associated with heavy alcohol consumption from binge drinking or chronic alcoholism, and is associated with aALD. Patients with aALD have more severe MWS bleeding and are more likely to rebleed when compared to non-cirrhotics. Pre-endoscopic management of acute GI bleeding in patients with aALD unrelated to portal hypertension is similar to the management of aALD patients with GI bleeding from portal hypertension, because clinical distinction before endoscopy is difficult. Most patients require intensive care unit admission and attention to avoid over-transfusion, to correct electrolyte abnormalities and coagulopathies, and to administer antibiotic prophylaxis. Alcoholics should receive thiamine and be closely monitored for symptoms of alcohol withdrawal. Prompt endoscopy, after initial resuscitation, is essential to diagnose and appropriately treat these patients. Generally, the same endoscopic hemostatic techniques are used in patients bleeding from PUD, DL, or MWS in patients with aALD as in the general population. CONCLUSION: Nonvariceal upper GI bleeding in patients with aALD has clinically important differences from that in the general population without aALD, including: more frequent and more severe bleeding from PUD, DL, or MWS. PMID:26755890

Curative effects of two new endometrial ablation procedures using radiofrequency thermocoagulation for the treatment of severe abnormal uterine bleeding.

PubMed

Yin, Geping; Li, Juan; Zhu, Tongyu; Chen, Ming

2013-07-01

Severe Abnormal Uterine Bleeding (SAUB) is a common gynecological disorder. The clinical characteristics include disordered menstrual cycle and massive bleeding that can cause anemia or secondary infection. Current treatment mainly relies on drug therapy or surgical removal of the uterus, each having its significant disadvantages. How to preserve the uterus, reduce the pain from surgery, and achieve better treatment effects have been well known but remaining as unresolved issues. This study aims at evaluating two types of radiofrequency (RF) thermocoagulation procedures for the treatment of SAUB: the RF-A procedure group included 25 SAUB patients ≥45 years of age treated for amenorrhea; the RF-B procedure group included 51 patients at <45 years of age treated for the control of excessive bleeding. Post-treatment ratings of menstrual satisfaction and pre-/post-treatment menstrual scores-pictorial blood loss assessment chart (PBAC)-and hemoglobin levels were collected; and the mean length of follow-up was 72 months. Also, 38 SAUB patients treated with standard drug regimens served as a control group. The results of the study showed that following RF treatment, the average long-term patient menstrual satisfaction was greater than 92 %. In both the RF groups, PBAC scores and hemoglobin levels were significantly improved from baseline (p < .05). Compared with the control group, PBAC scores and hemoglobin levels were also significantly better for the RF groups at 6-24-month post-operation. Patients experienced no hysterectomy in association with the RF procedures. In conclusion, this pilot study suggests that the novel RF procedures are both safe and effective in treating patients with SAUB. Further investigation is necessary to evaluate their application in broader clinical indication.

Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in people with liver diseases. One of them is vitamin K administration, but it is not known whether it benefits or harms people with acute or chronic liver disease and upper gastrointestinal bleeding. This is an update of this Cochrane review. To assess the beneficial and harmful effects of vitamin K for people with acute or chronic liver disease and upper gastrointestinal bleeding. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), and LILACS (1982 to 25 February 2015). We sought additional randomised trials from two registries of clinical trials: the World Health Organization Clinical Trials Search Portal and the metaRegister of Controlled Trials. We looked through the reference lists of the retrieved publications and review articles. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. We considered observational studies for assessment of harms only. \\We aimed to summarise data from randomised clinical trials using Standard Cochrane methodology and assess them according to the GRADE approach. We found no randomised trials on vitamin K for upper gastrointestinal bleeding in people with liver diseases assessing benefits and harms of the intervention. We identified no quasi-randomised studies, historically controlled studies, or observational studies assessing harms. This updated review found no randomised clinical trials of vitamin K for upper gastrointestinal bleeding in people with liver diseases. The benefits and harms of vitamin K need to be tested in randomised clinical trials. Until randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases.

Post-tonsillectomy hemorrhagic outcomes in children with bleeding disorders at a single institution.

PubMed

Patel, Priyesh N; Arambula, Alexandra M; Wheeler, Allison P; Penn, Edward B

2017-09-01

To report on the post-tonsillectomy bleeding outcomes and factors associated with hemorrhage among children with pre- or post-operatively diagnosed bleeding disorders treated with an institutional protocol. Retrospective cohort study of patients with hematologic disorders who underwent tonsillectomy between 2003 and 2016 and were treated with perioperative desmopressin or factor replacement and/or aminocaproic acid. Postoperative outcomes were compared to controls matched for age, sex, and indication for surgery. Analysis of factors associated with hemorrhage was performed in patients with bleeding disorders using Mann-Whitney U or chi-squared tests. 45 patients with hematologic disorders met inclusion criteria. Platelet dysfunction, including von Willebrand Disease (vWD), was the most common diagnosis (77.8%). Most patients had a preoperative diagnosis of a bleeding disorder and received perioperative hematologic medications (86.7%). Compared to matched controls, patients with hematologic disorders experienced more postoperative bleeding (15.5%; 12 bleeds, 7 patients vs. 1.7%; 1 bleed, 1 patient, p = 0.05) and had longer postoperative stays (1.3 days vs. 0.4 days, p < 0.001). Among the patients with hematologic disorders, patients who experienced a postoperative bleed were significantly more likely to have a factor deficiency (e.g. Hemophilia over vWD) and have a postoperative diagnosis (compared to preoperative diagnosis) for which they did not receive perioperative hematologic medication. Of patients with a postoperative bleed, all those diagnosed postoperatively required at least one surgical intervention to control bleeding compared to 33% of patients with a preoperative diagnosis. A history of post-surgical bleeding, male sex, age at surgery, and pharyngitis as surgical indication were not associated with higher hemorrhage rates in this group. This study suggests a clinically important magnitude of increased bleeding risk in patients with hematologic disease. This risk appears to decrease with the use of an institutional protocol consisting of desmopressin or factor replacement and an antifibrinolytic agent extending through postoperative day 10. Copyright © 2017 Elsevier B.V. All rights reserved.

Common management issues in pediatric patients with mild bleeding disorders.

PubMed

O'Brien, Sarah H

2012-10-01

Type 1 von Willebrand disease and mild platelet function defects are among the most common disorders seen by pediatric hematologists. The management and prevention of bleeding in these patients can be challenging, as there are limited published data to guide clinical practice, and a complete lack of randomized clinical trials. Desmopressin (DDAVP) and antifibrinolytics are the mainstays of treatment in these patients, yet the optimal dosing and timing of these agents to prevent or resolve bleeding, while minimizing adverse side effects, is sometimes unclear. DDAVP-induced hyponatremia is a particularly under-recognized complication in children with bleeding disorders who undergo surgery. Clinicians need to be aware of local measures that are equally important in treating problems such as epistaxis and surgical bleeding. This review will discuss the published literature and provide practical suggestions regarding four common management issues in the care of children and adolescents with mild bleeding disorders: epistaxis, heavy menstrual bleeding, dental extractions, and tonsillectomy. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Transcatheter arterial embolization for upper gastrointestinal tract bleeding

PubMed Central

Širvinskas, Audrius; Smolskas, Edgaras; Brimienė, Vilma; Brimas, Gintautas

2017-01-01

Introduction Transcatheter arterial embolization is a possible treatment for patients with recurrent bleeding from the upper gastrointestinal tract after failed endoscopic management and is also an alternative to surgical treatment. Aim To analyze the outcomes of transcatheter arterial embolization and identify the clinical and technical factors that influenced the rates of morbidity and mortality. Material and methods A retrospective analysis was carried out, based on the data of 36 patients who underwent transcatheter arterial embolization for acute nonvariceal upper gastrointestinal bleeding in 2013 to 2015 in our center. An analysis was performed between early rebleeding rates, mortality and the following factors: patient sex, age, number of units of packed red blood cells and packed plasma administered to the patients, length of hospital stay, therapeutic or prophylactic embolization. Results The technical success rate of the embolization procedure was 100%. There were 15 (41.70%) therapeutic embolizations and 21 (58.3%) prophylactic embolizations. There was a 77.8% clinical success rate. Following embolization, 10 (27.80%) patients had repeated bleeding and 9 (25.0%) patients died. Significant associations were found between rebleeding and prophylactic embolization (OR = 10.53; p = 0.04) and between mortality and prophylactic embolization (OR = 10.53; p = 0.04) and units of packed red blood cells (OR = 1.25; p < 0.01). Conclusions In our experience, transcatheter arterial embolization is a safe treatment method for acute nonvariceal upper gastrointestinal bleeding and a possible alternative to surgery for high-risk patients. PMID:29362654

Natural history of patients with non cirrhotic portal hypertension: Comparison with patients with compensated cirrhosis.

PubMed

Gioia, Stefania; Nardelli, Silvia; Pasquale, Chiara; Pentassuglio, Ilaria; Nicoletti, Valeria; Aprile, Francesca; Merli, Manuela; Riggio, Oliviero

2018-01-31

The knowledge of natural history of patients with portal hypertension (PH) not due to cirrhosis is less well known than that of cirrhotic patients. To describe the clinical presentation and the outcomes of 89 patients with non-cirrhotic PH (25 with non-cirrhotic portal hypertension, INCPH, and 64 with chronic portal vein thrombosis, PVT) in comparison with 77 patients with Child A cirrhosis. The patients were submitted to a standardized clinical, laboratory, ultrasonographic and endoscopic follow-up. Variceal progression, incidence of variceal bleeding, portal vein thrombosis, ascites and survival were recorded. At presentation, the prevalence of varices, variceal bleeding and ascites was similar in the 3 groups. During follow-up, the rate of progression to varices at risk of bleeding (p < 0.0001) and the incidence of first variceal bleeding (p = 0.02) were significantly higher in non-cirrhotic then in cirrhotic patients. A PVT developed in 32% of INCPH patients and in 18% of cirrhotics (p = 0.02). In the patients with non-cirrhotic PH variceal progression is more rapid and bleeding more frequent than in cirrhotics. Patients with INCPH are particularly prompt to develop PVT. This observational study suggests that the management of patients with non-cirrhotic PH should take into consideration the natural history of portal hypertension in these patients and cannot be simply derived by the observation of cirrhotic patients. Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Mortality from nonulcer bleeding is similar to that of ulcer bleeding in high-risk patients with nonvariceal hemorrhage: a prospective database study in Italy.

PubMed

Marmo, Riccardo; Del Piano, Mario; Rotondano, Gianluca; Koch, Maurizio; Bianco, Maria Antonia; Zambelli, Alessandro; Di Matteo, Giovanni; Grossi, Enzo; Cipolletta, Livio; Prometeo Investigators

2012-02-01

Nonulcer causes of bleeding are often regarded as minor, ie, associated with a lower risk of mortality. To assess the risk of death from nonulcer causes of upper GI bleeding (UGIB). Secondary analysis of prospectively collected data from 3 national databases. Community and teaching hospitals. Consecutive patients admitted for acute nonvariceal UGIB. Early endoscopy, medical and endoscopic treatment as appropriate. Thirty-day mortality, recurrent bleeding, and need for surgery. A total of 3207 patients (65.8% male), mean (standard deviation) age 68.3 (16.4) years, were analyzed. Overall mortality was 4.45% (143 patients). According to the source of bleeding, mortality was 9.8% for neoplasia, 4.8% for Mallory-Weiss tears, 4.8% for vascular lesions, 4.4% for gastroduodenal erosions, 4.4% for duodenal ulcer, and 3.1% for gastric ulcer. Frequency of death was not different among benign endoscopic diagnoses (overall P = .567). Risk of death was significantly higher in patients with neoplasia compared with benign conditions (odds ratio 2.50; 95% CI, 1.32-4.46; P < .0001). Gastric or duodenal ulcer significantly increased the risk of death, but this was not related to the presence of high-risk stigmata (P = .368). The strongest predictor of mortality for all causes of nonvariceal UGIB was the overall physical status of the patient measured with the American Society of Anesthesiologists score (1-2 vs 3-4, P < .001). No data on the American Society of Anesthesiologists class score in the Prometeo study. Nonulcer causes of nonvariceal UGIB have a risk of death, similar to bleeding peptic ulcers in the clinical context of a high-risk patient. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Bleeding score in type 1 von Willebrand disease patients using the condensed MCMDM-1 vWD validated questionnaire.

PubMed

Pathare, A; Al Hajri, F; Al Omrani, S; Al Obaidani, N; Al Balushi, B; Al Falahi, K

2018-05-13

Assessment of the severity of bleeding symptom has led to the evolution of bleeding assessment tools which are now validated. To administer the condensed molecular and clinical markers for the diagnosis and management of type 1 von Willebrand disease VWD (MCMDM-1 vWD) questionnaire to the Omani type 1 vWD patients and correlate it with the laboratory parameters. Patients and controls were personally interviewed and the condensed MCMDM-1 vWD questionnaire administered by a single investigator. Bleeding score (BS) was calculated, based on the presence or absence of the bleeding symptoms according to a standard validated questionnaire in both the patients and the controls. The median age of the patient cohort was 27 (range, 7-49) years with 60.87% of females. The median time to administer condensed MCMDM-1 BS questionnaire was 11 minutes (interquartile range-IQR;7,16). Overall, bleeding from the oral cavity was the most predominant symptom (63%). The median BS was 5 (IQR;1,8) although individual scores ranged between 0 and 29. However, there was no statistically significant difference in BS between genders (males: median 4; IQR 1,6 and females: median 5, IQR 1,10) (P > .05, Kruskal-Wallis test) The Spearman's correlation value of BS was weak with FVIII:C levels and von Willebrand Ristocetin co-factor activity; very weak with von Willebrand Antigen level, and moderate with vonWillebrand Collagen Binding activity being -0.29, -0.28, -0.14 and -0.43, respectively. The BS reflects the severity of bleeding among the vWD patients. Although the BS was abnormal, it did not correlate significantly with the surrogate laboratory parameters [P > .05]. © 2018 John Wiley & Sons Ltd.

The effect of locally delivered doxycycline as an adjunctive therapy to scaling and root planing in smokers

PubMed Central

Al Hulami, Hassan; Babay, Nadir; Awartani, Fatin; Anil, Sukumaran

2011-01-01

Background Locally delivered doxycycline is found to be effective in managing periodontitis as an adjunct to scaling and root planing. Aim To evaluate the effect of locally delivered doxycycline (10%) with scaling and root planing in the periodontal treatment of smokers and to compare it with scaling and root planing alone. Methods Twelve smokers with chronic periodontitis and a pocket depth (⩾5 mm) on posterior teeth that bleed on probing were selected. Patients were randomly assigned to scaling and root planing (SRP) or scaling and root planing followed by local application of doxycycline (SRP-D). Plaque, bleeding on probing, gingival recession, clinical attachment level (CAL), and probing depth (PD) were recorded at the baseline, 6 and 12 weeks. Results Both groups showed a significant reduction in Plaque, Bleeding on Probing and pocket depth at 6th and 12th week from the baseline. A statistically significant gain of attachment was observed in both groups after treatment. Even though the doxycycline group showed slightly higher attachment gain it was not statistically significant compared to the control group. Conclusion The observations of the study reveal that the additional benefit of topical application of doxycycline as an adjunct to scaling and root planing in smokers is not convincing. However, further clinical studies may be necessary to substantiate the present observations. PMID:23960508

A clinically viable capsule endoscopy video analysis platform for automatic bleeding detection

NASA Astrophysics Data System (ADS)

Yi, Steven; Jiao, Heng; Xie, Jean; Mui, Peter; Leighton, Jonathan A.; Pasha, Shabana; Rentz, Lauri; Abedi, Mahmood

2013-02-01

In this paper, we present a novel and clinically valuable software platform for automatic bleeding detection on gastrointestinal (GI) tract from Capsule Endoscopy (CE) videos. Typical CE videos for GI tract run about 8 hours and are manually reviewed by physicians to locate diseases such as bleedings and polyps. As a result, the process is time consuming and is prone to disease miss-finding. While researchers have made efforts to automate this process, however, no clinically acceptable software is available on the marketplace today. Working with our collaborators, we have developed a clinically viable software platform called GISentinel for fully automated GI tract bleeding detection and classification. Major functional modules of the SW include: the innovative graph based NCut segmentation algorithm, the unique feature selection and validation method (e.g. illumination invariant features, color independent features, and symmetrical texture features), and the cascade SVM classification for handling various GI tract scenes (e.g. normal tissue, food particles, bubbles, fluid, and specular reflection). Initial evaluation results on the SW have shown zero bleeding instance miss-finding rate and 4.03% false alarm rate. This work is part of our innovative 2D/3D based GI tract disease detection software platform. While the overall SW framework is designed for intelligent finding and classification of major GI tract diseases such as bleeding, ulcer, and polyp from the CE videos, this paper will focus on the automatic bleeding detection functional module.

Outcome Following a Negative CT Angiogram for Gastrointestinal Hemorrhage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chan, Victoria, E-mail: drvictoriac@gmail.com; Tse, Donald, E-mail: donald.tse@gmail.com; Dixon, Shaheen, E-mail: shaheen7noorani@gmail.com

2015-04-15

ObjectiveThis study was designed to evaluate the role of a negative computed tomography angiogram (CTA) in patients who present with gastrointestinal (GI) hemorrhage.MethodsA review of all patients who had CTAs for GI hemorrhage over an 8-year period from January 2005 to December 2012 was performed. Data for patient demographics, location of hemorrhage, hemodynamic stability, and details of angiograms and/or the embolization procedure were obtained from the CRIS/PACS database, interventional radiology database, secure electronic medical records, and patient’s clinical notes.ResultsA total of 180 patients had 202 CTAs during the 8-year period: 87 CTAs were performed for upper GI hemorrhage (18 positivemore » for active bleeding, 69 negative) and 115 for lower GI hemorrhage (37 positive for active bleeding, 78 negative); 58.7 % (37/63) of patients with upper GI bleed and 77.4 % (48/62) of patients with lower GI bleed who had an initial negative CTA did not rebleed without the need for radiological or surgical intervention. This difference was statistically significant (p = 0.04). The relative risk of rebleeding, following a negative CTA, in lower GI bleeding versus upper GI bleeding patients is 0.55 (95 % confidence interval 0.32–0.95).ConclusionsPatients with upper GI bleed who had negative CTAs usually require further intervention to stop the bleeding. In contrast, most patients presenting with lower GI hemorrhage who had a negative first CTA were less likely to rebleed.« less

Telemetric real-time sensor for the detection of acute upper gastrointestinal bleeding.

PubMed

Schostek, Sebastian; Zimmermann, Melanie; Keller, Jan; Fode, Mario; Melbert, Michael; Schurr, Marc O; Gottwald, Thomas; Prosst, Ruediger L

2016-04-15

Acute upper gastrointestinal bleedings from ulcers or esophago-gastric varices are life threatening medical conditions which require immediate endoscopic therapy. Despite successful endoscopic hemostasis, there is a significant risk of rebleeding often requiring close surveillance of these patients in the intensive care unit (ICU). Any time delay to recognize bleeding may lead to a high blood loss and increases the risk of death. A novel telemetric real-time bleeding sensor can help indicate blood in the stomach: the sensor is swallowed to detect active bleeding or is anchored endoscopically on the gastrointestinal wall close to the potential bleeding source. By telemetric communication with an extra-corporeal receiver, information about the bleeding status is displayed. In this study the novel sensor, which measures characteristic optical properties of blood, has been evaluated in an ex-vivo setting to assess its clinical applicability and usability. Human venous blood of different concentrations, various fluids, and liquid food were tested. The LED-based sensor was able to reliably distinguish between concentrated blood and other liquids, especially red-colored fluids. In addition, the spectrometric quality of the small sensor (size: 6.5mm in diameter, 25.5mm in length) was comparable to a much larger and technically more complex laboratory spectrophotometer. The experimental data confirm the capability of a miniaturized sensor to identify concentrated blood, which could help in the very near future the detection of upper gastrointestinal bleeding and to survey high-risk patients for rebleeding. Copyright © 2015 Elsevier B.V. All rights reserved.

Dynamics of red fluorescent dental plaque during experimental gingivitis--A cohort study.

PubMed

van der Veen, Monique H; Volgenant, Catherine M C; Keijser, Bart; Ten Cate, Jacob Bob M; Crielaard, Wim

2016-05-01

The dynamics of red fluorescent plaque (RFP) in comparison to clinical plaque and bleeding scores were studied during an experimental gingivitis protocol in a cohort of healthy participants. Forty-one participants were monitored for RFP before (24h plaque), during 14 days plaque accumulation (days 2, 5, 9, 14) and after 7 days recovery (24h plaque). RFP was assessed on fluorescence photographs of the vestibular aspect of the anterior teeth (cuspid to cuspid) in the upper and lower jaw. Clinical plaque and bleeding were assessed at days -14, 0, 14 and 21. RFP of 24h plaque was reproducible (days -14, 0), then increased during 14 days plaque accumulation and returned to baseline after 7 days recovery. Groups of low, moderate and high RFP formers were statistically significantly different at all times even already at baseline. The individual RFP response during 14 days plaque accumulation correlated well with RFP of 24h plaque (days -14, 0). RFP correlated moderate to well with clinical plaque at days -14, 0, 14 and 21. From day 2 of the gingivitis challenge RFP correlated with bleeding at day 14. RFP provided an objective measure of oral hygiene status. Given the correlation with clinical parameters found, the amount of RFP after 24h plaque accumulation was indicatory for the inflammatory response during a prolonged period of no oral hygiene. This trial was registered at the public trial register ​of the Central Committee on Research Involving Human Subjects (CCMO) under number NL51111.029.14 CLINICAL SIGNIFICANCE: This paper shows the association between RFP after 24h plaque accumulation and inflammatory response after a prolonged period of no oral hygiene. Red plaque fluorescence can be used to identify subjects at risk for developing gingival inflammation. Copyright © 2016 Elsevier Ltd. All rights reserved.

Randomized clinical trial of ligasure™ versus conventional splenectomy for injured spleen in blunt abdominal trauma.

PubMed

Amirkazem, Vejdan Seyyed; Malihe, Khosravi

2017-02-01

Spleen is the most common organ damaged in cases of blunt abdominal trauma and splenectomy and splenorrhaphy are the main surgical procedures that are used in surgical treatment of such cases. In routine open splenectomy cases, after laparotomy, application of sutures in splenic vasculature is the most widely used procedure to cease the bleeding. This clinical trial evaluates the role and benefits of the Ligasure™ system in traumatic splenectomy without using any suture materials and compares the result with conventional method of splenectomy. After making decision for splenectomy secondary to a blunt abdominal trauma, patients in control group (39) underwent splenectomy using conventional method with silk suture ligation of splenic vasculature. In the interventional group (41) a Ligasure™ vascular sealing system was used for ligating of the splenic vein and artery. The results of operation time, volume of intra-operation bleeding and post-operative complications were compared in both groups. The mean operation times in control and interventional group were 21 and 12 min respectively (p < 0.05). The average volume of bleeding in control group during open splenectomy was 280 cc, but in the interventional group decreased significantly to 80 ml (p < 0.05) using the Ligasure system. Post-operative complications such as bleeding were non-existent in both groups. The application of Ligasure™ in blunt abdominal trauma for splenectomy not only can decrease the operation time but also can decrease the volume of bleeding during operation without any additional increase in post-operative complications. This method is recommendable in traumatic splenic injuries that require splenectomy in order to control the bleeding as opposed to use of traditional silk sutures. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Evaluation of scoring models for identifying the need for therapeutic intervention of upper gastrointestinal bleeding: A new prediction score model for Japanese patients.

PubMed

Iino, Chikara; Mikami, Tatsuya; Igarashi, Takasato; Aihara, Tomoyuki; Ishii, Kentaro; Sakamoto, Jyuichi; Tono, Hiroshi; Fukuda, Shinsaku

2016-11-01

Multiple scoring systems have been developed to predict outcomes in patients with upper gastrointestinal bleeding. We determined how well these and a newly established scoring model predict the need for therapeutic intervention, excluding transfusion, in Japanese patients with upper gastrointestinal bleeding. We reviewed data from 212 consecutive patients with upper gastrointestinal bleeding. Patients requiring endoscopic intervention, operation, or interventional radiology were allocated to the therapeutic intervention group. Firstly, we compared areas under the curve for the Glasgow-Blatchford, Clinical Rockall, and AIMS65 scores. Secondly, the scores and factors likely associated with upper gastrointestinal bleeding were analyzed with a logistic regression analysis to form a new scoring model. Thirdly, the new model and the existing model were investigated to evaluate their usefulness. Therapeutic intervention was required in 109 patients (51.4%). The Glasgow-Blatchford score was superior to both the Clinical Rockall and AIMS65 scores for predicting therapeutic intervention need (area under the curve, 0.75 [95% confidence interval, 0.69-0.81] vs 0.53 [0.46-0.61] and 0.52 [0.44-0.60], respectively). Multivariate logistic regression analysis retained seven significant predictors in the model: systolic blood pressure <100 mmHg, syncope, hematemesis, hemoglobin <10 g/dL, blood urea nitrogen ≥22.4 mg/dL, estimated glomerular filtration rate ≤ 60 mL/min per 1.73 m 2 , and antiplatelet medication. Based on these variables, we established a new scoring model with superior discrimination to those of existing scoring systems (area under the curve, 0.85 [0.80-0.90]). We developed a superior scoring model for identifying therapeutic intervention need in Japanese patients with upper gastrointestinal bleeding. © 2016 Japan Gastroenterological Endoscopy Society.

Clinical experience with Optivate®, high-purity factor VIII (FVIII) product with von Willebrand factor (VWF) in young children with haemophilia A.

PubMed

Matysiak, M; Bobrowska, H; Balwierz, W; Chybicka, A; Kowalczyk, J R; Shaikh-Zaidi, R; Gillanders, K; Dash, C H

2011-09-01

Optivate® is a high-purity FVIII/VWF product. Its safety, tolerability and efficacy in subjects ≥ 12 years have been demonstrated. This study was undertaken to assess Optivate® in children with haemophilia A. Twenty-five children, including one PUP (previously untreated patient), aged 1-6 years (mean 4.67 years) were treated with Optivate® for 26 weeks. Inhibitors were assessed every 3 months and viral status at the study start and end. Prophylaxis was used by five boys and on demand by twenty. The mean number of bleeds in the study was lower compared to the same period pre-study (12.0/child vs. 16.2/child), with fewer bleeds (P < 0.05) in the prophylactic subgroup (8.0/child) compared with the on-demand sub-group (13.4/child). Fourteen major bleeds were reported, all by the on-demand sub-group. Children on prophylaxis were administered a mean of 59.4 infusions; on-demand group 35.1 infusions. A total of 998 infusions were used with a mean dose of 29.1 IU kg⁻¹, and a mean of 38.6 exposure days (ED). Children < 4 years used higher doses, and reported fewer bleeds than older children. Children's Parents/Guardians rated Optivate® as helpful or very helpful in controlling 97.5% of bleeds by the prophylactic group, and in 98.5% of the bleeds in the on-demand group. Only 5 of 101 ADRs were treatment-related events (5%), all were mild and non-serious. There were no clinically significant changes in vital signs, viral transmissions or inhibitors. In young children Optivate® was well tolerated, safe and efficacious. © 2011 Blackwell Publishing Ltd.

Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators.

PubMed

D'Amico, Gennaro; De Franchis, Roberto

2003-09-01

Several treatments have been proven to be effective for variceal bleeding in patients with cirrhosis. The aim of this multicenter, prospective, cohort study was to assess how these treatments are used in clinical practice and what are the posttherapeutic prognosis and prognostic indicators of upper digestive bleeding in patients with cirrhosis. A training set of 291 and a test set of 174 bleeding cirrhotic patients were included. Treatment was according to the preferences of each center and the follow-up period was 6 weeks. Predictive rules for 5-day failure (uncontrolled bleeding, rebleeding, or death) and 6-week mortality were developed by the logistic model in the training set and validated in the test set. Initial treatment controlled bleeding in 90% of patients, including vasoactive drugs in 27%, endoscopic therapy in 10%, combined (endoscopic and vasoactive) in 45%, balloon tamponade alone in 1%, and none in 17%. The 5-day failure rate was 13%, 6-week rebleeding was 17%, and mortality was 20%. Corresponding findings for variceal versus nonvariceal bleeding were 15% versus 7% (P =.034), 19% versus 10% (P =.019), and 20% versus 15% (P =.22). Active bleeding on endoscopy, hematocrit levels, aminotransferase levels, Child-Pugh class, and portal vein thrombosis were significant predictors of 5-day failure; alcohol-induced etiology, bilirubin, albumin, encephalopathy, and hepatocarcinoma were predictors of 6-week mortality. Prognostic reassessment including blood transfusions improved the predictive accuracy. All the developed prognostic models were superior to the Child-Pugh score. In conclusion, prognosis of digestive bleeding in cirrhosis has much improved over the past 2 decades. Initial treatment stops bleeding in 90% of patients. Accurate predictive rules are provided for early recognition of high-risk patients.

Temporal trend of in-hospital major bleeding among patients with non ST-elevation acute coronary syndromes.

PubMed

Elbarouni, Basem; Elmanfud, Omran; Yan, Raymond T; Fox, Keith A A; Kornder, Jan M; Rose, Barry; Spencer, Frederick A; Welsh, Robert C; Wong, Graham C; Goodman, Shaun G; Yan, Andrew T

2010-09-01

Although randomized controlled trials support the use of intensive medical and invasive therapies for non-ST segment elevation acute coronary syndromes (NSTE-ACS), major bleeding is a serious treatment complication. We sought to determine the temporal trend of in-hospital major bleeding among patients with NSTE-ACS, in relation to the evolving management pattern. We identified 14 111 NSTE-ACS patients enrolled in 4 successive, prospective, multicenter registries (ACS I, 1999-2001; ACS II, 2002-2003; GRACE, 2004-2007; and CANRACE, 2008) in Canada between 1999 and 2008. We collected data on patient characteristics, use of cardiac medications and procedures on standardized case report forms. In all registries, major bleeding was defined a priori as life threatening or fatal bleeding, bleeding requiring transfusion of ≥2 U of packed red cells, or resulting in an absolute decrease in hemoglobin of >30g/L. A total of 14 111 patients had a final diagnosis of NSTE-ACS and were included in this study (3294 in the ACS-I registry, 1956 in the ACS-II registry, 7543 in GRACE, and 1318 in CANRACE). Over time, there was a substantial increase in the use of dual anti-platelet (aspirin and thienopyridine) therapy (P for trend <.001), and in rates of in-hospital cardiac catheterization and percutaneous coronary intervention (both Ps for trend <.001). Overall, major bleeding was relatively infrequent (1.7%). There was no significant increase in the unadjusted rates of major bleeding over time (P for trend = .19). In multivariable analysis adjusting for GRACE risk score and intensive treatment, enrolment period was not an independent predictor of bleeding (P for trend = .98). There was no interaction between the enrolment period and the use of intensive medical and invasive management. Despite more widespread use of dual anti-platelet therapies and invasive cardiac procedures in the management of NSTE-ACS, the rate of major bleeding remains relatively low and has not increased significantly over time. Our findings suggest that physicians selectively target treatment for their patients, and these evidence-based therapies can be safely administered to ACS patients in clinical practice. 2010 Mosby, Inc. All rights reserved.

Pentasaccharides in the prophylaxis and treatment of venous thromboembolism: a systematic review.

PubMed

Nijkeuter, M; Huisman, M V

2004-09-01

The aim of this review is to perform a critical analysis of all completed studies evaluating pentasaccharides-synthetically derived, selective inhibitors of activated factor X-in prophylaxis in major orthopedic surgery and the treatment of venous thromboembolism. Venous thromboembolism is a disorder with considerable morbidity when left untreated. New antithrombotic agents have been developed that selectively inhibit components of the coagulation system, thereby avoiding the difficulties associated with current anticoagulants. The pentasaccharides fondaparinux and idraparinux are the first of a new class of synthetic selective inhibitors of activated factor X. Fondaparinux has been extensively investigated in two areas: orthopedic surgery and venous thromboembolism. It is clear from four thromboprophylaxis studies in major orthopedic surgery that fondaparinux is 50% more effective in reducing venous thromboembolism than enoxaparin. This superior efficacy led to an overall increase in major bleeding, which was however primarily due to more fondaparinux-treated patients with bleeding indexes of 2 or greater. The incidence of fatal bleeding, critical organ bleeding, or bleeding leading to reoperation did not differ significantly between the two groups. In the initial treatment of patients with proximal vein thrombosis and pulmonary embolism, fondaparinux was equally effective as low molecular weight heparins and unfractionated heparin, respectively, without a different incidence in major bleeding in fondaparinux and comparator heparin groups. Fondaparinux, one of the first of a new class of synthetic selective factor Xa inhibitors, is overall 50% more effective in reducing venous thromboembolism than enoxaparin in major orthopedic surgery, with an overall 1% increased rate of major bleeding, when compared with enoxaparin. The incidence of fatal bleeding, critical organ bleeding, or bleeding leading to reoperation did not differ significantly between the two treatment groups. Fondaparinux is equally effective as low molecular weight heparins and unfractionated heparin in the initial treatment of patients with proximal vein thrombosis and pulmonary embolism, respectively. Finally, as with any new drug, fondaparinux should be used cautiously and only in patients who reflect the population of the clinical trials in which the drug was evaluated.

Reference intervals of citrated-native whole blood thromboelastography in premature neonates.

PubMed

Motta, Mario; Guaragni, Brunetta; Pezzotti, Elena; Rodriguez-Perez, Carmen; Chirico, Gaetano

2017-12-01

Bleeding due to acquired coagulation disorders is a common complication in premature neonates. In this clinical setting, standard coagulation laboratory tests might be unsuitable to investigate the hemostatic function as they reflect the concentration of pro-coagulant proteins but not of anti-coagulant proteins. Thromboelastography (TEG), providing a more complete assessment of hemostasis, may be able to overcome some of these limitations. Unfortunately, experience on the use of TEG in premature neonates is very limited and, in particular in this population, reference ranges of TEG parameters have not been yet evaluated. To evaluate TEG in preterm neonates, and to assess their reference ranges. One hundred and eighteen preterm neonates were analyzed for TEG in a retrospective cohort study. Double-sided 95% reference intervals were calculated using a bootstrap method after Box-Cox transformation. TEG parameters were compared between early-preterm and moderate-/late-preterm neonates and between bleeding and non-bleeding preterm neonates. Comparing early-preterm with moderate-/late-preterm neonates, TEG parameters were not statistically different, except for fibrinolysis which was significantly higher in early preterm neonates. Platelet count significantly correlated with α angle and MA parameters. Bleeding and non-bleeding neonates had similar TEG values. These results reinforce the concept that in stable preterm neonates, in spite of lower concentration of pro- and anti-coagulants proteins, the hemostasis is normally balanced and well functioning. Copyright © 2017 Elsevier B.V. All rights reserved.

The role of oral anticoagulants in epistaxis.

PubMed

Buchberger, A M S; Baumann, A; Johnson, F; Peters, N; Piontek, G; Storck, K; Pickhard, A

2018-06-23

The purpose of this retrospective study was to identify the impact of oral anticoagulants on epistaxis with the focus on new oral anticoagulants. The study was conducted at the Department  for Ear- Nose- and Throat (ENT), Head and Neck Surgery, Technical University Munich, Germany. All patients presenting in 2014 with the diagnosis of epistaxis to a specialized ENT accident and emergency department were identified and analyzed in clinical data and medication. 600 adult cases, with a median age of 66.6 years were identified with active bleeding. 66.8% of all cases were anticoagulated. Classic oral anticoagulants (COAC) were three times more common in patients than new-generation oral anticoagulants (NOAC). Recurrent bleeding was significantly associated with oral anticoagulants (OAC) (p = 0.014) and bleeding location was most often anterior (p = 0.006). In contrast, severe cases, which required surgery or embolization were significantly more likely in non-anticoagulated middle-aged patients with posterior bleedings (p < 0.05). In our epistaxis cohort, OAC were highly overrepresented (40%) when compared to the general German population (1%) but COAC as well as NOAC played only a minor role in severe courses of epistaxis. Oral anticoagulation, especially with new-generation drugs, is not associated with more complicated and severe courses of epistaxis, but rather with recurrent bleeding. One should keep this information in mind when triaging the patient in the emergency room and when planning further procedures.

Safety and clinical efficacy of Onyx for embolization of extracranial head and neck vascular anomalies.

PubMed

Thiex, R; Wu, I; Mulliken, J B; Greene, A K; Rahbar, R; Orbach, D B

2011-01-01

Onyx was developed for embolization of central nervous system AVMs but is increasingly used extracranially because of its unique physical properties. We review our experience and results with the use of Onyx for the treatment of fast-flow extracranial vascular lesions. We retrospectively analyzed clinical and imaging records of 22 patients who underwent 71 extracranial embolizations from March 2007 through January 2010. The diagnoses were the following: cervicofacial AVM (n = 18), traumatic fistula (n = 3), and vessel laceration (n = 1). In 62 of 71 procedures (87%), Onyx was the sole embolic agent; it was delivered transarterially in 67/71 and percutaneously in 4/71 procedures. Clinical goals included amelioration of pain and control of bleeding. The clinical efficacy of embolization was judged by symptom control, and adverse events were assessed by clinical examination and history, both postembolization and 4 weeks postprocedure. Cessation of acute bleeding was achieved in 13/14 cases, with 1 case of immediate recurrent massive epistaxis prompting reintubation and further embolization. Control of subacute bleeding episodes and pain was achieved for all patients. Following staged embolization, 7 patients underwent surgical resection without significant blood loss. Surgeons reported high satisfaction with the intraoperative handling properties of Onyx. Transient swelling, local tenderness, or numbness was encountered after 7 procedures. There were no stuck catheters, vessel dissections, or vessel ruptures and no skin discoloration. Staged Onyx embolization was clinically efficacious in managing extracranial fast-flow vascular malformations and lesions, with low associated morbidity.

Major Bleeding Risk During Anticoagulation with Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients with Nonvalvular Atrial Fibrillation.

PubMed

Adeboyeje, Gboyega; Sylwestrzak, Gosia; Barron, John J; White, Jeff; Rosenberg, Alan; Abarca, Jacob; Crawford, Geoffrey; Redberg, Rita

2017-09-01

The use of non-vitamin K oral anticoagulants (NOACs) has increased steadily following marketing approval; however, their relative safety in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice remains unclear. To compare the risk of major bleeding during anticoagulation therapy between warfarin and NOACs. This retrospective cohort study analyzed administrative claims data on new NVAF users of warfarin, dabigatran, apixaban, or rivaroxaban in routine clinical care from November 2010 to February 2015 in a commercially insured population in the United States. The primary outcome was time to first major bleeding event requiring hospitalization. Patients were followed until discontinuation or switch of anticoagulants, health plan disenrollment, death, or end of study. All patient characteristics were balanced after propensity score inverse probability of treatment (IPT) weighting. Event rates by type of anticoagulant exposure were compared using IPT-weighted Cox proportional hazards models. The study cohort comprised 44,057 patients who used warfarin (n = 23,431), dabigatran (n = 8,539), apixaban (n = 3,689), and rivaroxaban (n = 8,398). Overall mean (SD) age was 70 (12) years, and 41% of the patients were women. A total of 2,337 major bleeding events occurred during 36,636.2 person-years of follow-up. The unadjusted rate of major bleeding with warfarin was 6.0 per 100 person-years versus 2.8 with dabigatran, 3.3 with apixban, and 5.0 with rivaroxaban. Relative to warfarin, major bleeding risk was lower with dabigatran (HR = 0.67, 95% CI = 0.60-0.76) and apixaban (HR = 0.52, 95% CI = 0.41-0.67). Compared with rivaroxaban, major bleeding risk was also lower with dabigatran (HR = 0.67, 95% CI = 0.58-0.78) and apixaban (HR = 0.52, 95% CI = 0.40-0.68). Major bleeding risk was similar for rivaroxaban and warfarin. Relative to apixaban, dabigatran was associated with a significantly higher risk of major gastrointestinal bleeding (HR = 1.43, 95% CI = 1.09-1.88). Study results were consistent with safety findings from pivotal clinical trials comparing NOACs with warfarin and added the perspective of a large real-world observational study that compared bleeding risks associated with NOACs during anticoagulation therapy. Apixaban and dabigatran were associated with lower major bleeding risk compared with warfarin or rivaroxaban; however, apixaban had a lower risk of major gastrointestinal bleeding than dabigatran. These findings can help inform the choice of an optimal agent, which must balance effectiveness and bleeding risk in complex patients. This study was funded by Anthem. Adeboyeje, Sylwestrzak, and Barron are employees of HealthCore, a wholly owned and independently operated subsidiary of Anthem. White, Rosenberg, Abarca, and Crawford are employees of Anthem. Study concept and design were primarily contributed by Adeboyeje and Sylwestrzak, along with the other authors. Adeboyeje took the lead in data collection, along with Sylwestrzak and Barron. Data interpretation was performed primarily by Rosenberg, Crawford, and Redberg, with assistance from the other authors. The manuscript was written by all the authors and revised primarily by White, Abarca, and Redberg, along with the other authors.

Transcatheter arterial embolization for traumatic mesenteric bleeding: a 15-year, single-center experience

PubMed Central

Shin, Jong Soo; Shin, Ji Hoon; Ko, Heung-Kyu; Kim, Jong Woo; Yoon, Hyun-Ki

2016-01-01

PURPOSE We aimed to assess the safety and effectiveness of transcatheter arterial embolization (TAE) for mesenteric bleeding following trauma. METHODS From 2001 to 2015, 12 patients were referred to our interventional unit for mesenteric bleeding following trauma, based on clinical decisions and computed tomography (CT) images. After excluding one patient with no bleeding focus and one patient who underwent emergency surgery, a total of 10 patients (male:female ratio, 9:1; mean age, 52.1 years) who underwent super selective TAE of visceral arteries were included in this study. Technical and clinical success, complications, and 30-day mortality rate were analyzed. RESULTS In 10 patients who underwent TAE, the types of trauma were motor vehicle collision (n=6), fall (n=2), assault (n=1), and penetrating injury (n=1), and the bleeding arteries were in the pancreaticoduodenal arterial arcade (n=4), jejunal artery (n=3), colic artery (n=2), and sigmoid artery (n=1). N-butyl-2-cyanoacrylate (NBCA) (n=2), microcoils (n=2), and combinations of NBCA, microcoils, or gelatin sponge particles (n=6) were used as embolic agents. Technical success was achieved in all 10 patients, with immediate cessation of bleeding. Clinical success rate was 90% (9/10), and all patients were discharged with no further treatment required for mesenteric bleeding. However, one patient showed rebleeding 10 days later and underwent repeated TAE with successful result. There were no TAE-related ischemic complications such as bowel infarction. The 30-day mortality rate was 0%. CONCLUSION Our clinical experience suggests that TAE used to control mesenteric bleeding following trauma is safe and effective as a minimally invasive alternative to surgery. PMID:27306658

A study of clinical and endoscopic profile of acute upper, gastrointestinal bleeding.

PubMed

Dewan, K R; Patowary, B S; Bhattarai, S

2014-01-01

Acute Upper Gastrointestinal Bleeding is a common medical emergency with a hospital mortality of approximately 10 percent. Higher mortality rate is associated with rebleeding. Rockall scoring system identifies patients at higher risk of rebleed and mortality. To study the clinical and endoscopic profile of acute upper gastrointestinal bleed to know the etiology, clinical presentation, severity of bleeding and outcome. This is a prospective, descriptive hospital based study conducted in Gastroenterology unit of College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal from January 2012 to January 2013. It included 120 patients at random presenting with manifestations of upper gastrointestinal bleed. Their clinical and endoscopic profiles were studied. Rockall scoring system was used to assess their prognosis. Males were predominant (75%). Age ranged from 14 to 88 years, mean being 48.76+17.19. At presentation 86 patients (71.7%) had both hematemesis and malena, 24 patients (20%) had only malena and 10 patients (8.3%) had only hematemesis. Shock was detected in 21.7%, severe anemia and high blood urea were found in 34.2% and 38.3% respectively. Upper Gastrointestinal Bleeding endoscopy revealed esophageal varices (47.5%), peptic ulcer disease (33.3%), erosive mucosal disease (11.6%), Mallory Weiss tear (4.1%) and malignancy (3.3%). Median hospital stay was 7.28+3.18 days. Comorbidities were present in 43.3%. Eighty six patients (71.7%) had Rockall score < 5 and 34 (28.3%) had >6. Five patients (4.2%) expired. Risk factors for death being massive rebleeeding, comorbidities and Rockall score >6. Acute Upper Gastrointestinal bleeding is a medical emergency. Mortality is associated with massive bleeding, comorbidities and Rockall score >6. Urgent, appropriate hospital management definitely helps to reduce morbidity and mortality.

[Menstrual cycle perception and psychological distress in a sample of Mexican women].

PubMed

Morales-Carmona, Francisco; Pimentel-Nieto, Diana; Bustos-López, Hugo

2008-01-01

To evaluate the association between psychological distress and menstrual bleeding perception, in order to design a psychological intervention for women in reproductive age. Ex post facto and retrospective study in a random sample of women living in Mexico City with ages between 15 to 35 years. The following instruments were administered after reading the informed consent form: demographic and social questionnaire, gyneco-obstetric clinical history, menstrual bleeding diagnostic scale, menstrual bleeding analogical scale and the Goldberg's General Health Questionnaire. 909 women were interviewed and 776 completed the study. A significant statistic association existed between the presence of menorrhagia and the symptoms of psychological distress. Our results suggest a temporary interaction between physiological and psychological symptoms that produce an intense sense of distress in the women.

A prospective randomised comparative study of endoscopic band ligation versus injection sclerotherapy of bleeding internal haemorrhoids in patients with liver cirrhosis.

PubMed

Awad, Atif ElSayed; Soliman, Hanan Hamed; Saif, Sabry Abdel Latif Abou; Darwish, Abdel Monem Nooman; Mosaad, Samah; Elfert, Asem Ahmed

2012-06-01

Bleeding internal haemorrhoids are common and used to be treated surgically with too many complications. Endoscopic therapy is trying to take the lead. Sclerotherapy and rubber band ligation are the candidates to replace surgical therapy especially in patients with liver cirrhosis. The aim of this study was to compare endoscopic injection sclerotherapy (EIS) to endoscopic rubber band ligation (EBL) regarding effectiveness and complications in the treatment of bleeding internal haemorrhoids in Egyptian patients with liver cirrhosis. One hundred and twenty adult patients with liver cirrhosis and bleeding internal haemorrhoids were randomised into two equal groups; the first treated with EBL using Saeed multiband ligator, and the second with EIS using either ethanolamine oleate 5% or N-butyl cyanoacrylate. All groups were matched as regards age, sex, Child score and pre-procedure Doppler values. Patients were followed up clinically and with abdominal ultrasound/Doppler for 6 months. Endoscopic and endosonography/Doppler was done before and one month after the procedure. Pre and post-procedure data were recorded and analysed. Both techniques were highly effective in the control of bleeding from internal haemorrhoids with a low rebleeding [10% in the EBL group and 13.33% in the EIS group] and recurrence [20% in the EBL group 20% in the EIS group] rates. Child score had a positive correlation with rebleeding and recurrence in EIS group only. Pain score and need for analgesia were significantly higher while patient satisfaction was significantly lower in EIS compared to EBL [p<0.05]. No significant difference between ethanolamine and cyanoacrylate subgroups was found [p>0.05]. Both EBL and EIS were effective in the treatment of bleeding internal haemorrhoids in patients with liver cirrhosis. EBL had significantly less pain and higher patient satisfaction than EIS. EBL was also safer in patients with advanced cirrhosis. Copyright © 2012 Arab Journal of Gastroenterology. Published by Elsevier Ltd. All rights reserved.

Dental postoperative bleeding complications in patients with suspected and documented liver disease.

PubMed

Hong, C H; Scobey, M W; Napenas, J J; Brennan, M T; Lockhart, P B

2012-10-01

The aims of this study were to determine the frequency of bleeding complications following dental procedures in patients with known or suspected chronic liver disease and whether international normalized ratio (INR) determination could aid in predicting bleeding complications in these patients. We identified 90 patients (mean age: 51 ± 9 years) in this retrospective chart review. Sixty-nine patients had a known history of chronic liver disease and 21 had suspected chronic liver disease. Descriptive statistics were determined. Independent sample t-test and one-way variance test were utilized for continuous variables and chi-square test for dichotomous variables. The mean INR value for all patients was 1.2 ± 0.3. The INR value was significantly associated with the diagnosis of liver cirrhosis, the diagnoses of Hepatitis B and C together, the presence of ascites alone, and the number of clinical signs and symptoms (i.e. ascites, jaundice and encephalopathy) present. Nine patients with INR values between 1.5 and 2 underwent invasive dental procedures without postoperative bleeding complications. There were no episodes of postoperative bleeding in patients. The findings suggest that clinicians should not rely solely on an INR value to predict post-procedure bleeding in patients with liver disease. © 2012 John Wiley & Sons A/S.

What Impact Does Venous Thromboembolism and Bleeding Have on Cancer Patients' Quality of Life?

PubMed

Lloyd, Andrew J; Dewilde, Sarah; Noble, Simon; Reimer, Elisabeth; Lee, Agnes Y Y

2018-04-01

Venous thromboembolism (VTE) is common in cancer patients and its treatment is associated with a high risk of recurrent VTE (rVTE) and bleeding. To analyze data from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) trial to describe the impact of rVTE and bleeding events on health-related quality of life. The three-level EuroQol five-dimensional questionnaire (EQ-5D) data were collected monthly for up to 7 months in patients starting anticoagulation for newly diagnosed VTE. Analyses were designed to describe the impact of rVTE and bleeding on EQ-5D scores while controlling for effects of covariates such as background and clinical variables and longitudinal changes. A repeated-measures model with specification of the variance-covariance matrix to characterize the intrapatient correlation was used to estimate the utility values. The impact of an rVTE or a bleeding event was assumed to be reflected in the utility value when it occurred within 2 weeks from a planned data collection point. Data were available from 883 patients. A total of 76 rVTE and 159 bleeding events occurred during follow-up. rVTE had a significant impact on EQ-5D scores, with a decrement of -0.075 on the basis of our reference case (male, no metastasis, Eastern Cooperative Oncology Group score = 1, Western European), but different patients might have different decrements. Bleeding events had a smaller (nonstatistically significant) impact on EQ-5D scores. This data set study has quantified the decline in EQ-5D scores associated with experiencing rVTE or bleeding events in cancer patients. These results indicate the net gain in quality of life and impact on cost-effectiveness of secondary VTE prevention. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Internal sphincter and the nature of haemorrhoids.

PubMed Central

Hancock, B D

1977-01-01

Internal anal sphincter activity has been studied in 84 patients with haemorrhoids and 40 asymptomatic subjects. Activity was estimated by measuring maximum resting anal pressure with a water filled anal balloon probe 7 mm in diameter connected to a strain gauge pressure transducer. There was greater activity of the internal sphincter in patients with haemorrhoids than in controls, but there was no significant relationship between sphincter activity and duration of symptoms, predominant symptom (bleeding or prolapse), severity of symptoms, history of pain, history of straining at stool, or size of haemorrhoids. Straining at stool occurred significantly more often in patients whose main complaint was prolapse than in those whose main complaint was bleeding. Anal dilatation reduced sphincter activity and the best clinical results were obtained in those with the most active sphincter. An internal sphincter abnormality may be an aetiological factor in some patients but there must be other factors as well. Straining at stool may determine whether bleeding or prolapse is the predominant symptom. Images Fig. 1 PMID:892612

Major bleeding risks of different low-molecular-weight heparin agents: a cohort study in 12 934 patients treated for acute venous thrombosis.

PubMed

van Rein, N; Biedermann, J S; van der Meer, F J M; Cannegieter, S C; Wiersma, N; Vermaas, H W; Reitsma, P H; Kruip, M J H A; Lijfering, W M

2017-07-01

Essentials Low-molecular-weight-heparins (LMWH) kinetics differ which may result in different bleeding risks. A cohort of 12 934 venous thrombosis patients on LMWH was followed until major bleeding. The absolute major bleeding risk was low among patients registered at the anticoagulation clinic. Once-daily dosing was associated with a lower bleeding risk as compared with twice-daily. Background Low-molecular-weight heparins (LMWHs) are considered members of a class of drugs with similar anticoagulant properties. However, pharmacodynamics and pharmacokinetics between LMWHs differ, which may result in different bleeding risks. As these agents are used by many patients, small differences may lead to a large effect on numbers of major bleeding events. Objectives To determine major bleeding risks for different LMWH agents and dosing schedules. Methods A cohort of acute venous thrombosis patients from four anticoagulation clinics who used an LMWH and a vitamin K antagonist were followed until they ceased LMWH treatment or until major bleeding. Exposures were classified according to different types of LMWHs and for b.i.d. and o.d. use. Cumulative incidences for major bleeding per 1000 patients and risk ratios were calculated and adjusted for study center. Results The study comprised 12 934 patients with a mean age of 59 years; 6218 (48%) were men. The cumulative incidence of major bleeding was 2.5 per 1000 patients (95% confidence interval [CI], 1.7-3.5). Enoxaparin b.i.d. or o.d. was associated with a relative bleeding risk of 1.7 (95% CI, 0.2-17.5) compared with nadroparin o.d. In addition, a nadroparin b.i.d. dosing schedule was associated with a 2.0-fold increased major bleeding risk (95% CI, 0.8-5.1) as compared with a nadroparin o.d. dosing schedule. Conclusions Absolute major bleeding rates were low for all LMWH agents and dosing schedules in a large unselected cohort. Nevertheless, twice-daily dosing with nadroparin appeared to be associated with an increased major bleeding risk as compared with once-daily dosing, as also suggested in a meta-analysis of controlled clinical trials. © 2017 International Society on Thrombosis and Haemostasis.

Plug-Assisted Retrograde Transvenous Obliteration for the Treatment of Gastric Variceal Hemorrhage

PubMed Central

Chang, Min-Yung; Kim, Taehwan; Shin, Wonseon; Shin, Minwoo; Kim, Gyoung Min; Won, Jong Yun; Park, Sung Il; Lee, Do Yun

2016-01-01

Objective To evaluate the feasibility, safety, and clinical outcomes of plug-assisted retrograde transvenous obliteration (PARTO) to treat gastric variceal hemorrhage in patients with portal hypertension. Materials and Methods From May 2012 to June 2014, 19 patients (11 men and 8 women, median age; 61, with history of gastric variceal hemorrhage; 17, active bleeding; 2) who underwent PARTO using a vascular plug and a gelfoam pledget were retrospectively analyzed. Clinical and laboratory data were examined to evaluate primary (technical and clinical success, complications) and secondary (worsening of esophageal varix [EV], change in liver function) end points. Median follow-up duration was 11 months, from 6.5 to 18 months. The Wilcoxon signed-rank test was used to compare laboratory data before and after the procedure. Results Technical success (complete occlusion of the efferent shunt and complete filling of gastric varix [GV] with a gelfoam slurry) was achieved in 18 of 19 (94.7%) patients. The embolic materials could not reach the GV in 1 patient who had endoscopic glue injection before our procedure. The clinical success rate (no recurrence of gastric variceal bleeding) was the same because the technically failed patient showed recurrent bleeding later. Acute complications included fever (n = 2), fever and hypotension (n = 2; one diagnosed adrenal insufficiency), and transient microscopic hematuria (n = 3). Ten patients underwent follow-up endoscopy; all exhibited GV improvement, except 2 without endoscopic change. Five patients exhibited aggravated EV, and 2 of them had a bleeding event. Laboratory findings were significantly improved after PARTO. Conclusion PARTO is technically feasible, safe, and effective for gastric variceal hemorrhage in patients with portal hypertension. PMID:26957908

Dose of Prophylactic Platelet Transfusions and Prevention of Hemorrhage

PubMed Central

Slichter, Sherrill J.; Kaufman, Richard M.; Assmann, Susan F.; McCullough, Jeffrey; Triulzi, Darrell J.; Strauss, Ronald G.; Gernsheimer, Terry B.; Ness, Paul M.; Brecher, Mark E.; Josephson, Cassandra D.; Konkle, Barbara A.; Woodson, Robert D.; Ortel, Thomas L.; Hillyer, Christopher D.; Skerrett, Donna L.; McCrae, Keith R.; Sloan, Steven R.; Uhl, Lynne; George, James N.; Aquino, Victor M.; Manno, Catherine S.; McFarland, Janice G.; Hess, John R.; Leissinger, Cindy; Granger, Suzanne

2010-01-01

BACKGROUND We conducted a trial of prophylactic platelet transfusions to evaluate the effect of platelet dose on bleeding in patients with hypoproliferative thrombocytopenia. METHODS We randomly assigned hospitalized patients undergoing hematopoietic stem-cell transplantation or chemotherapy for hematologic cancers or solid tumors to receive prophylactic platelet transfusions at a low dose, a medium dose, or a high dose (1.1×1011, 2.2×1011, or 4.4×1011 platelets per square meter of body-surface area, respectively), when morning platelet counts were 10,000 per cubic millimeter or lower. Clinical signs of bleeding were assessed daily. The primary end point was bleeding of grade 2 or higher (as defined on the basis of World Health Organization criteria). RESULTS In the 1272 patients who received at least one platelet transfusion, the primary end point was observed in 71%, 69%, and 70% of the patients in the low-dose group, the medium-dose group, and the high-dose group, respectively (differences were not significant). The incidences of higher grades of bleeding, and other adverse events, were similar among the three groups. The median number of platelets transfused was significantly lower in the low-dose group (9.25×1011) than in the medium-dose group (11.25×1011) or the high-dose group (19.63×1011) (P = 0.002 for low vs. medium, P<0.001 for high vs. low and high vs. medium), but the median number of platelet transfusions given was significantly higher in the low-dose group (five, vs. three in the medium-dose and three in the high-dose group; P<0.001 for low vs. medium and low vs. high). Bleeding occurred on 25% of the study days on which morning platelet counts were 5000 per cubic millimeter or lower, as compared with 17% of study days on which platelet counts were 6000 to 80,000 per cubic millimeter (P<0.001). CONCLUSIONS Low doses of platelets administered as a prophylactic transfusion led to a decreased number of platelets transfused per patient but an increased number of transfusions given. At doses between 1.1×1011 and 4.4×1011 platelets per square meter, the number of platelets in the prophylactic transfusion had no effect on the incidence of bleeding. (ClinicalTrials.gov number, NCT00128713.) PMID:20164484

Increasing numbers of nonaneurysmal subarachnoid hemorrhage in the last 15 years: antithrombotic medication as reason and prognostic factor?

PubMed

Konczalla, Juergen; Kashefiolasl, Sepide; Brawanski, Nina; Senft, Christian; Seifert, Volker; Platz, Johannes

2016-06-01

OBJECT Subarachnoid hemorrhage (SAH) is usually caused by a ruptured intracranial aneurysm, but in some patients no source of hemorrhage can be detected. More recent data showed increasing numbers of cases of spontaneous nonaneurysmal SAH (NASAH). The aim of this study was to analyze factors, especially the use of antithrombotic medications such as systemic anticoagulation or antiplatelet agents (aCPs), influencing the increasing numbers of cases of NASAH and the clinical outcome. METHODS Between 1999 and 2013, 214 patients who were admitted to the authors' institution suffered from NASAH, 14% of all patients with SAH. Outcome was assessed according to the modified Rankin Scale (mRS) at 6 months. Risk factors were identified based on the outcome. RESULTS The number of patients with NASAH increased significantly in the last 15 years of the study period. There was a statistically significant increase in the rate of nonperimesencephalic (NPM)-SAH occurrence and aCP use, while the proportion of elderly patients remained stable. Favorable outcome (mRS 0-2) was achieved in 85% of cases, but patients treated with aCPs had a significantly higher risk for an unfavorable outcome. Further analysis showed that elderly patients, and especially the subgroup with a Fisher Grade 3 bleeding pattern, had a high risk for an unfavorable outcome, whereas the subgroup of NPM-SAH without a Fisher Grade 3 bleeding pattern had a favorable outcome, similar to perimesencephalic (PM)-SAH. CONCLUSIONS Over the years, a significant increase in the number of patients with NASAH has been observed. Also, the rate of aCP use has increased significantly. Risk factors for an unfavorable outcome were age > 65 years, Fisher Grade 3 bleeding pattern, and aCP use. Both "PM-SAH" and "NPM-SAH without a Fisher Grade 3 bleeding pattern" had excellent outcomes. Patients with NASAH and a Fisher Grade 3 bleeding pattern had a significantly higher risk for an unfavorable outcome and death. Therefore, for further investigations, NPM-SAH should be stratified into patients with or without a Fisher Grade 3 bleeding pattern. Also, cases of spontaneous SAH should be stratified into NASAH and aneurysmal SAH.

Vascular Plug Assisted Retrograde Transvenous Obliteration (PARTO) for Gastric Varix Bleeding Patients in the Emergent Clinical Setting

PubMed Central

Yang, Heechul; Lee, Chun Kyon; Kim, Gun Bea

2016-01-01

Purpose To evaluate the technical feasibility and safety of vascular plug assisted retrograde transvenous obliteration (PARTO) for bleeding gastric varix performed in the emergent clinical setting and describe the mid-term clinical results. Materials and Methods From April 2012 to January 2015, emergent PARTO was tried in total 9 patients presented with active gastric varix bleeding. After initial insufficient or failure of endoscopic approach, they underwent PARTO in the emergent clinical setting. Gelatin sponge embolization of both gastrorenal (GR) shunt and gastric varix was performed after retrograde transvenous placement of a vascular plug in GR shunt. Coil assisted RTO (CARTO) was performed in one patient who had challenging GR shunt anatomy for vascular plug placement. Additional embolic materials, such as microcoils and NBCA glue-lipiodol mixture, were required in three patients to enhance complete occlusion of GR shunt or obliteration of competitive collateral vessels. Clinical success was defined as no variceal rebleeding and disappearance of gastric varix. Results All technical and clinical success–i.e., complete GR shunt occlusion and offending gastric varix embolization with immediate bleeding control–was achieved in all 9 patients. There was no procedure-related complication. All cases showed successful clinical outcome during mean follow up of 17 months (12–32 months), evidenced by imaging studies, endoscopy and clinical data. In 4 patients, mild worsening of esophageal varices or transient ascites was noted as portal hypertensive related change. Conclusion Emergent PARTO is technically feasible and safe, with acceptable mid-term clinical results, in treating active gastric varix bleeding. PMID:27189294

Guidelines for endoscopic management of non-variceal upper gastrointestinal bleeding.

PubMed

Fujishiro, Mitsuhiro; Iguchi, Mikitaka; Kakushima, Naomi; Kato, Motohiko; Sakata, Yasuhisa; Hoteya, Shu; Kataoka, Mikinori; Shimaoka, Shunji; Yahagi, Naohisa; Fujimoto, Kazuma

2016-05-01

Japan Gastroenterological Endoscopy Society (JGES) has compiled a set of guidelines for endoscopic management of non-variceal upper gastrointestinal bleeding using evidence-based methods. The major cause of non-variceal upper gastrointestinal bleeding is peptic gastroduodenal ulcer bleeding. As a result, these guidelines mainly focus on peptic gastroduodenal ulcer bleeding, although bleeding from other causes is also overviewed. From the epidemiological aspect, in recent years in Japan, bleeding from drug-related ulcers has become predominant in comparison with bleeding from Helicobacter pylori (HP)-related ulcers, owing to an increase in the aging population and coverage of HP eradication therapy by national health insurance. As for treatment, endoscopic hemostasis, in which there are a variety of methods, is considered to be the first-line treatment for bleeding from almost all causes. It is very important to precisely evaluate the severity of the patient's condition and stabilize the patient's vital signs with intensive care for successful endoscopic hemostasis. Additionally, use of antisecretory agents is recommended to prevent rebleeding after endoscopic hemostasis, especially for gastroduodenal ulcer bleeding. Eighteen statements with evidence and recommendation levels have been made by the JGES committee of these guidelines according to evidence obtained from clinical research studies. However, some of the statements that are supported by a low level of evidence must be confirmed by further clinical research. © 2016 Japan Gastroenterological Endoscopy Society.

Upper gastrointestinal bleeding in severely burned patients: a case-control study to assess risk factors, causes, and outcome.

PubMed

Kim, Young Jin; Koh, Dong Hee; Park, Se Woo; Park, Sun Man; Choi, Min Ho; Jang, Hyun Joo; Kae, Sea Hyub; Lee, Jin; Byun, Hyun Woo

2014-01-01

To determine the risk factors, causes, and outcome of clinically important upper gastrointestinal bleeding that occurs in severely burned patients. The charts of all patients admitted to the burn intensive care unit were analyzed retrospectively over a 4-year period (from January 2006 to December 2009). Cases consisted of burned patients who developed upper gastrointestinal bleeding more than 24 hours after admission to the burn intensive care unit. Controls were a set of patients, in the burn intensive care unit, without upper gastrointestinal bleeding matched with cases for age and gender. Cases and controls were compared with respect to the risk factors of upper gastrointestinal bleeding and outcomes. During the study period, clinically important upper gastrointestinal bleeding occurred in 20 patients out of all 964 patients. The most common cause of upper gastrointestinal bleeding was duodenal ulcer (11 of 20 cases, 55%). In the multivariate analysis, mechanical ventilation (p = 0.044) and coagulopathy (p = 0.035) were found to be the independent predictors of upper gastrointestinal bleeding in severely burned patients. Upper gastrointestinal hemorrhage tends to occur more frequently after having prolonged mechanical ventilation and coagulopathy.

Analysis of risk factor and clinical characteristics of angiodysplasia presenting as upper gastrointestinal bleeding.

PubMed

Kim, Dae Bum; Chung, Woo Chul; Lee, Seok Jong; Sung, Hea Jung; Woo, Seokyung; Kim, Hyo Suk; Jeong, Yeon Oh; Lee, Hyewon; Kim, Yeon-Ji

2016-07-01

Angiodysplasia is important in the differential diagnosis of upper gastrointestinal bleeding (UGIB), but the clinical features and outcomes associated with UGIB from angiodysplasia have not been characterized. We aimed to analyze the clinical characteristics and outcomes of angiodysplasia presented as UGIB. Between January 2004 and December 2013, a consecutive series of patients admitted with UGIB were retrospectively analyzed. Thirty-five patients with bleeding from angiodysplasia were enrolled. We compared them with an asymptomatic control group (incidental finding of angiodysplasia in health screening, n = 58) and bleeding control group (simultaneous finding of angiodysplasia and peptic ulcer bleeding, n = 28). When patients with UGIB from angiodysplasia were compared with the asymptomatic control group, more frequent rates of nonantral location and large sized lesion (≥ 1 cm) were evident in multivariate analysis. When these patients were compared with the bleeding control group, they were older (mean age: 67.94 ± 9.16 years vs.55.07 ± 13.29 years, p = 0.03) and received less transfusions (p = 0.03). They also had more frequent rate of recurrence (40.0% vs. 20.7%, p = 0.02). Non-antral location and large lesions (≥ 1 cm) could be risk factors of UGIB of angiodysplasia. UGIB due to angiodysplasia was more common in older patients. Transfusion requirement would be less and a tendency of clinical recurrence might be apparent.

Efficacy and Safety of Rivaroxaban Versus Warfarin in Patients Taking Nondihydropyridine Calcium Channel Blockers for Atrial Fibrillation (from the ROCKET AF Trial).

PubMed

Washam, Jeffrey B; Hellkamp, Anne S; Lokhnygina, Yuliya; Piccini, Jonathan P; Berkowitz, Scott D; Nessel, Christopher C; Becker, Richard C; Breithardt, Günter; Fox, Keith A A; Halperin, Jonathan L; Hankey, Graeme J; Mahaffey, Kenneth W; Singer, Daniel E; Patel, Manesh R

2017-08-15

Non-dihydropyridine calcium channel blockers (non-DHP CCBs) possess combined P-glycoprotein and moderate CYP3A4 inhibition, which may lead to increased exposure of medications that are substrates for these metabolic pathways, such as rivaroxaban. We evaluated the use and outcomes of non-DHP CCBs in patients with atrial fibrillation (AF) in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). We assessed clinical outcomes in patients who received non-DHP CCBs and the impact on the efficacy and safety of rivaroxaban compared with warfarin. Stroke or noncentral nervous system (CNS) systemic embolism (SE), major or nonmajor clinically relevant (NMCR) bleeding, all-cause death, and major bleeding were compared according to non-DHP CCB use. At randomization, 1,308 patients (9.2%) were taking a non-DHP CCB. They were more likely to be women, have diabetes and COPD, and less likely to have heart failure and had a lower mean CHADS 2 score (3.3 vs 3.5). Non-DHP CCB use was not associated with an increased risk of stroke/non-CNS SE (p = 0.11) or the composite outcome of NMCR or major bleeding (p = 0.087). Non-DHP CCB use was associated with an increased risk of major bleeding (adjusted hazard ratio 1.50, 95% CI 1.11 to 2.04) and intracranial hemorrhage (adjusted hazard ratio 2.84, 95% CI 1.53 to 5.29). No significant difference was observed in the primary efficacy (stroke or non-CNS SE; adjusted interaction p value = 0.38) or safety outcome (NMCR or major bleeding; adjusted interaction p value = 0.14) between rivaroxaban and warfarin with non-DHP CCB use. In conclusion, although the overall use of non-DHP CCBs was associated with an increased risk of major bleeding and intracranial hemorrhage, the use was not associated with a significant change in the safety or efficacy of rivaroxaban compared with warfarin observed in ROCKET AF. Copyright © 2017 Elsevier Inc. All rights reserved.

[Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?].

PubMed

Lee, Su Hyun; Jung, Jin Tae; Lee, Dong Wook; Ha, Chang Yoon; Park, Kyung Sik; Lee, Si Hyung; Yang, Chang Heon; Park, Youn Sun; Jeon, Seong Woo

2015-08-01

Endoscopic hemoclip application is an effective and safe method of endoscopic hemostasis. We conducted a multicenter retrospective study on hemoclip and hemoclip combination therapy based on prospective cohort database in terms of hemostatic efficacy not in clinical trial but in real clinical practice. Data on endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB) were prospectively collected from February 2011 to December 2013. Among 1,584 patients with NVUGIB, 186 patients treated with hemoclip were enrolled in this study. Subjects were divided into three groups: Group 1 (n = 62), hemoclipping only; group 2 (n = 88), hemoclipping plus epinephrine injection; and group 3 (n = 36), hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. Primary outcomes included rebleeding, other therapeutic management, hospitalization period, fasting period and mortality. Secondary outcomes were bleeding associated mortality and overall mortality. Active bleeding and peptic ulcer bleeding were more common in group 3 than in group 1 and in group 2 (p <œ 0.001). However, primary outcomes (rebleeding, other management, morbidity, hospitalization period, fasting period and mortality) and secondary outcomes (bleeding associated mortality and total mortality) were not different among groups. Combination therapy of epinephrine injection and other modalities with hemoclips did not show advantage over hemoclipping alone in this prospective cohort study. However, there is a tendency to perform combination therapy in active bleeding which resulted in equivalent hemostatic success rate, and this reflects the role of combination therapy in clinical practice.

Gastrointestinal bleeding and subsequent risk of thromboembolic events during support with a left ventricular assist device.

PubMed

Stulak, John M; Lee, Dustin; Haft, Jonathon W; Romano, Matthew A; Cowger, Jennifer A; Park, Soon J; Aaronson, Keith D; Pagani, Francis D

2014-01-01

Modern left ventricular assist devices (LVAD) require anti-coagulation (AC) with warfarin and anti-platelet therapy to prevent thromboembolic complications in patients. Gastrointestinal bleeding (GI) is a significant adverse event in these patients and treatment typically requires reduction or elimination of AC or anti-platelet therapy. It is not known whether alterations in AC to treat GI bleeding influence subsequent risk of thromboembolic (TE) events during LVAD support. Between July 2003 and September 2011, 389 patients (308 male) underwent implantation of a continuous-flow LVAD at the University of Michigan Health System and the Mayo Clinic. Median age at implant was 60 years (range 18 to 79 years). Outcomes were analyzed for the association of GI bleeding events and subsequent TE events, defined as stroke, transient ischemic attack, hemolysis or suspected or confirmed pump thrombosis. Median survival was 10 months (maximum 7.2 years, total 439 patient-years). TE events occurring within the first 30 days were not counted. Overall survival and freedom from an outcome event were assessed using the Kaplan-Meier method. Associations between GI bleeding and subsequent TE events and survival impact were analyzed as time-dependent covariates. One hundred ninety-nine GI bleeding episodes occurred in 116 of 389 patients (30%) for an event rate of 0.45 GI bleed/patient-year of support. One hundred thirty-eight TE events occurred in 97 of 389 patients (25%) for an event rate of 0.31 TE event/patient-year of support. Median time from LVAD implant to first GI bleed was 5 months (range 1 to 116 months) and to first TE event was 6 months (range 1 to 29 months). For patients who had a TE event after GI bleed, the median interval was 5 months (range 0.5 to 25 months). TE events were 7.4-fold more likely in patients who had a prior GI bleed (range 4.9- to 11.1-fold) (p < 0.001); however, neither the presence of GI bleeding (0.7 to 1.2) nor a TE event (0.8 to 2.0) portended a lower overall survival. Patients who had GI bleeding were at significantly higher risk for a subsequent TE event. Although the exact cause of this relationship is unknown, it suggests that a reduction in anti-coagulation and anti-platelet management to treat GI bleeds may contribute to this risk. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Diagnosis of gastrointestinal bleeding: A practical guide for clinicians

PubMed Central

Kim, Bong Sik Matthew; Li, Bob T; Engel, Alexander; Samra, Jaswinder S; Clarke, Stephen; Norton, Ian D; Li, Angela E

2014-01-01

Gastrointestinal bleeding is a common problem encountered in the emergency department and in the primary care setting. Acute or overt gastrointestinal bleeding is visible in the form of hematemesis, melena or hematochezia. Chronic or occult gastrointestinal bleeding is not apparent to the patient and usually presents as positive fecal occult blood or iron deficiency anemia. Obscure gastrointestinal bleeding is recurrent bleeding when the source remains unidentified after upper endoscopy and colonoscopic evaluation and is usually from the small intestine. Accurate clinical diagnosis is crucial and guides definitive investigations and interventions. This review summarizes the overall diagnostic approach to gastrointestinal bleeding and provides a practical guide for clinicians. PMID:25400991

Risk of bleeding in surgical patients treated with topical bovine thrombin sealants: a review of the literature

PubMed Central

Reynolds, Matthew W; Clark, John; Crean, Sheila; Samudrala, Srinath

2008-01-01

Background One of the most anticipated, but potentially serious complications during or after surgery are bleeding events. Among the many potential factors associated with bleeding complications in surgery, the use of bovine thrombin has been anecdotally identified as a possible cause of increased bleeding risk. Most of these reports of bleeding events in association with the use of topical bovine thrombin have been limited to case reports lacking clear cause and effect relationship determination. Recent studies have failed to establish significant differences in the rates of bleeding events between those treated with bovine thrombin and those treated with either human or recombinant thrombin. Methods We conducted a search of MEDLINE for the most recent past 10 years (1997–2007) and identified all published studies that reported a study of surgical patients with a clear objective to examine the risk of bleeding events in surgical patients. We also specifically noted the reporting of any topical bovine thrombin used during surgical procedures. We aimed to examine whether there were any differences in the risk of bleeds in general surgical populations as compared to those studies that reported exposure to topical bovine thrombin. Results We identified 21 clinical studies that addressed the risk of bleeding in surgery. Of these, 5 studies analyzed the use of bovine thrombin sealants in surgical patients. There were no standardized definitions for bleeding events employed across these studies. The rates of bleeds in the general surgery studies ranged from 0.1%–20.2%, with most studies reporting rates between 2.6%–4%. The rates of bleeding events ranged from 0.0%–13% in the bovine thrombin studies with most studies reporting between a 2%–3% rate. Conclusion The risk of bleeds was not clearly different in those studies reporting use of bovine thrombin in all patients compared to the other surgical populations studied. A well-designed and well-controlled study is needed to accurately examine the bleeding risks in surgical patients treated and unexposed to topical bovine thrombin, and to evaluate the independent risk associated with topical bovine thrombin as well as other risk factors. PMID:18348725

Gastrointestinal bleeding in patients with renal failure under hemodialysis treatment: a single-center experience.

PubMed

Can, Özgür; Koç, Gözde; Ocak, Sema Berk; Akbay, Nursel; Ahishali, Emel; Canbakan, Mustafa; Şahin, Gülizar Manga; Apaydin, Süheyla

2017-05-01

Gastrointestinal bleeding remains the leading cause of morbidity and mortality for patients who need hemodialysis treatment. Our aim was to evaluate patients who needed hemodialysis and presented with bleeding during their hospital stay (uremic bleeding patients). Factors that increased the risk of bleeding and death were evaluated. Additionally, uremic bleeding patients were compared to non-uremic bleeding patients regarding gastrointestinal findings. Fifty-one uremic bleeding patients were compared to two control groups which included uremic (hemodialysis dependent and non-bleeding) and non-uremic (no renal insufficiency and bleeding) patients. NSAIDs and anti-ulcer drug usage were more common in uremic bleeding and in uremic non-bleeding groups, respectively. Dialysis vintage was longer in uremic bleeding group. Comparison of uremic bleeding and non-bleeding uremic patients regarding the usage of ACEI or ARB drugs yielded non-significant results. Acute kidney injury, lower plasma albumin level and high CRP level were significantly increased the risk of mortality in uremic bleeding patients. Hospital stay more than 1 week was the only strong factor for mortality when multivariate analysis was performed. Gastroduodenal and duodenal ulcers were significantly detected in uremic bleeding and non-uremic bleeding patients; respectively. Hemodialysis patients presenting with gastrointestinal bleeding should be evaluated regarding use of prescriptions and efforts should be done in order to shorten their hospital stay and decrease their mortality. Effect of ACEI or ARB drugs should also be evaluated in future studies.

The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial.

PubMed

Brenner, Amy; Shakur-Still, Haleema; Chaudhri, Rizwana; Fawole, Bukola; Arulkumaran, Sabaratnam; Roberts, Ian

2018-06-07

In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19-0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33-1.86). Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after excluding early hysterectomies. ISRCTN trial registration number ISRCTN76912190, 8 Dec 2008; ClinicalTrials.gov number NCT00872469, 30 March 2009; PACTR number PACTR201007000192283, 9 Feb 2010; EudraCT number 2008-008441-38, 8 Dec 2010 (retrospectively registered).

Correlation Between Findings of Multislice Helical Computed Tomography (CT), Endoscopic Examinations, Endovascular Procedures, and Surgery in Patients with Symptoms of Acute Gastrointestinal Bleeding.

PubMed

Konecki, Dariusz; Grabowska-Derlatka, Laretta; Pacho, Ryszard; Rowiński, Olgierd

2017-01-01

Endoscopic methods (gastroscopy and colonoscopy) are considered fundamental for the diagnosis of gastrointestinal bleeding. In recent years, multidetector computed tomography (MDCT) has also gained importance in diagnosing gastrointestinal bleeding, particularly in hemodynamically unstable patients and in cases with suspected lower gastrointestinal tract bleeding. CT can detect both the source and the cause of active gastrointestinal bleeding, thereby expediting treatment initiation. The study group consisted of 16 patients with clinical symptoms of gastrointestinal bleeding in whom features of active bleeding were observed on CT. In all patients, bleeding was verified by means of other methods such as endoscopic examinations, endovascular procedures, or surgery. The bleeding source was identified on CT in all 16 patients. In 14 cases (87.5%), bleeding was confirmed by other methods. CT is an efficient, fast, and readily available tool for detecting the location of acute gastrointestinal bleeding.

ACG Clinical Guideline: Management of Patients With Acute Lower Gastrointestinal Bleeding.

PubMed

Strate, Lisa L; Gralnek, Ian M

2016-04-01

This guideline provides recommendations for the management of patients with acute overt lower gastrointestinal bleeding. Hemodynamic status should be initially assessed with intravascular volume resuscitation started as needed. Risk stratification based on clinical parameters should be performed to help distinguish patients at high- and low-risk of adverse outcomes. Hematochezia associated with hemodynamic instability may be indicative of an upper gastrointestinal (GI) bleeding source and thus warrants an upper endoscopy. In the majority of patients, colonoscopy should be the initial diagnostic procedure and should be performed within 24 h of patient presentation after adequate colon preparation. Endoscopic hemostasis therapy should be provided to patients with high-risk endoscopic stigmata of bleeding including active bleeding, non-bleeding visible vessel, or adherent clot. The endoscopic hemostasis modality used (mechanical, thermal, injection, or combination) is most often guided by the etiology of bleeding, access to the bleeding site, and endoscopist experience with the various hemostasis modalities. Repeat colonoscopy, with endoscopic hemostasis performed if indicated, should be considered for patients with evidence of recurrent bleeding. Radiographic interventions (tagged red blood cell scintigraphy, computed tomographic angiography, and angiography) should be considered in high-risk patients with ongoing bleeding who do not respond adequately to resuscitation and who are unlikely to tolerate bowel preparation and colonoscopy. Strategies to prevent recurrent bleeding should be considered. Nonsteroidal anti-inflammatory drug use should be avoided in patients with a history of acute lower GI bleeding, particularly if secondary to diverticulosis or angioectasia. Patients with established high-risk cardiovascular disease should not stop aspirin therapy (secondary prophylaxis) in the setting of lower GI bleeding. [corrected]. The exact timing depends on the severity of bleeding, perceived adequacy of hemostasis, and the risk of a thromboembolic event. Surgery for the prevention of recurrent lower gastrointestinal bleeding should be individualized, and the source of bleeding should be carefully localized before resection.

Transcatheter Arterial Embolization of Angiographically Visible and Occult Renal Capsular Artery Hemorrhage in 28 Patients.

PubMed

Park, Hyo Jung; Shin, Ji Hoon; Han, Ki-Chang; Yoon, Hyun-Ki; Ko, Gi-Young; Sung, Kyu-Bo

2016-07-01

To evaluate the effectiveness and safety of transcatheter arterial embolization to control bleeding from the renal capsular artery (RCA). Embolization was performed in 28 patients (14 men; mean age, 49.7 y). Presence and type of previous invasive procedures, initial presentation, and coagulation profile were reviewed. Any preceding abdominal computed tomography (CT) findings were analyzed. Angiographic findings were categorized as active bleeding, suspicious for bleeding, or no bleeding. Technical and clinical success and clinical outcomes were evaluated. Changes in hemoglobin level and transfusion volume of packed red blood cells (pBRCs) before and after embolization were evaluated with the paired t test and Wilcoxon signed-rank test, respectively. Technical and clinical success rates of therapeutic embolization for active bleeding (n = 11) were 90.9% and 80%, respectively. One case of technical failure (5.9%) and 3 cases of postembolization bleeding (18.7%) were noted in the prophylactic embolization group in patients with suspicion of bleeding (n = 13) or no bleeding (n = 4). Transient renal insufficiency occurred in 4 patients (14.3%). The average hemoglobin level and volume of transfused pBRCs changed from 8.1 g/dL to 9.9 g/dL and from 871 mL to 543 mL, respectively (P < .05). Extravasation of contrast media or acute hematoma in the right subhepatic or perirenal space on CT was noted in 21 patients (78%). Embolization can provide an effective and safe method to control RCA bleeding. Perirenal invasive procedures and signs of active or recent right subhepatic or perirenal hemorrhage should raise the suspicion of an RCA source. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

Transcatheter Arterial Embolization for Gastrointestinal Bleeding Associated with Gastric Carcinoma: Prognostic Factors Predicting Successful Hemostasis and Survival.

PubMed

Park, Sangik; Shin, Ji Hoon; Gwon, Dong-Il; Kim, Hyoung Jung; Sung, Kyu-Bo; Yoon, Hyun-Ki; Ko, Gi-Young; Ko, Heung Kyu

2017-07-01

To evaluate outcomes of transcatheter arterial embolization (TAE) for gastric cancer-related gastrointestinal (GI) bleeding and factors associated with successful TAE and improved survival after TAE. This retrospective study included 43 patients (34 men; age 60.6 y ± 13.6) with gastric cancer-related GI bleeding undergoing angiography between January 2000 and December 2015. Clinical course, laboratory findings, and TAE characteristics were reviewed. Technical success of TAE was defined as target area devascularization, and clinical success was defined as bleeding cessation with hemodynamic stability during 72 hours after TAE. Student t test was used for comparison of continuous variables, and Fisher exact test was used for categorical variables. Univariate and multivariate analysis were performed to identify predictors of successful TAE and 30-day survival after TAE. TAE was performed in 40 patients. Technical and clinical success rates of TAE were 85.0% and 65.0%, respectively. Splenic infarction occurred in 2 patients as a minor complication. Rebleeding after TAE occurred in 7 patients. Death related to bleeding occurred in 5 patients. Active bleeding (P = .044) and higher transfusion requirement (3.3 U ± 2.6 vs 1.8 U ± 1.7; P = .039) were associated with TAE failure. Successful TAE predicted improved 30-day survival after TAE on univariate and multivariate analysis (P = .018 and P = .022; odds ratio, 0.132). TAE for gastric cancer-associated GI bleeding may be a lifesaving procedure. Severe bleeding with a higher transfusion requirement and active bleeding on angiography predicted TAE failure. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Two surgical procedures for esophagogastric variceal bleeding in patients with portal hypertension

PubMed Central

Yang, Lin; Yuan, Li-Juan; Dong, Rui; Yin, Ji-Kai; Wang, Qing; Li, Tao; Li, Jiang-Bin; Du, Xi-Lin; Lu, Jian-Guo

2013-01-01

AIM: To determine the clinical value of a splenorenal shunt plus pericardial devascularization (PCVD) in portal hypertension (PHT) patients with variceal bleeding. METHODS: From January 2008 to November 2012, 290 patients with cirrhotic portal hypertension were treated surgically in our department for the prevention of gastroesophageal variceal bleeding: 207 patients received a routine PCVD procedure (PCVD group), and 83 patients received a PCVD plus a splenorenal shunt procedure (combined group). Changes in hemodynamic parameters, rebleeding, encephalopathy, portal vein thrombosis, and mortality were analyzed. RESULTS: The free portal pressure decreased to 21.43 ± 4.35 mmHg in the combined group compared with 24.61 ± 5.42 mmHg in the PCVD group (P < 0.05). The changes in hemodynamic parameters were more significant in the combined group (P < 0.05). The long-term rebleeding rate was 7.22% in the combined group, which was lower than that in the PCVD group (14.93%), (P < 0.05). CONCLUSION: Devascularization plus splenorenal shunt is an effective and safe strategy to control esophagogastric variceal bleeding in PHT. It should be recommended as a first-line treatment for preventing bleeding in PHT patients when surgical interventions are considered. PMID:24409071

Impact of Anemia on Platelet Reactivity and Ischemic and Bleeding Risk: From the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents Study.

PubMed

Giustino, Gennaro; Kirtane, Ajay J; Baber, Usman; Généreux, Philippe; Witzenbichler, Bernhard; Neumann, Franz-Josef; Weisz, Giora; Maehara, Akiko; Rinaldi, Michael J; Metzger, Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Brodie, Bruce R; Stuckey, Thomas D; Gurbel, Paul A; Dangas, George D; Francese, Dominic P; Ozan, Ozgu; Mehran, Roxana; Stone, Gregg W

2016-06-15

Anemic patients remain at increased risk of ischemic and bleeding events. Whether the effects of hemoglobin levels on thrombotic and bleeding risk are independent of platelet reactivity on clopidogrel, however, remains unknown. Patients from the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents study were categorized by the presence of anemia at baseline, defined according the World Health Organization criteria. Platelet reactivity was measured with VerifyNow assay; high platelet reactivity (HPR) on clopidogrel was defined as platelet reactive units value >208. Of 8,413 patients included in the study cohort, 1,816 (21.6%) had anemia. HPR was more prevalent in patients with anemia (58.3% vs 38.4%; p <0.001), an association that persisted after multivariate adjustment (adjusted odds ratio: 2.04; 95% confidence interval [CI]: 1.82 to 2.29; p <0.0001). Patients with anemia had higher 2-year rates of major adverse cardiac events (9.5% vs 5.6%; p <0.0001), major bleeding (11.8% vs 7.7%; p <0.0001), and all-cause mortality (4.0% vs 1.4%; p <0.0001); however, after adjustment for baseline clinical confounders, including HPR, anemia was no longer significantly associated with major adverse cardiac events but was still independently associated with all-cause mortality (adjusted HR 1.61, 95% CI 1.23 to 2.12; p <0.0001) and major bleeding (adjusted HR 1.42, 95% CI 1.20 to 1.68; p <0.0001). The effect of HPR on clinical outcomes was uniform according to anemia status, without evidence of interaction. In conclusion, anemia independently correlated with HPR. After percutaneous coronary intervention with drug-eluting stents, anemia at baseline was significantly associated with higher 2-year hemorrhagic and mortality risk; conversely, its association with ischemic risk was attenuated after multivariate adjustment, including HPR. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial.

PubMed

Held, Claes; Hylek, Elaine M; Alexander, John H; Hanna, Michael; Lopes, Renato D; Wojdyla, Daniel M; Thomas, Laine; Al-Khalidi, Hussein; Alings, Marco; Xavier, Dennis; Ansell, Jack; Goto, Shinya; Ruzyllo, Witold; Rosenqvist, Mårten; Verheugt, Freek W A; Zhu, Jun; Granger, Christopher B; Wallentin, Lars

2015-05-21

In the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial, apixaban compared with warfarin reduced the risk of stroke, major bleed, and death in patients with atrial fibrillation. In this ancillary study, we evaluated clinical consequences of major bleeds, as well as management and treatment effects of warfarin vs. apixaban. Major International Society on Thrombosis and Haemostasis bleeding was defined as overt bleeding accompanied by a decrease in haemoglobin (Hb) of ≥2 g/dL or transfusion of ≥2 units of packed red cells, occurring at a critical site or resulting in death. Time to event [death, ischaemic stroke, or myocardial infarction (MI)] was evaluated by Cox regression models. The excess risk associated with bleeding was evaluated by separate time-dependent indicators for intracranial (ICH) and non-intracranial haemorrhage. Major bleeding occurred in 848 individuals (4.7%), of whom 126 (14.9%) died within 30 days. Of 176 patients with an ICH, 76 (43.2%) died, and of the 695 patients with major non-ICH, 64 (9.2%) died within 30 days of the bleeding. The risk of death, ischaemic stroke, or MI was increased roughly 12-fold after a major non-ICH bleeding event within 30 days. Corresponding risk of death following an ICH was markedly increased, with HR 121.5 (95% CI 91.3-161.8) as was stroke or MI with HR 21.95 (95% CI 9.88-48.81), respectively. Among patients with major bleeds, 20.8% received vitamin K and/or related medications (fresh frozen plasma, coagulation factors, factor VIIa) to stop bleeding within 3 days, and 37% received blood transfusion. There was no interaction between apixaban and warfarin and major bleeding on the risk of death, stroke, or MI. Major bleeding was associated with substantially increased risk of death, ischaemic stroke, or MI, especially following ICH, and this risk was similarly elevated regardless of treatment with apixaban or warfarin. These results underscore the importance of preventing bleeding in anti-coagulated patients. ClinicalTrials.gov Identifier: NCT00412984. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Management of Major Bleeding in Patients With Atrial Fibrillation Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]).

PubMed

Steinberg, Benjamin A; Simon, DaJuanicia N; Thomas, Laine; Ansell, Jack; Fonarow, Gregg C; Gersh, Bernard J; Kowey, Peter R; Mahaffey, Kenneth W; Peterson, Eric D; Piccini, Jonathan P

2017-05-15

Non-vitamin K antagonist oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the management of bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major bleeding in the setting of community use of NOACs. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry, we analyzed rates of International Society on Thrombosis and Haemostasis major bleeding and subsequent outcomes in patients treated with NOACs versus warfarin. Outcomes of interest included acute and chronic bleeding management, recurrent bleeding, thromboembolic events, and death. In total, 344 patients with atrial fibrillation experienced major bleeding events over a median follow-up of 360 days follow-up: n = 273 on NOAC (3.3 per 100 patient-years) and n = 71 on warfarin (3.5 per 100 patient-years). Intracranial bleeding was uncommon but similar (0.34 per 100 patient-years for NOAC vs 0.44 for warfarin, p = 0.5), as was gastrointestinal bleeding (1.8 for NOAC vs 1.3 for warfarin, p = 0.1). Blood products and correction agents were less commonly used in NOAC patients with major bleeds compared with warfarin-treated patients (53% vs 76%, p = 0.0004 for blood products; 0% vs 1.5% for recombinant factor; p = 0.0499); no patients received pharmacologic hemostatic agents (aminocaproic acid, tranexamic acid, desmopressin, aprotinin). Within 30 days, 23 NOAC-treated patients (8.4%) died versus 5 (7.0%) on warfarin (p = 0.7). At follow-up, 126 NOAC-treated (46%) and 29 warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major bleeding are similar in warfarin and NOAC-treated patients in clinical practice. However, NOAC-related bleeds require less blood product administration and rarely require factor replacement. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Microcoil Embolization for Acute Lower Gastrointestinal Bleeding

DOE Office of Scientific and Technical Information (OSTI.GOV)

D'Othee, Bertrand Janne, E-mail: bjanne@caregroup.harvard.edu; Surapaneni, Padmaja; Rabkin, Dmitry

2006-02-15

Purpose. To assess outcomes after microcoil embolization for active lower gastrointestinal (GI) bleeding. Methods. We retrospectively studied all consecutive patients in whom microcoil embolization was attempted to treat acute lower GI bleeding over 88 months. Baseline, procedural, and outcome parameters were recorded following current Society of Interventional Radiology guidelines. Outcomes included technical success, clinical success (rebleeding within 30 days), delayed rebleeding (>30 days), and major and minor complication rates. Follow-up consisted of clinical, endoscopic, and pathologic data. Results. Nineteen patients (13 men, 6 women; mean age {+-} 95% confidence interval = 70 {+-} 6 years) requiring blood transfusion (10 {+-}more » 3 units) had angiography-proven bleeding distal to the marginal artery. Main comorbidities were malignancy (42%), coagulopathy (28%), and renal failure (26%). Bleeding was located in the small bowel (n = 5), colon (n 13) or rectum (n = 1). Technical success was obtained in 17 patients (89%); 2 patients could not be embolized due to vessel tortuosity and stenoses. Clinical follow-up length was 145 {+-} 75 days. Clinical success was complete in 13 (68%), partial in 3 (16%), and failed in 2 patients (11%). Delayed rebleeding (3 patients, 27%) was always due to a different lesion in another bowel segment (0 late rebleeding in embolized area). Two patients experienced colonic ischemia (11%) and underwent uneventful colectomy. Two minor complications were noted. Conclusion. Microcoil embolization for active lower GI bleeding is safe and effective in most patients, with high technical and clinical success rates, no procedure-related mortality, and a low risk of bowel ischemia and late rebleeding.« less

Traditional Chinese Medicine herbs for stopping bleeding from haemorrhoids.

PubMed

Gan, Tao; Liu, Yue-Dong; Wang, Yiping; Yang, Jinlin

2010-10-06

Haemorrhoids is a common perianal disease, which often causes haematochezia. Besides a surgical operation or minimally invasive treatment, a variety of traditional Chinese medicinal herbs (TCMHs) have been used to treat bleeding haemorrhoids. To assess the effectiveness of traditional Chinese medicinal herbs for stopping bleeding from haemorrhoids and the adverse effects caused by these herbs. We searched the Cochrane Colorectal Cancer Group Trials Register, Cochrane Central Register of Contolled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CMCD (Chinese Medicine Conference Disc) and CBMD (Chinese Bio-Medicine Disc). All randomised clinical trials (RCTs) of Chinese herbs for bleeding haemorrhoids were included. Two authors independently extracted the data, which were analysed using RevMan 5.0 software. We estimated the relative risk for dichotomous data and calculated the weighted mean difference for continuous data. Nine trials involving 1822 patients with bleeding haemorrhoids were identified. The included trials were generally not of high quality and used one TCMH preparation compared with another TCMH preparation (Type I) (five trials) or western medicines (Type II) (four trials). We could not pool the data to perform a meta-analysis as only two of the included trials used the same intervention or comparison.In the nine trials, TCMHs showed a statistically significant difference for the improvement in the general curative effects or total grade of symptoms in six trials (P < 0.05; P < 0.01), of hematochezia in three trials (P < 0.05; P < 0.001), and of inflammation of perianal mucosa in one trial (P < 0.05). The adverse effects reported were not serious and were scarce. This review did not provide strong evidence concerning the effectiveness of TCMHs for stopping bleeding from haemorrhoids. Most of the included studies were of low quality and there was a scarcity of eligible trials and numbers of participants. Limited, weak evidence showed that some herbal formulae, when including Radix Sanguisorbae, Radix Rehmanniae, Fructus Sophorae, Radix Angelicae Sinensis, Radix Scutellariae, etc., may alleviate some symptoms caused by haemorrhoids. These include hematochezia, congestive haemorrhoidal cushions and inflammation of perianal mucosa in the short term. Well-designed clinical trials are required urgently before any confident conclusions can be drawn about the value of TCMHs for stopping bleeding from haemorrhoids.At present, the evidence is not enough that clinical practice should be changed immediately on the basis of these results.

Budesonide foam for mild to moderate distal ulcerative colitis: A systematic review and meta-analysis.

PubMed

Zeng, Jian; Lv, Lin; Mei, Zhe-Chuan

2017-03-01

Budesonide is a second-generation steroid with prominent topical effects and minimal systemic activity for patients with ulcerative colitis (UC). We perform a systematic review and meta-analysis of randomized placebo-controlled trials to assess the efficacy and safety of budesonide foam in mild-to-moderate distal UC. Comprehensive searches were performed to identify all eligible studies. Outcome measures were clinical remission, endoscopic improvement, elimination of rectal bleeding, and adverse events. The risk ratio (RR) with 95% confidence interval (CI) was estimated for each outcome. All statistical analyses were performed in STATA 12.0. Three randomized placebo-controlled trials recruiting 711 patients with mild-to-moderate distal UC were included in this study. No significant bias and heterogeneity was identified. Pooled analyses showed that budesonide foam was significantly superior to placebo for induction of clinical remission (RR = 1.83, 95%CI: 1.41, 2.37; P < 0.001) and endoscopic improvement (RR = 1.44, 95%CI: 1.23, 1.68; P < 0.001), and eliminating rectal bleeding at week 2 (RR = 2.00, 95%CI: 1.50, 2.66; P < 0.001), week 4 (RR = 1.73, 95%CI: 1.42, 2.12; P < 0.001), and week 6 (RR = 1.76, 95%CI: 1.45, 2.14; P < 0.001). No statistically significant difference was observed in the incidence of treatment-related adverse events and therapeutic discontinuation because of adverse events between budesonide foam and placebo. Budesonide foam is well tolerated and superior to placebo in inducing clinical remission and endoscopic improvement, and eliminating rectal bleeding for mild-to-moderate distal UC. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Fecal blood loss caused by two differently microencapsulated acetylsalicylic acid preparations in patients with rheumatoid arthritis. A prospective crossover study.

PubMed

Dirksen, A; Rasmussen, S N; Manthorpe, R

1982-01-01

In an investigator-blind crossover study, fecal blood loss determined by 51Cr-labelled red cells was measured in 17 male patients with rheumatoid arthritis and one with anchylosing spondylitis. In two periods, each of one week's duration and separated by a 3-week wash-out period, the patients received microencapsulated acetylsalicylic acid (ASA) 3 g daily--either iwht time-dependent (Acetard) or with pH-depeendent release (Reumyl). With the exception of one patient, who suffered clinically significant bleeding, both preparations produced only moderate bleeding. The bleeding provoked by ASA with pH-dependent release (median blood loss in ml/day: first period 1.6; last period 2.6) was less than with time-dependent release (first period 1.8; last period 3.5).

The Effects of the Contact Activation System on Hemorrhage

PubMed Central

Simão, Fabrício; Feener, Edward P.

2017-01-01

The contact activation system (CAS) exerts effects on coagulation via multiple mechanisms, which modulate both the intrinsic and extrinsic coagulation cascades as well as fibrinolysis and platelet activation. While the effects of the CAS on blood coagulation measured as activated partial thromboplastin time shortening are well documented, genetic mutations that result in deficiencies in the expression of either plasma prekallikrein (PPK) or factor XII (FXII) are not associated with spontaneous bleeding or increased bleeding risk during surgery. Deficiencies in these proteins are often undiagnosed for decades and detected later in life during routine coagulation assays without an apparent clinical phenotype. Increased interest in the CAS as a potentially safe target for antithrombotic therapies has emerged, in large part, from studies on animal models with provoked thrombosis, which have shown that deficiencies in PPK or FXII can reduce thrombus formation without increasing bleeding. Gene targeting and pharmacological studies in healthy animals have confirmed that PPK and FXII blockade does not cause coagulopathies. These findings support the conclusion that CAS is not required for hemostasis. However, while deficiencies in FXII and PPK do not significantly affect bleeding associated with peripheral wounds, recent reports have demonstrated that these proteins can promote hemorrhage in the retina and brain. Intravitreal injection of plasma kallikrein (PKal) induces retinal hemorrhage and intracerebral injection of PKal increases intracranial bleeding. PPK deficiency and PKal inhibition ameliorates hematoma formation following cerebrovascular injury in diabetic animals. Moreover, both PPK and FXII deficiency are protective against intracerebral hemorrhage caused by tissue plasminogen activator-mediated thrombolytic therapy in mice with thrombotic middle cerebral artery occlusion. Thus, while the CAS is not required for hemostasis, its inhibition may provide an opportunity to reduce hemorrhage in the retina and brain. Characterization of the mechanisms and potential clinical implications associated with the effects of the CAS on hemorrhage requires further consideration of the effects of PPK and FXII on hemorrhage beyond their putative effects on coagulation cascades. Here, we review the experimental and clinical evidence on the effects of the CAS on bleeding and hemostatic mechanisms. PMID:28824910

Pantoprazole before Endoscopy in Patients with Gastroduodenal Ulcer Bleeding: Does the duration of Infusion and Ulcer Location Influence the Effects?

PubMed Central

Rácz, Istvan; Szalai, Milan; Dancs, Nora; Kárász, Tibor; Szabó, Andrea; Csöndes, Mihaly; Horváth, Zoltan

2012-01-01

The aim of this study was to investigate the effect of preemptive pantoprazole infusion on early endoscopic findings in patients with acute ulcer bleeding. Records of 333 patients admitted with acute ulcer bleeding were analyzed. Ulcer bleeders were given either 80 mg bolus of pantoprazole followed by continuous infusion of 8 mg per hour or saline infusion until endoscopy. In 93 patients saline infusion whereas in 240 patients bolus plus infusion of pantoprazole was administrated with mean (±SD) durations of 5.45 ± 12.9 hours and 6.9 ± 13.2 hours, respectively (P = 0.29). Actively bleeding ulcers were detected in 46/240 (19.2%) of cases in the pantoprazole group as compared with 23/93 (24.7%) in the saline infusion group (P = 0.26). Different durations of pantoprazole infusion (0–4 hours, >4 hours, and >6 hours) had no significant effect on endoscopic and clinical outcome parameters in duodenal ulcer bleeders. Gastric ulcer bleeders on pantoprazole infusion longer than 4 and 6 hours before endoscopy had actively bleeding ulcers in 4.3% and 5% compared to the 19.5% active bleeding rate in the saline group (P = 0.02 and P = 0.04). Preemptive infusion of high-dose pantoprazole longer than 4 hours before endoscopy decreased the ratio of active bleeding only in gastric but not in duodenal ulcer patients. PMID:23125849

Optimal timing for performing hysterectomy according to different phase of menstrual cycle: Which is best?

PubMed

Kim, Jeong Jin; Kang, Jun Hyeok; Lee, Kyo Won; Kim, Kye Hyun; Song, Taejong

2017-05-01

The aim of this study was to determine whether the different phases of the menstrual cycle could affect operative bleeding in women undergoing laparoscopic hysterectomy. This was a retrospective comparative study. Based on the adjusted day of menstrual cycle, 212 women who underwent laparoscopic hysterectomy were classified into three groups: the follicular phase (n = 51), luteal phase group (n = 125), and menstruation group (n = 36). The primary outcome measure was the operative bleeding. There was no difference in the baseline characteristics of the patients belonging to the three groups. For the groups, there were no significant differences in operative bleeding (p = .469) and change in haemoglobin (p = .330), including operative time, length of hospital stay and complications. The menstrual cycle did not affect the operative bleeding and other parameters. Therefore, no phase of the menstrual cycle could be considered as an optimal timing for performing laparoscopic hysterectomy with minimal operative bleeding. Impact statement What is already known on this subject: the menstrual cycle results in periodic changes in haemostasis and blood flow in the reproductive organs. What the results of this study add: the menstrual cycle did not affect the operative bleeding and other operative parameters during laparoscopic hysterectomy. What the implications are of these findings for clinical practice and/or further research: no phase of the menstrual cycle could be considered as an optimal timing for performing laparoscopic hysterectomy with minimal operative bleeding.

Antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. People with liver disease frequently have haemostatic abnormalities such as hyperfibrinolysis. Therefore, antifibrinolytic amino acids have been proposed to be used as supplementary interventions alongside any of the primary treatments for upper gastrointestinal bleeding in people with liver diseases. This is an update of this Cochrane review. To assess the beneficial and harmful effects of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), LILACS (1982 to February 2015), World Health Organization Clinical Trials Search Portal (accessed 26 February 2015), and the metaRegister of Controlled Trials (accessed 26 February 2015). We scrutinised the reference lists of the retrieved publications. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. Observational studies for assessment of harms. We planned to summarise data from randomised clinical trials using standard Cochrane methodologies and assessed according to the GRADE approach. We found no randomised clinical trials assessing antifibrinolytic amino acids for treating upper gastrointestinal bleeding in people with acute or chronic liver disease. We did not identify quasi-randomised, historically controlled, or observational studies in which we could assess harms. This updated Cochrane review identified no randomised clinical trials assessing the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. The benefits and harms of antifibrinolytic amino acids need to be tested in randomised clinical trials. Unless randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

Inhibition of ADAMTS-13 by Doxycycline Reduces von Willebrand Factor Degradation During Supraphysiological Shear Stress: Therapeutic Implications for Left Ventricular Assist Device-Associated Bleeding.

PubMed

Bartoli, Carlo R; Kang, Jooeun; Restle, David J; Zhang, David M; Shabahang, Cameron; Acker, Michael A; Atluri, Pavan

2015-11-01

The aim of this study was to investigate a potential therapy for left ventricular assist device (LVAD)-associated bleeding. Nonsurgical bleeding is the most frequent complication of LVAD support. Recent evidence has demonstrated that supraphysiological shear stress from continuous-flow LVADs accelerates von Willebrand factor (vWF) metabolism by the action of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) (the vWF protease). An acquired vWF deficiency causes bleeding. This suggests that ADAMTS-13 is a clinical target to reduce vWF degradation. We tested the hypothesis that inhibition of ADAMTS-13 with doxycycline, an inexpensive, clinically approved drug, reduces vWF degradation during shear stress. Whole blood was collected from human donors (n = 15), and purified, recombinant ADAMTS-13 protein was obtained. An enzyme-linked immunosorbent assay (ELISA) was used to quantify the dose relationship between doxycycline and ADAMTS-13 activity prior to shear stress (n = 10). To determine the effect of shear stress, plasma and recombinant ADAMTS-13 were exposed to LVAD-like supraphysiological shear stress (approximately 175 dyne/cm(2)). vWF multimers and degradation fragments were characterized with electrophoresis and immunoblotting (n = 10). Förster resonance energy transfer was used to quantify plasma ADAMTS-13 activity (n = 10). An ELISA was used to quantify vWF:collagen binding activity. Platelet aggregometry was performed with adenosine 5'-diphosphate, collagen, and ristocetin (vWF-platelet pathway) agonism (n = 10). Doxycycline significantly decreased plasma ADAMTS-13 activity (p = 0.01) and the activity of recombinant human ADAMTS-13 protein by 21%. After plasma was exposed to shear stress, the same pattern of vWF degradation was observed as previously reported for LVAD patients, and vWF:collagen binding activity decreased significantly (p = 0.002). Doxycycline significantly decreased ADAMTS-13 activity (p = 0.04) and the activity of recombinant ADAMTS-13 by 18%, protected large vWF multimers from degradation, and significantly decreased the levels of the 5 smallest vWF fragments by 12 ± 2% (p < 0.05). As a result, vWF:collagen binding activity was significantly restored (p = 0.004). ADAMTS-13 inhibition with doxycycline did not hyperactivate platelets. Inhibition of ADAMTS-13 by doxycycline decreased vWF degradation and improved vWF function during supraphysiological shear stress without hyperactivating platelets. ADAMTS-13 is a clinical target to reduce vWF degradation, improve vWF function, and potentially reduce bleeding during LVAD support. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The portal hypertension syndrome: etiology, classification, relevance, and animal models.

PubMed

Bosch, Jaime; Iwakiri, Yasuko

2018-02-01

Portal hypertension is a key complication of portal hypertension, which is responsible for the development of varices, ascites, bleeding, and hepatic encephalopathy, which, in turn, cause a high mortality and requirement for liver transplantation. This review deals with the present day state-of-the-art preventative treatments of portal hypertension in cirrhosis according to disease stage. Two main disease stages are considered, compensated and decompensated cirrhosis, the first having good prognosis and being mostly asymptomatic, and the second being heralded by the appearance of bleeding or non-bleeding complications of portal hypertension. The aim of treatment in compensated cirrhosis is preventing clinical decompensation, the more frequent event being ascites, followed by variceal bleeding and hepatic encephalopathy. Complications are mainly driven by an increase of hepatic vein pressure gradient (HVPG) to values ≥10 mmHg (defining the presence of Clinically Significant Portal Hypertension, CSPH). Before CSPH, the treatment is limited to etiologic treatment of cirrhosis and healthy life style (abstain from alcohol, avoid/correct obesity…). When CSPH is present, association of a non-selective beta-blocker (NSBB), including carvedilol should be considered. NSBBs are mandatory if moderate/large varices are present. Patients should also enter a screening program for hepatocellular carcinoma. In decompensated patients, the goal is to prevent further bleeding if the only manifestation of decompensation was a bleeding episode, but to prevent liver transplantation and death in the common scenario where patients have manifested first non-bleeding complications. Treatment is based on the same principles (healthy life style..) associated with administration of NSBBs in combination if possible with endoscopic band ligation if there has been variceal bleeding, and complemented with simvastatin administration (20-40 mg per day in Child-Pugh A/B, 10-20 mg in Child C). Recurrence shall be treated with TIPS. TIPS might be indicated earlier in patients with: 1) Difficult/refractory ascites, who are not the best candidates for NSBBs, 2) patients having bleed under NSBBs or showing no HVPG response (decrease in HVPG of at least 20% of baseline or to values equal or below 12 mmHg). Decompensated patients shall all be considered as potential candidates for liver transplantation. Treatment of portal hypertension has markedly improved in recent years. The present day therapy is based on accurate risk stratification according to disease stage.

Is non‐steroidal anti‐inflammaory drug (NSAID) enteropathy clinically more important than NSAID gastropathy?

PubMed Central

Adebayo, D; Bjarnason, I

2006-01-01

The side effects of conventional non‐steroidal anti‐inflammatory drugs (NSAIDs) on the stomach is undoubtedly a serious public health problem contributing significantly to the morbidity and mortality of patients receiving these drugs. However, the damage of NSAIDs is not confined to the stomach. Indeed the short term and long term damage of NSAIDs on the small bowel (NSAID enteropathy) is more frequent than NSAID gastropathy. Furthermore, NSAID enteropathy is associated with complications (bleeding and protein loss). While many of these are mild, the serious events (significant bleeding, perforation, obstruction, and sudden death) are frequent as that reported for NSAID gastropathy. The diagnosis of NSAID enteropathy has been greatly aided by the introduction of wireless capsule enteroscopy. PMID:16517800

Is non-steroidal anti-inflammaory drug (NSAID) enteropathy clinically more important than NSAID gastropathy?

PubMed

Adebayo, D; Bjarnason, I

2006-03-01

The side effects of conventional non-steroidal anti-inflammatory drugs (NSAIDs) on the stomach is undoubtedly a serious public health problem contributing significantly to the morbidity and mortality of patients receiving these drugs. However, the damage of NSAIDs is not confined to the stomach. Indeed the short term and long term damage of NSAIDs on the small bowel (NSAID enteropathy) is more frequent than NSAID gastropathy. Furthermore, NSAID enteropathy is associated with complications (bleeding and protein loss). While many of these are mild, the serious events (significant bleeding, perforation, obstruction, and sudden death) are frequent as that reported for NSAID gastropathy. The diagnosis of NSAID enteropathy has been greatly aided by the introduction of wireless capsule enteroscopy.

Transjugular Intrahepatic Portosystemic Shunt Placement During Pregnancy: A Case Series of Five Patients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ingraham, Christopher R., E-mail: cringra@uw.edu; Padia, Siddharth A., E-mail: spadia@uw.edu; Johnson, Guy E., E-mail: gej@uw.edu

Background and AimsComplications of portal hypertension, such as variceal hemorrhage and ascites, are associated with significant increases in both mortality and complications during pregnancy. Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established procedure for treating portal hypertension, but the safety of TIPS during pregnancy is largely unknown. In this series, we review five patients who underwent TIPS placement while pregnant and describe their clinical outcomes.MethodsFive pregnant patients with cirrhosis and portal hypertension underwent elective TIPS for complications of portal hypertension (four for secondary prevention of variceal bleeding and one for refractory ascites). Outcomes measured were recurrent bleeding episodes or needmore » for further paracenteses during pregnancy, estimated radiation dose to the fetus and gestational age at delivery. All patients were followed after delivery to evaluate technical and clinical success of the procedure.ResultsAll five patients survived pregnancy and went on to deliver successfully. When TIPS was performed for secondary prevention of variceal bleeding (n = 4), no patients demonstrated variceal bleeding after TIPS placement. When TIPS was performed for refractory ascites (n = 1), no further paracenteses were required. All patients delivered successfully, albeit prematurely. Average radiation dose estimated to the fetus was 16.3 mGy.ConclusionsThis series suggests that TIPS can be performed in selective pregnant patients with portal hypertension, with little added risk to the mother or fetus.« less

Gastrointestinal bleeding risk of non-vitamin K oral anticoagulants is similar to warfarin - a Japanese retrospective cohort study
.

PubMed

Shirai, Tsuguru; Yamamoto, Takatsugu; Kawasugi, Kazuo; Kuyama, Yasushi; Kita, Hiroto

2016-11-01

Although several non-vitamin K oral anticoagulants have been developed to prevent cardiogenic thrombosis, the status of hemorrhagic complications in the clinical setting among Asian populations, including Japan, remains unclear. We conducted this retrospective cohort study to clarify the current status of hemorrhagic events during antithrombotic therapy with non-vitamin K oral anticoagulants, with particular focus on gastrointestinal bleeding. Medical charts of 475 patients prescribed dabigatran, rivaroxaban, or apixaban between April 2011 and September 2014 were reviewed to examine whether any hemorrhagic events occurred, compared with 135 patients who received warfarin between April 2009 and March 2011. Incidences of total and actionable hemorrhage in patient taking non-vitamin K oral anticoagulants were 13.8% per year and 4.6% per year, respectively, showing no significant differences from those in warfarin users (9.3% per year and 5.0% per year, respectively). In addition, actionable gastrointestinal hemorrhage occurred at similar rates in non-vitamin K oral anticoagulants users (2.1% per year) and warfarin users (1.5% per year). Most hemorrhages were from the lower gastrointestinal tract, and considerable events involved perianal bleeding. Multiple regression analysis showed that age, concomitant dual antiplatelet therapy, and concomitant nonsteroidal anti-inflammatory drug therapy were significant factors related to actionable gastrointestinal bleeding. Risk of gastrointestinal hemorrhage in patients taking non-vitamin K oral anticoagulants was similar to that in patients taking warfarin. The dominant bleeding site was the lower gastrointestinal tract.
.

Obstetric bleeding among women with inherited bleeding disorders: a retrospective study.

PubMed

Hawke, L; Grabell, J; Sim, W; Thibeault, L; Muir, E; Hopman, W; Smith, G; James, P

2016-11-01

Women with inherited bleeding disorders are at increased risk for bleeding complications during pregnancy and the postpartum period, particularly postpartum haemorrhage (PPH). This retrospective study evaluates pregnancy management through the Inherited Bleeding Disorders Clinic of Southeastern Ontario, the clinical factors associated with pregnancy-related abnormal bleeding and assesses tranexamic acid use in the postpartum treatment of bleeding disorder patients. A chart review of 62 pregnancies, from 33 women, evaluated patient characteristics (age, haemostatic factor levels) and delivery conditions (mode of delivery, postpartum treatment) in relation to abnormal postpartum bleeding. This cohort revealed increased risk of immediate PPH with increased age at delivery (mean age: 30.1 years with PPH, 26.5 years without PPH, P < 0.013), and birth by vaginal delivery (P < 0.042). Low von Willebrand factor (VWF) antigen or factor VIII (FVIII) in the third trimester was not associated with an increased risk of PPH; however, low VWF:RCo was associated with increased immediate PPH despite treatment with continuous factor infusion (P < 0.042). Women treated with tranexamic acid postpartum had less severe bleeding in the 6-week postpartum (P < 0.049) with no thrombotic complications. This study contributes to the growing body of work aimed at optimizing management of bleeding disorder patients through pregnancy and the postpartum period, showing patients are at a higher risk of PPH as they age. Risk factors such as low third trimester VWF:RCo have been identified. Treatment with tranexamic acid in the postpartum period is associated with a reduced incidence of abnormal postpartum bleeding. © 2016 John Wiley & Sons Ltd.

A simplified clinical risk score predicts the need for early endoscopy in non-variceal upper gastrointestinal bleeding.

PubMed

Tammaro, Leonardo; Buda, Andrea; Di Paolo, Maria Carla; Zullo, Angelo; Hassan, Cesare; Riccio, Elisabetta; Vassallo, Roberto; Caserta, Luigi; Anderloni, Andrea; Natali, Alessandro

2014-09-01

Pre-endoscopic triage of patients who require an early upper endoscopy can improve management of patients with non-variceal upper gastrointestinal bleeding. To validate a new simplified clinical score (T-score) to assess the need of an early upper endoscopy in non variceal bleeding patients. Secondary outcomes were re-bleeding rate, 30-day bleeding-related mortality. In this prospective, multicentre study patients with bleeding who underwent upper endoscopy were enrolled. The accuracy for high risk endoscopic stigmata of the T-score was compared with that of the Glasgow Blatchford risk score. Overall, 602 patients underwent early upper endoscopy, and 472 presented with non-variceal bleeding. High risk endoscopic stigmata were detected in 145 (30.7%) cases. T-score sensitivity and specificity for high risk endoscopic stigmata and bleeding-related mortality was 96% and 30%, and 80% and 71%, respectively. No statistically difference in predicting high risk endoscopic stigmata between T-score and Glasgow Blatchford risk score was observed (ROC curve: 0.72 vs. 0.69, p=0.11). The two scores were also similar in predicting re-bleeding (ROC curve: 0.64 vs. 0.63, p=0.4) and 30-day bleeding-related mortality (ROC curve: 0.78 vs. 0.76, p=0.3). The T-score appeared to predict high risk endoscopic stigmata, re-bleeding and mortality with similar accuracy to Glasgow Blatchford risk score. Such a score may be helpful for the prediction of high-risk patients who need a very early therapeutic endoscopy. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Incidence, risk factors, and prognosis of gastrointestinal hemorrhage complicating acute renal failure.

PubMed

Fiaccadori, E; Maggiore, U; Clima, B; Melfa, L; Rotelli, C; Borghetti, A

2001-04-01

Few prospective data are currently available on acute gastrointestinal hemorrhage (AGIH) as a complication of acute renal failure (ARF). The aim of the present study was to define incidence, sources, risk factors, and outcome of AGIH in patients with ARF. We performed a prospective study on an inception cohort of 514 patients admitted for ARF to a nephrology intermediate care unit. Data on clinical risk factors for bleeding, frequency of occurrence of AGIH, length of hospital stay, and in-hospital mortality were collected. Independent predictors of AGIH were identified. The relative odds of death and the relative increase in length of hospital stay associated with AGIH were calculated after adjusting for baseline comorbidities. Sixty-nine patients out of 514 [13.4% (95% CI, 10.6 to 16.7)] had AGIH as a complication of ARF; 59 were upper AGIH. Forty patients had clinically important bleeding. Erosions and/or ulcers accounted for 71% of cases of upper AGIH. Independent baseline predictors of AGIH were represented by severity of illness [odds ratio 1.45 (95% CI, 1.05 to 2.01) for every 10 point increase in APACHE II score], low platelet count [<50,000 mm3; 3.71 (1.70 to 8.11)], noncirrhotic chronic hepatic disease [2.22 (1.09 to 4.55)], liver cirrhosis [3.38 (1.50 to 7.60)], de novo ARF [2.77 (1.30 to 5.90)], and severe ARF [2.07 (1.10 to 3.88)]. In-hospital mortality was 63.8% in patients with AGIH and 34.2% in the other patients; after adjusting for baseline confounders, AGIH remained significantly associated with an increase in both mortality [2.57 (1.30 to 5.09), P = 0.006] and length of hospital stay [37% (1 to 87%), P = 0.047]. AGIH and clinically important bleeding are frequent complications of ARF. In this clinical condition, AGIH is more often due to upper gastrointestinal bleeding and is associated with a significantly increased risk of death and length of hospital stay. Both renal and extrarenal risk factors are related to the occurrence of AGIH.

Bleeding Duodenal: Varices Treatment by TIPS and Transcatheter Embolization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lopera, Jorge E.; Arthurs, Blain; Scheuerman, Christian

2008-03-15

We describe our clinical experience in 4 patients with portal hypertension who presented with bleeding mesenteric varices originating from the superior mesenteric vein with retrograde filling of collaterals draining into the inferior vena cava. The clinical presentation, imaging findings, and potential therapeutic management are discussed.

Transarterial embolization for the treatment of massive bleeding in gynecologic and obstetric emergencies: a single center experience.

PubMed

Hongsakul, Keerati; Songjamrat, Apiradee; Rookkapan, Sorracha

2014-08-01

Delayed treatment of the massive bleeding in gynecologic and obstetric conditions can cause high morbidity and mortality. The aim of this study is to assess the angiographic findings and outcomes of transarterial embolization in cases of massive hemorrhage from underlying gynecological and obstetrical conditions. This is a retrospective study of 18 consecutive patients who underwent transarterial embolization of uterine and/or hypogastric arteries due to massive bleeding from gynecological and obstetrical causes from January 2006 to December 2011. The underlying causes of bleeding, angiographic findings, technical success rates, clinical success rates, and complications were evaluated. Massive gynecological and obstetrical bleeding occurred in 12 cases and 6 cases, respectively. Gestational trophoblastic disease was the most common cause of gynecological bleeding. The most common cause of obstetrical hemorrhage was primary post-partum hemorrhage. Tumor stain was the most frequent angiographic finding (11 cases) in the gynecological bleeding group. The most common angiographic findings in obstetrical patients were extravasation (2 cases) and pseudoaneurysm (2 cases). Technical and final clinical success rates were found in all 18 cases and 16 cases. Collateral arterial supply, severe metritis, and unidentified cervical laceration were causes of uncontrolled bleeding. Only minor complications occurred, which included pelvic pain and groin hematoma. Percutaneous transarterial embolization is a highly effective and safe treatment to control massive bleeding in gynecologic and obstetric emergencies.

Circadian occurrence of variceal bleeding in patients with liver cirrhosis.

PubMed

Siringo, S; Bolondi, L; Sofia, S; Hermida, R C; Gramantieri, L; Gaiani, S; Piscaglia, F; Carbone, C; Misitano, B; Corinaldesi, R

1996-12-01

Several clinical events have a rhythmicity over the 24 h period. We assessed the presence of periodic rhythm in the occurrence of haematemesis in patients with liver cirrhosis under different daylight regimens, namely during standard time and during daylight savings. Over a 48 month period there were 212 consecutive admissions of 118 cirrhotics with variceal bleeding. Complete data were available for 181 episodes of bleeding: 121 (66.9%) started with haematemesis and 60 (33.1%) started with melaena. One hundred and two (56%) episodes occurred during daylight savings and 79 (44%) occurred during standard time. The cosinor test showed a 24 h biphasic peak for the occurrence of haematemesis (09.45 and 21.45 h). Moreover, a biphasic diurnal asymmetric frequency was also found by multiple component rhythmometry. The time peaks of onset of variceal haemorrhage did not change significantly during standard time and daylight savings. Patients with more than one haematemesis episode significantly bled over the same time interval. The present study confirms that over the 24 h period variceal bleeding in cirrhotic patients occurs with a predictable rhythmicity that does not seem to be under the control of the light-dark cycle. The finding of a chronorisk for variceal haemorrhage addresses specific questions for pathophysiological studies as well as for new treatment strategies.

International recommendations on the diagnosis and treatment of patients with acquired hemophilia A

PubMed Central

Huth-Kühne, Angela; Baudo, Francesco; Collins, Peter; Ingerslev, Jørgen; Kessler, Craig M.; Lévesque, Hervé; Castellano, Maria Eva Mingot; Shima, Midori; St-Louis, Jean

2009-01-01

Acquired hemophilia A (AHA) is a rare bleeding disorder characterized by autoantibodies directed against circulating coagulation factor (F) VIII. Typically, patients with no prior history of a bleeding disorder present with spontaneous bleeding and an isolated prolonged aPTT. AHA may, however, present without any bleeding symptoms, therefore an isolated prolonged aPTT should always be investigated further irrespective of the clinical findings. Control of acute bleeding is the first priority, and we recommend first-line therapy with bypassing agents such as recombinant activated FVII or activated prothrombin complex concentrate. Once the diagnosis has been achieved, immediate autoantibody eradication to reduce subsequent bleeding risk should be performed. We recommend initial treatment with corticosteroids or combination therapy with corticosteroids and cyclophosphamide and suggest second-line therapy with rituximab if first-line therapy fails or is contraindicated. In contrast to congenital hemophilia, no comparative studies exist to support treatment recommendations for patients with AHA, therefore treatment guidance must rely on the expertise and clinical experience of specialists in the field. The aim of this document is to provide a set of international practice guidelines based on our collective clinical experience in treating patients with AHA and contribute to improved care for this patient group. PMID:19336751

An updated concept of coagulation with clinical implications.

PubMed

Romney, Gregory; Glick, Michael

2009-05-01

Over the past century, a series of models have been put forth to explain the coagulation mechanism. The coagulation cascade/waterfall model has gained the most widespread acceptance. This model, however, has problems when it is used in different clinical scenarios. A more recently proposed cell-based model better describes the coagulation process in vivo and provides oral health care professionals (OHCPs) with a better understanding of the clinical implications of providing dental care to patients with potentially increased bleeding tendencies. The authors conducted a literature search using the PubMed database. They searched for key words including "coagulation," "hemostasis," "bleeding," "coagulation factors," "models," "prothrombin time," "activated partial thromboplastin time," "international normalized ratio," "anticoagulation therapy" and "hemophilia" separately and in combination. The coagulation cascade/waterfall model is insufficient to explain coagulation in vivo, predict a patient's bleeding tendency, or correlate clinical outcomes with specific laboratory screening tests such as prothrombin time, activated partial thromboplastin time and international normalized ratio. However, the cell-based model of coagulation that reflects the in vivo process of coagulation provides insight into the clinical ramifications of treating dental patients with specific coagulation factor deficiencies. Understanding the in vivo coagulation process will help OHCPs better predict a patient's bleeding tendency. In addition, applying the theoretical concept of the cell-based model of coagulation to commonly used laboratory screening tests for coagulation and bleeding will result in safer and more appropriate dental care.

Management of Major Bleeding Events in Patients Treated With Dabigatran for Nonvalvular Atrial Fibrillation: A Retrospective, Multicenter Review.

PubMed

Milling, Truman J; Fromm, Christian; Ganetsky, Michael; Pallin, Daniel J; Cong, Julie; Singer, Adam J

2017-05-01

There are limited data on the clinical presentations and management of dabigatran-associated major bleeding outside the clinical trial setting. The aim of this study is to describe clinical characteristics, interventions, and outcomes in patients with dabigatran-associated major bleeding who present to the emergency department (ED). We performed a retrospective observational chart review study of dabigatran-treated patients with nonvalvular atrial fibrillation who presented with acute major bleeding to the ED. We searched electronic medical record databases cross-referencing medication lists and hemorrhage International Classification of Diseases, Ninth Revision (ICD-9) and ICD-10 codes. We studied the resulting charts to yield confirmed nonvalvular atrial fibrillation in patients with an index event of major bleeding and at least 1 dose of dabigatran in the 5 preceding days. The electronic search yielded 284 cases, and we assessed 93 as ineligible, leaving 191 in the final cohort. Of these, 118 patients (62%) had gastrointestinal hemorrhage; 36 (19%) had intracranial hemorrhage, 8 (4%) of which were nontraumatic cases and 28 (15%) traumatic. Thirty-six (19%) of the index events were in "other" locations and 1 (0.5%) "unknown." There were 12 deaths (6%): 8 from patients presenting with gastrointestinal bleeding events, 2 from intracranial hemorrhage (both nontraumatic), and 2 from other. Although RBC and plasma transfusions were common, only 11 patients (6%) received purified coagulation factors. Despite rare use of reversal strategies, mortality was low and outcomes were favorable, similar to reported outcomes from clinical trials, in this sample of patients with major bleeding while receiving dabigatran. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

A new progestogen-only medical therapy for outpatient management of acute, abnormal uterine bleeding: a pilot study.

PubMed

Ammerman, Stacy R; Nelson, Anita L

2013-06-01

The objective of this investigation was to study short-term efficacy and feasibility of a new progestogen-only treatment for outpatient management of acute abnormal uterine bleeding. This was a prospective, single-arm, pilot clinical trial of a progestogen-only bridging treatment for acute abnormal uterine bleeding in nonpregnant, premenopausal women in the Gynecologic Urgent Care Clinic at Harbor-UCLA Medical Center. Subjects were administered a depo-medroxyprogesterone acetate 150 mg intramuscular injection and given medroxyprogesterone acetate 20 mg to be taken orally every 8 hours for 3 days. The primary outcome measures included a percentage of women who stopped bleeding in 5 days, time to bleeding cessation, reduction in numbers of pads used, side effects, and patient satisfaction. All 48 women stopped bleeding within 5 days; 4 women had spotting only at the time of their last contact during the 5 day follow-up. Mean time to bleeding cessation was 2.6 days. Side effects were infrequent and patient satisfaction was high. Injection of depo-medroxyprogesterone acetate 150 mg intramuscularly combined with 3 days of oral medroxyprogesterone acetate 20 mg every 8 hours for 9 doses is an effective outpatient therapy for acute abnormal uterine bleeding. Copyright © 2013 Mosby, Inc. All rights reserved.

Reversal of Direct Oral Anticoagulants: Current Status and Future Directions.

PubMed

Weitz, Jeffrey I

2017-02-01

Direct oral anticoagulants (DOACs) are increasingly used for prevention and treatment of venous thromboembolism and for prevention of stroke in patients with nonvalvular atrial fibrillation. In phase III clinical trials that included more than 100,000 patients, the DOACs were at least as effective as vitamin K antagonists (VKAs) and were associated with less serious bleeding, particularly less intracranial bleeding. Real-world evidence supports these outcomes. Despite this, some physicians and patients are concerned about serious bleeding or emergencies unless specific reversal agents for the DOACs are available. However, in clinical trials performed without reversal agents, the outcome of major bleeds was similar or better in patients receiving DOACs than in those taking VKAs. Because of their short half-lives, supportive measures are sufficient to manage most bleeds in patients receiving DOACs. Anticoagulant reversal should only be considered with life-threatening bleeds, with bleeds that fail to respond to usual measures and in patients requiring urgent surgery. Idarucizumab is licensed for dabigatran reversal and andexanet alfa is likely to be soon licensed for reversal of rivaroxaban, apixaban, and edoxaban. To ensure responsible use of these agents, every hospital needs a bleeding management algorithm that identifies patients eligible for reversal and outlines appropriate dosing regimens. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

F7 gene variants modulate protein levels in a large cohort of patients with factor VII deficiency. Results from a genotype-phenotype study.

PubMed

Quintavalle, Gabriele; Riccardi, Federica; Rivolta, Gianna Franca; Martorana, Davide; Di Perna, Caterina; Percesepe, Antonio; Tagliaferri, Annarita

2017-08-01

Congenital factor VII (FVII) deficiency is a rare bleeding disorder caused by mutations in F7 gene with autosomal recessive inheritance. A clinical heterogeneity with poor correlation with FVII:C levels has been described. It was the objective of this study to identify genetic defects and to evaluate their relationships with phenotype in a large cohort of patients with FVII:C<50 %. One hundred twenty-three probands were genotyped for F7 mutations and three polymorphic variants and classified according to recently published clinical scores. Forty out of 123 patients (33 %) were symptomatic (43 bleedings). A severe bleeding tendency was observed only in patients with FVII:C<0.10 %. Epistaxis (11 %) and menorrhagia (32 % of females in fertile age) were the most frequent bleedings. Molecular analysis detected 48 mutations, 20 not reported in the F7 international databases. Most mutations (62 %) were missense, large deletions were 6.2 %. Compound heterozygotes/homozygotes for mutations presented lower FVII:C levels compared to the other classes (Chi 2 =43.709, p<0,001). The polymorphisms distribution was significantly different among the three F7 genotypic groups (Chi 2 =72.289, p<0,001). The presence of truncating mutations was associated with lowest FVII:C levels (Chi 2 =21.351, p=0.002). This study confirms the clinical and molecular variability of the disease and the type of symptoms. It shows a good correlation between the type of F7 mutation and/or polymorphisms and FVII:C levels, without a direct link between FVII:C and bleeding tendency. The results suggest that large deletions are underestimated and that they represent a common mechanism of F7 gene inactivation which should always be investigated in the diagnostic testing for FVII deficiency.

Anemia in patients with acute coronary syndromes treated with prasugrel or ticagrelor: Insights from the RENAMI registry.

PubMed

Guerrero, Carme; Garay, Alberto; Ariza-Solé, Albert; Formiga, Francesc; Raposeiras-Roubín, Sergio; Abu-Assi, Emad; D'Ascenzo, Fabrizio; Kinnaird, Timm; Manzano-Fernández, Sergio; Alegre, Oriol; Sánchez-Salado, José C; Lorente, Victòria; Templin, Christian; Velicki, Lazar; Xanthopoulou, Ioanna; Cerrato, Enrico; Rognoni, Andrea; Boccuzzi, Giacomo; Omedè, Pierluigi; Montabone, Andrea; Taha, Salma; Durante, Alessandro; Gili, Sebastiano; Magnani, Giulia; Conrotto, Federico; Bertaina, Maurizio; Autelli, Michele; Grosso, Alberto; Blanco, Pedro Flores; Quadri, Giorgio; Varbella, Ferdinando; Tomassini, Francesco; Queija, Berenice Caneiro; Paz, Rafael Cobas; Fernández, María Cespón; Pousa, Isabel Muñoz; Gallo, Diego; Morbiducci, Umberto; Dominguez-Rodriguez, Alberto; Valdés, Mariano; Alexopoulos, Dimitrios; Iñiguez-Romo, Andrés; Gaita, Fiorenzo; Cequier, Ángel

2018-05-22

Ticagrelor and prasugrel are recommended as first line therapy in patients with acute coronary syndromes (ACS). However, patients with anemia are commonly treated with clopidogrel in routine clinical practice. The RENAMI registry (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction) included ACS patients treated with prasugrel or ticagrelor at hospital discharge. The aim of this study was to analyze the prevalence of anemia and characteristics and outcomes of these patients according to anemia status. Consecutive patients with ACS from 11 centers were included. All patients underwent percutaneous coronary intervention (PCI). Anemia was defined as hemoglobin <130 g/L in men and <120 g/L in women. The incidence of ischemic and bleeding events and all-cause mortality were assessed at one year. From 4424 patients included, 405 (9.2%) fulfilled criteria of anemia. Patients with anemia were significantly older, had a higher prevalence of peripheral artery disease, previous bleeding and renal disfunction and higher bleeding risk (PRECISE-DAPT score ≥ 25: 37.3% vs 18.8%, p < 0.001) The incidence of BARC 3/5 bleeding was moderately higher in patients with anemia (5.4% vs 1.5%, p = 0.001). The incidence of stent thrombosis or reinfarction was not significantly different according to anemia status. Anemia was independently associated with mortality (HR 1.73; 95% CI 1.03-2.91, p = 0.022). A not negligible proportion of patients treated with ticagrelor or prasugrel met criteria for anemia. Anemia was an independent predictor of mortality. Despite their higher bleeding risk profile, patients with anemia had an acceptable rate of bleeding. Copyright © 2018 Elsevier Ltd. All rights reserved.

Estimation of the impact of warfarin's time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials.

PubMed

Amin, Alpesh; Deitelzweig, Steve; Jing, Yonghua; Makenbaeva, Dinara; Wiederkehr, Daniel; Lin, Jay; Graham, John

2014-01-01

Warfarin's time-in-therapeutic range (TTR) is highly variable among patients with nonvalvular atrial fibrillation (NVAF). The objective of this study was to estimate the impact of variations in wafarin's TTR on rates of stroke/systemic embolism (SSE) and major bleedings among NVAF patients in the ARISTOTLE, ROCKET-AF, and RE-LY trials. Additionally, differences in medical costs for clinical endpoints when novel oral anticoagulants (NOACs) were used instead of warfarin at different TTR values were estimated. Quartile ranges of TTR values and corresponding event rates (%/patient - year = %/py) of SSE and major bleedings among NVAF patients treated with warfarin were estimated from published literature and FDA documents. The associations of SSE and major bleeding rates with TTR values were evaluated by regression analysis and then the calculated regression coefficients were used in analysis of medical cost differences associated with use of each NOAC versus warfarin (2010 costs; US payer perspective) at different TTRs. Each 10 % increase in warfarin's TTR correlated with a -0.32%/py decrease in SSE rate (R(2) = 0.61; p < 0.001). Although, the rate of major bleedings decreased as TTR increased, it was not significant (-0.035%/py, p = 0.63). As warfarin's TTR increased from 30 to 90% the estimated medical cost decreased from -$902 to -$83 for apixaban, from -$506 to +$314 for rivaroxaban, and from -$596 to +$223 for dabigatran. Among NVAF patients there is a significant negative correlation between warfarin's TTR and SSE rate, but not major bleedings. The variations in warfarin's TTR impacted the economic comparison of use of individual NOACs versus warfarin.

Use of a transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer.

PubMed

Zhao, Wen-Tao; Hu, Feng-Liang; Li, Yu-Ying; Li, Hong-Jie; Luo, Wei-Ming; Sun, Feng

2013-01-01

The aim of the present study was to investigate the usefulness of the transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer. Between January 2007 and May 2011 a nonrandomized prospective study of patients undergoing anterior resection for rectal cancer was done. The patients were divided into the transanal drainage tube (TDT) and non-transanal drainage tube (NTDT) groups according to whether the transanal drainage tube was used in the operation. Clinical characteristics and postoperative complications were compared between the TDT and NTDT groups. The study included 81 patients in the TDT group and 77 patients in the NTDT group. In the TDT group, anastomotic leakage occurred in 2 patients and no anastomotic bleeding occurred. In the NTDT group, anastomotic leakage occurred in 7 patients and anastomotic bleeding occurred in 2 patients. The TDT group had significantly fewer anastomotic complications compared with the NTDT group (2.5 vs 11.7 %; P = 0.029). Furthermore, the TDT group showed an obvious reduction in the rate of anastomotic leakage and anastomotic bleeding compared with the NTDT group (2.5 vs 7.8 % and 0.0 vs 2.6 %), but because the number of cases is relatively small, the difference did not reach statistical significance (P = 0.160 and P = 0.236). The use of a transanal drainage tube in anterior resection for rectal cancer may be a simple, safe, and effective means of preventing or reducing the occurrence of anastomotic leakage and bleeding. A larger-scale single or multi-center prospective randomized study or a meta-analysis including similar studies is necessary for further elucidation of this issue.

Bleeding after tooth extraction in patients taking aspirin and clopidogrel (Plavix®) compared with healthy controls.

PubMed

Sadeghi-Ghahrody, Mohsen; Yousefi-Malekshah, Seyed Hamid; Karimi-Sari, Hamidreza; Yazdanpanah, Hamid; Rezaee-Zavareh, Mohammad Saeid; Yavarahmadi, Mohammadhosein

2016-06-01

The risk of perioperative bleeding is high in patients who take aspirin and clopidogrel after a percutaneous coronary intervention, and whether to stop the drugs is a matter of concern for dentists. The aim of this study was to answer the specific question: should aspirin and clopidogrel bisulphate (Plavix®) be discontinued during a conventional forceps extraction? We studied 64 patients during the first year after percutaneous insertion of coronary stents who were taking aspirin (ASA) 80mg and clopidogrel (Plavix(®)) 75mg, and 50 healthy patients who were to have a conventional forceps extraction at this polyclinic in 2013-2014 and acted as controls. Clinical details (underlying diseases; number of roots; type of tooth; type of haemostasis; and bleeding immediately, 30minutes, and 48hours after intervention) were compared. We evaluated 114 patients with the mean (range) age of 56 (43-76) years, and there were no significant differences in demographic data, underlying diseases, type of tooth, number of roots, and dose of anaesthetic between the groups. There were also no significant differences in the number of bleeds immediately and 30minutes after intervention (P=0.310 and 0.205). The time that the last dose of aspirin had been taken correlated with 30-minute haemostasis (20 compared with 12hours, p=0.037). During the 48hours after the intervention, there were no uncontrolled bleeds or emergency referrals. We conclude that using aspirin and Plavix® simultaneously has no considerable effect on the risk of bleeding in patients having conventional forceps extraction of a single tooth. Copyright © 2016 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Iron Deficiency without Anemia: A Common Yet Under-Recognized Diagnosis in Young Women with Heavy Menstrual Bleeding.

PubMed

Johnson, Stephen; Lang, Abigail; Sturm, Mollie; O'Brien, Sarah H

2016-12-01

To assess the proportion of iron deficiency that is not detected with a screening hemoglobin or complete blood count (CBC) alone in young women with heavy menstrual bleeding. Retrospective review of electronic medical records. Nationwide Children's Hospital in Columbus, Ohio. One hundred fourteen young women aged 9-19 years consecutively referred to a young women's hematology clinic with a complaint of heavy menstrual bleeding. Fifty-eight (50.9%) of all patients had ferritin <20 ng/mL indicating iron deficiency. Of the 58 patients with iron deficiency, only 24 (41.4%) were anemic and 25 (46.3%) were microcytic. The sensitivity of hemoglobin alone and CBC alone for identifying women with ferritin <20 ng/mL was 41.4% (95% confidence interval [CI], 28.7-54.1) and 46.3% (95% CI, 33.0-59.6), respectively. Both tests had reasonable specificity at 91.1% (95% CI, 83.6-98.5) for hemoglobin and 83.9% for CBC (95% CI, 74.3-93.6). Patients had significantly higher odds of having iron deficiency if they were overweight or obese (odds ratio, 2.81; 95% CI, 1.25-6.29) compared with patients with normal body mass index. Age at presentation for heavy menstrual bleeding, presence of an underlying bleeding disorder, and median household income were not significantly associated with iron deficiency. In adolescents with heavy menstrual bleeding, fewer than half of iron deficiency cases are detected when screening is performed with hemoglobin or blood count alone. Measuring ferritin levels in at-risk patients might allow for earlier implementation of iron therapy and improvement in symptoms. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Development and implementation of a novel immune thrombocytopenia bleeding score for dogs.

PubMed

Makielski, Kelly M; Brooks, Marjory B; Wang, Chong; Cullen, Jonah N; O'Connor, Annette M; LeVine, Dana N

2018-04-21

A method of quantifying clinical bleeding in dogs with immune thrombocytopenia (ITP) is needed because ITP patients have variable bleeding tendencies that inconsistently correlate with platelet count. A scoring system will facilitate patient comparisons and allow stratification based on bleeding severity in clinical trials. To develop and evaluate a bleeding assessment tool for dogs, and a training course for improving its consistent implementation. Client-owned dogs (n = 61) with platelet counts <50,000/μL; 34 classified as primary ITP, 17 as secondary ITP, and 10 as non-ITP. A novel bleeding assessment tool, DOGiBAT, comprising bleeding grades from 0 (none) to 2 (severe) at 9 anatomic sites, was developed. Clinicians and technicians completed a training course and quiz before scoring thrombocytopenic patients. The training course was assessed by randomizing student volunteers to take the quiz with or without prior training. A logistic regression model assessed the association between training and quiz performance. The correlation of DOGiBAT score with platelet count and outcome measures was assessed in the thrombocytopenic dogs. Clinicians and technicians consistently applied the DOGiBAT, correctly scoring all quiz cases. The odds of trained students answering correctly were higher than those of untrained students (P < .0001). In clinical cases, DOGiBAT score and platelet count were inversely correlated (r s  = -0.527, P < .0001), and DOGiBAT directly correlated with transfusion requirements (r s  = 0.512, P < .0001) and hospitalization duration (r s  = 0.35, P = .006). The DOGiBAT and assessment quiz are simple tools to standardize evaluation of bleeding severity. With further validation, the DOGiBAT may provide a clinically relevant metric to characterize ITP severity and monitor response in treatment trials. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

A combination of alleles 2 of interleukin (IL)-1A(-889) and IL-1B(+3954) is associated with lower gingival bleeding tendency in plaque-induced gingivitis in young adults of Arabic heritage.

PubMed

Müller, H P; Barrieshi-Nusair, K M

2007-09-01

The aim of this study was to investigate the possible association of a distinct combination of polymorphisms in the interleukin (IL)-1 gene cluster on gingival bleeding tendency in young adult Arabs with plaque-induced gingivitis. Fifty otherwise healthy, nonsmoking volunteers, 19-28 years of age, participated. Clinical examinations included periodontal probing depth, bleeding on probing, and plaque index. Probing was done with a pressure-controlled probe at about 1.27 MPa. Examinations were repeated after 2 and 4 weeks. Polymorphisms in the IL-1 gene cluster were assessed using a reverse hybridization assay. A subject carrying alleles 2 at IL-1A ( -889 ) and IL-1B ( +3954 ) was designated genotype-positive. Twenty-six subjects were genotype-positive (52%). A repeated measures two-level (occasion, subject) model of the proportion of sites bleeding on probing, which was adjusted for gender, average plaque index, probing depth, and calculus, revealed a significantly lower proportion of bleeding sites in genotype-positive subjects (estimate -0.050, standard error 0.025, p < 0.05). Biserial correlations of bleeding proportions were high (0.71-0.78), confirming the steady-state plaque environment. It was concluded that inflammatory responses to dental plaque were considerably dampened in genotype-positive, nonsmoking young adults of Arabic heritage.

Detection of mild inherited disorders of blood coagulation: current options and personal recommendations.

PubMed

Lippi, Giuseppe; Pasalic, Leonardo; Favaloro, Emmanuel J

2015-08-01

Although assessment of prior personal and familial bleeding history is an important aspect of the diagnosis of bleeding disorders, patients with mild inherited bleeding disorders are sometimes clinically asymptomatic until presented with a hemostatic challenge. However, bleeding may occur after incursion of trauma or surgery, so detection of these conditions reflects an important facet of clinical and laboratory practice. Mild bleeding disorders may be detected as a result of family studies or following identification of abnormal values in first-line screening tests such as activated partial thromboplastin time, prothrombin time, fibrinogen and global platelet function screen testing, such as the platelet function analyzer. Following determination of abnormal screening tests, subsequent investigation should follow a systematic approach that targets specific diagnostic tests, and including factor assays, full platelet function assays and more extensive specialized hemostasis testing. The current report provides a personal overview on inherited disorders of blood coagulation and their detection.

Haematology and coagulation profiles in cats with congenital portosystemic shunts.

PubMed

Tzounos, Caitlin E; Tivers, Michael S; Adamantos, Sophie E; English, Kate; Rees, Alan L; Lipscomb, Vicky J

2017-12-01

Objectives The objectives of this study were, first, to report the haematological parameters and coagulation times for cats with a congenital portosystemic shunt (CPSS) and the influence of surgical shunt attenuation on these parameters; and, second, to identify any association between prolongation in coagulation profiles and incidence of perioperative haemorrhage. Methods This was a retrospective clinical study using client-owned cats with a CPSS. Signalment, shunt type (extra- or intrahepatic), degree of shunt attenuation (complete or partial), haematological parameters, prothrombin time (PT) and activated partial thromboplastin time (aPTT) test results, and occurrence of any perioperative clinical bleeding complications were recorded for cats undergoing surgical treatment of a CPSS at the Royal Veterinary College, UK, between 1994 and 2011. Results Forty-two cats were included. Thirty-six (85.7%) had an extrahepatic CPSS and six (14.3%) had an intrahepatic CPSS. Preoperatively, mean cell volume (MCV) and mean cell haemoglobin (MCH) were below the reference interval (RI) in 32 (76.2%) and 31 (73.8%) cats, respectively. Red blood cell count and mean cell haemoglobin concentration (MCHC) were above the RI in 10 (23.8%) and eight (19.1%) cats, respectively. Postoperatively, there were significant increases in haematocrit ( P = 0.044), MCV ( P = 0.008) and MCH ( P = 0.002). Despite the significant increase in MCV postoperatively, the median MCV postoperatively was below the RI, indicating persistence of microcytosis. Preoperatively, PT was above the upper RI in 14 cats (87.5%), and aPTT was above the upper RI in 11 cats (68.8%). No cat demonstrated a perioperative clinical bleeding complication. Conclusions and relevance Cats with a CPSS are likely to present with a microcytosis, but rarely present with anaemia, leukocytosis or thrombocytopenia. Surgical attenuation of the CPSS results in a significant increase in the HCT and MCV. Coagulation profiles in cats with a CPSS are likely to be prolonged, irrespective of shunt type, but do not appear to be associated with an increased risk of clinical bleeding.

Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System.

PubMed

Gutmann, Anja; Kaier, Klaus; Sorg, Stefan; von Zur Mühlen, Constantin; Siepe, Matthias; Moser, Martin; Geibel, Annette; Zirlik, Andreas; Ahrens, Ingo; Baumbach, Hardy; Beyersdorf, Friedhelm; Vach, Werner; Zehender, Manfred; Bode, Christoph; Reinöhl, Jochen

2015-01-20

This study aims at analyzing complication-induced additional costs of patients undergoing transcatheter aortic valve replacement (TAVR). In a prospective observational study, a total of 163 consecutive patients received either transfemoral (TF-, n=97) or transapical (TA-) TAVR (n=66) between February 2009 and December 2012. Clinical endpoints were categorized according to VARC-2 definitions and in-hospital costs were determined from the hospital perspective. Finally, the additional costs of complications were estimated using multiple linear regression models. TF-TAVR patients experienced significantly more minor access site bleeding, major non-access site bleeding, minor vascular complications, stage 2 acute kidney injury (AKI) and permanent pacemaker implantation. Total in-hospital costs did not differ between groups and were on average €40,348 (SD 15,851) per patient. The average incremental cost component of a single complication was €3438 (p<0.01) and the estimated cost of a TF-TAVR without complications was €34,351. The complications associated with the highest additional costs were life-threatening non-access site bleeding (€47,494; p<0.05), stage 3 AKI (€20,468; p<0.01), implantation of a second valve (€16,767; p<0.01) and other severe cardiac dysrhythmia (€10,611 p<0.05). Overall, the presence of complication-related in-hospital mortality increased costs. Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers in our TAVR patients. Strategies and advances in device design aimed at reducing these complications have the potential to generate significant in-hospital cost reductions for the German Health Care System. Copyright © 2014. Published by Elsevier Ireland Ltd.

Occult gastrointestinal bleeding is a common finding in dogs with chronic kidney disease.

PubMed

Crivellenti, Leandro Z; Borin-Crivellenti, Sofia; Fertal, Kristi L; Contin, Catarina M; Miranda, Caroline M J; Santana, Aureo E

2017-03-01

The risk of occult gastrointestinal bleeding (OGIB) is known to be increased among human dialysis patients suffering from end-stage renal disease. However, there are no studies to date that investigate the incidence of OGIB in either dogs or people with chronic kidney disease (CKD), irrespective of dialysis. The purpose of the study was to determine whether the incidence of OGIB is greater in dogs with CKD as compared to a control population, and if this pathology is associated with changes in serum variables related to iron metabolism. Fecal occult bleeding was evaluated in 10 healthy dogs and 30 CKD dogs. Test results were compared to indicators of blood loss and/or iron metabolism. Dogs with CKD had a significantly higher incidence of OGIB than the control group (P < .0001). While 80% of dogs with stage 2 CKD did not exhibit anemia, 90% tested positive for OGIB. Similarly, subjects with stage 4 CKD had more significant blood loss than either stage 2 (P = .0071) or stage 3 CKD (P = .0385). Serum hemoglobin, transferrin, and iron concentrations in the CKD group were statistically lower than in the control group (P < .0001) and correlated with fecal occult bleeding (r = -.61; r = -.40; r = -.44, respectively), as well as serum creatinine concentrations (P < .0001, r = .64). This preliminary study suggests that OGIB is a common clinical finding among dogs with CKD, even in the early stages of the disease process. Therefore, fecal occult blood tests may be useful as an indication for gastroprotective agents in the treatment plan. © 2017 American Society for Veterinary Clinical Pathology.

Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease.

PubMed

Shelygin, Yuri; Krivokapic, Zoran; Frolov, S A; Kostarev, I V; Astashov, V L; Vasiliev, S V; Lakhin, A V; Rodoman, G V; Soloviev, A O; Stoyko, Y M; Khitaryan, A G; Nechay, I A

2016-11-01

To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids. MPFF is an established treatment for hemorrhoidal disease. This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively). Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); -2.37 cm MPFF 1000 mg (P < 0.001) and -2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction -2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg. After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets. Key limitations: Safety study.

Correlation Between Findings of Multislice Helical Computed Tomography (CT), Endoscopic Examinations, Endovascular Procedures, and Surgery in Patients with Symptoms of Acute Gastrointestinal Bleeding

PubMed Central

Konecki, Dariusz; Pacho, Ryszard; Rowiński, Olgierd

2017-01-01

Summary Background Endoscopic methods (gastroscopy and colonoscopy) are considered fundamental for the diagnosis of gastrointestinal bleeding. In recent years, multidetector computed tomography (MDCT) has also gained importance in diagnosing gastrointestinal bleeding, particularly in hemodynamically unstable patients and in cases with suspected lower gastrointestinal tract bleeding. CT can detect both the source and the cause of active gastrointestinal bleeding, thereby expediting treatment initiation. Material/Methods The study group consisted of 16 patients with clinical symptoms of gastrointestinal bleeding in whom features of active bleeding were observed on CT. In all patients, bleeding was verified by means of other methods such as endoscopic examinations, endovascular procedures, or surgery. Results The bleeding source was identified on CT in all 16 patients. In 14 cases (87.5%), bleeding was confirmed by other methods. Conclusions CT is an efficient, fast, and readily available tool for detecting the location of acute gastrointestinal bleeding. PMID:29662594

Oral Surgical Treatment of Patients With Chronic Liver Disease: Assessments of Bleeding and Its Relationship With Thrombocytopenia and Blood Coagulation Parameters.

PubMed

Cocero, Nadia; Bezzi, Marta; Martini, Silvia; Carossa, Stefano

2017-01-01

Cirrhotic patients awaiting liver transplantation require eradication of infectious oral foci to prevent septic episodes after transplantation; however, cirrhosis can hinder hemostasis and can result in severe bleeding. The present study assessed the bleeding risk factors connected with the clinical history of these patients and the characteristics of the extractions. We retrospectively analyzed 1183 extractions in 318 patients, including 47 with severe end-stage liver disease who were outside of our intention-to-treat bracket (ie, platelet count [PLT] >40 × 10 3 /μL and international normalized ratio [INR] <2.5). Follow-up examinations included inspection of the oral cavity on the first, third, and seventh days, with reparatory surgery in the case of severe bleeding. Continuous variables were compared using the Mann-Whitney U and Kruskal-Wallis tests, and categorical variables were compared using Fisher's exact test. Binary logistic regression analysis was also performed. Within the intention-to-treat bracket, 1 of the 271 patients (0.4%) required surgical repair. The bleeding rate for an INR of 2.5 or more was significantly greater than that for a PLT of 40 × 10 3 /μL or less (4 of 10 [40%] versus 2 of 34 [6%]; P = .02]. All 3 patients with both an INR of 2.5 or more and a PLT of 40 × 10 3 /μL or less exhibited severe bleeding. No significant association between the occurrence of bleeding with either liver disease etiology or the number of molars extracted was found. No patient required hospitalization. Patients with a PLT greater than 40 × 10 3 /μL and an INR of less than 2.5 can be considered relatively low-risk patients. However, an INR of 2.5 or more and, to a minor degree, a PLT of 40 × 10 3 /μL or less represent significant risk factors. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

A randomised clinical study to evaluate the efficacy of alcohol-free or alcohol-containing mouthrinses with chlorhexidine on gingival bleeding

PubMed Central

Jose, A.; Butler, A.; Payne, D.; Maclure, R.; Rimmer, P.; Bosma, M. L.

2015-01-01

Objectives Gingival bleeding following twice-daily use of 0.2% w/v chlorhexidine digluconate mouthrinse with and without alcohol (0.2% CHX-alcohol; 0.2% CHX-alcohol-free, respectively) and brushing with a standard fluoride toothpaste was compared to brushing alone. Methods Three hundred and nineteen subjects with mild-to-moderate gingivitis (with ≥16 gradable permanent teeth including four molars, bleeding after brushing and ≥20 bleeding sites) completed this randomised, examiner-blinded, parallel-group study. A prophylaxis was performed at baseline. Gingival Severity Index (GSI; primary objective), Gingival Index (GI) and Plaque Index (PI) were assessed at baseline and after 6 weeks of treatment. Adverse events (AEs) were recorded throughout the study. Results Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (primary endpoint; treatment difference −0.061 [95% CI −0.081, −0.041] and −0.070 [95% CI −0.090, −0.050], respectively; both p <0.0001). There were also significant reductions in GI and PI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (all p <0.0001). The proportion of subjects reporting ≥1 treatment-related adverse events (TRAEs) was 27.8% (0.2% CHX-alcohol), 24.8% (0.2% CHX-alcohol-free) and 3.7% (brushing alone). Conclusions Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores, plaque and gingival inflammation compared to brushing alone. TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses. PMID:26271869

Congenital portosystemic shunts with and without gastrointestinal bleeding - case series.

PubMed

Gong, Ying; Zhu, Hui; Chen, Jun; Chen, Qi; Ji, Min; Pa, Mier; Zheng, Shan; Qiao, Zhongwei

2015-12-01

The clinical presentation of congenital portosystemic shunt is variable and gastrointestinal bleeding is an uncommon presentation. To describe the imaging features of congenital portosystemic shunt as it presented in 11 children with (n = 6) and without gastrointestinal bleeding (n = 5). We performed a retrospective study on a clinical and imaging dataset of 11 children diagnosed with congenital portosystemic shunt. A total of 11 children with congenital portosystemic shunt were included in this study, 7 with extrahepatic portosystemic shunts and 4 with intrahepatic portosystemic shunts. Six patients with gastrointestinal bleeding had an extrahepatic portosystemic shunt, and the imaging results showed that the shunts originated from the splenomesenteric junction (n = 5) or splenic vein (n = 1) and connected to the internal iliac vein. Among the five cases of congenital portosystemic shunt without gastrointestinal bleeding, one case was an extrahepatic portosystemic shunt and the other four were intrahepatic portosystemic shunts. Most congenital portosystemic shunt patients with gastrointestinal bleeding had a shunt that drained portal blood into the iliac vein via an inferior mesenteric vein. This type of shunt was uncommon, but the concomitant rate of gastrointestinal bleeding with this type of shunt was high.

Periodontal disease in a remote Asian population: association between clinical and microbiological parameters.

PubMed

Kvarnvik, Christine; Söljegård, Emelie; Charalampakis, Georgios; Suksu-Art, Narong; Dahlén, Gunnar

2016-08-01

The aim was to clinically and microbiologically describe the periodontal conditions in a remote adult Asian population with poor oral hygiene. The subjects were 30-60-year-old adults of Karen Hill tribes with no access to dental care. Eighty-six subjects were selected randomly. Clinical registrations included number of remaining teeth, plaque index (PlI), bleeding on probing (BoP), clinical attachment loss (CAL), and probing pocket depth (PPD). Subgingival plaque samples were collected and analyzed with the checkerboard method. Subjects of the study group had mean number of remaining teeth of 26.5 despite the abundant plaque and a high bleeding score. Severe periodontitis (CAL ≥ 7 mm) was recorded in 12.9% of the youngest age group (30-39 years) while it was significantly higher (52%) in the middle group (40-49 years) and (60%) in the eldest age group (50-60 years). Pathological pocketing (PPD ≥ 7 mm) was significantly lower in all age groups. Age, betel chewing, and a microbiological cluster including at least one of Prevotella tannerae, Filifactor alocis and Porphyromonas endodontalis significantly correlated with the severity of periodontal disease. Age, betel chewing, and a new bacterial complex other than the "red complex" correlated to periodontal breakdown in this remote adult Asian population. © 2015 Wiley Publishing Asia Pty Ltd.

Should a prolonged duration of dual anti-platelet therapy be recommended to patients with diabetes mellitus following percutaneous coronary intervention? A systematic review and meta-analysis of 15 studies.

PubMed

Bundhun, Pravesh Kumar; Yanamala, Chandra Mouli; Huang, Feng

2016-08-30

This study aimed to compare the adverse clinical outcomes associated with a short and a prolonged duration of Dual Anti-Platelet Therapy (DAPT) in patients with Diabetes Mellitus (DM) after undergoing Percutaneous Coronary Intervention (PCI). Medline/PubMed, EMBASE and the Cochrane library were searched for studies comparing the short and prolonged DAPT use in patients with DM. Adverse outcomes were considered as the clinical endpoints in this analysis. Odds Ratios (OR) with 95 % Confidence Intervals (CI) were used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. Fifteen studies with a total number of 25,742 patients with DM were included in this current analysis which showed no significant differences in primary endpoints, net clinical outcomes, myocardial infarction and stroke with OR: 1.03, 95 % CI: 0.65-1.64; P = 0.90, OR: 0.96, 95 % CI: 0.69-1.34; P = 0.81, OR: 0.85, 95 % CI: 0.70-1.04; P = 0.12 and OR: 0.94, 95 % CI: 0.65-1.36; P = 0.75 respectively. Revascularization was also similar between these 2 groups of patients with DM. However, even if mortality favored prolonged DAPT use, with OR: 0.87, 95 % CI: 0.76-1.00; P = 0.05, the result only approached significance. Also, stent thrombosis insignificantly favored a prolonged DAPT duration with OR: 0.56, 95 % CI: 0.27-1.17; P = 0.12. Thrombolysis In Myocardial Infarction (TIMI) defined major and minor bleeding were not significantly different in these diabetic patients with OR: 0.91, 95 % CI: 0.60-1.37; P = 0.65 and OR: 1.08, 95 % CI: 0.62-1.91; P = 0.78 respectively. However, bleeding defined by the Bleeding Academic Research Consortium (BARC) classification was significantly higher with a prolonged DAPT use in these diabetic patients with OR: 1.92, 95 % CI: 1.58-2.34; P < 0.00001. Following PCI, a prolonged DAPT use was associated with similar adverse clinical outcomes but with a significantly increased BARC defined bleeding compared to a short term DAPT use in these patients with DM. However, even if mortality and stent thrombosis favored a prolonged DAPT use, these outcomes only either reached statistical significance or were insignificant respectively, showing that a clear decision about recommending a prolonged duration of DAPT to patients with DM might not be possible at this moment, warranting further research in this particular subgroup.

Self-Expandable Metal Stents for Persisting Esophageal Variceal Bleeding after Band Ligation or Injection-Therapy: A Retrospective Study.

PubMed

Müller, Martin; Seufferlein, Thomas; Perkhofer, Lukas; Wagner, Martin; Kleger, Alexander

2015-01-01

Despite a pronounced reduction of lethality rates due to upper gastrointestinal bleeding, esophageal variceal bleeding remains a challenge for the endoscopist and still accounts for a mortality rate of up to 40% within the first 6 weeks. A relevant proportion of patients with esophageal variceal bleeding remains refractory to standard therapy, thus making a call for additional tools to achieve hemostasis. Self-expandable metal stents (SEMS) incorporate such a tool. We evaluated a total number of 582 patients admitted to our endoscopy unit with the diagnosis "gastrointestinal bleeding" according to our documentation software between 2011 and 2014. 82 patients suffered from esophageal variceal bleeding, out of which 11 cases were refractory to standard therapy leading to SEMS application. Patients with esophageal malignancy, fistula, or stricture and a non-esophageal variceal bleeding source were excluded from the analysis. A retrospective analysis reporting a series of clinically relevant parameters in combination with bleeding control rates and adverse events was performed. The initial bleeding control rate after SEMS application was 100%. Despite this success, we observed a 27% mortality rate within the first 42 days. All of these patients died due to non-directly hemorrhage-associated reasons. The majority of patients exhibited an extensive demand of medical care with prolonged hospital stay. Common complications were hepatic decompensation, pulmonary infection and decline of renal function. Interestingly, we found in 7 out of 11 patients (63.6%) stent dislocation at time of control endoscopy 24 h after hemostasis or at time of stent removal. The presence of hiatal hernia did not affect obviously stent dislocation rates. Refractory patients had significantly longer hospitalization times compared to non-refractory patients. Self-expandable metal stents for esophageal variceal bleeding seem to be safe and efficient after failed standard therapy. Stent migration appeared to be a common incident that did not lead to reactivation of bleeding in any of our patients. SEMS should be considered a reasonable treatment option for refractory esophageal variceal bleeding after treatment failure of ligature and sclerotherapy and non-availability of or contraindication for other measures (e.g. TIPS).

Gene polymorphisms and the risk of warfarin-induced bleeding complications at therapeutic international normalized ratio (INR)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pourgholi, Leyla

Background: Bleeding episodes commonly occur in patients on warfarin treatment even in those within therapeutic range of international normalized ratio (INR). The objective of this study was to investigate the effects of the 8 examined polymorphisms on the risk of bleeding complications in a sample of Iranian patients. Methods: A total of 552 warfarin treated patients who maintained on a target INR level of 2.0–3.5 for at least three consecutive intervals were enrolled from those attended our anticoagulation clinics. Ninety-two bleeding events were observed in 87 patients. The presences of the examined polymorphisms were analyzed using polymerase chain reaction-based restrictionmore » fragment length polymorphism (PCR-RFLP). Results: Patients with the T allele in NQO1*2 (CT or TT genotypes) had a higher risk of bleeding than patients with the CC genotype (adjusted OR: 2.25, 95% CI: 1.37 to 3.70, P = 0.001). Those who were carriers of CYP2C9 one-variant haplotypes (*1/*2 or *1/*3) were also found to be associated with the higher risk of bleeding events. Compared to reference group (*1/*1), the odds of bleeding increased for carriers of one variant allele (*1/*2 or *1/*3) (adjusted OR: 1.75, 95% CI: 1.03 to 2.97, P = 0.039). Variant VKORC1, Factor VII, and EPHX1 genotypes were not significantly associated with the risk of bleeding events. Conclusion: The SNP C609T within NQO1 and haplotypes of CYP2C9 (1*2 or 1*3) are independently associated to bleeding complications of warfarin at normal INR. Further studies are required to confirm such associations in diverse racial and ethnic populations. - Highlights: • NQO1 C609T variant is associated with warfarin induced bleeding at therapeutic INR. • Haplotypes of CYP2C9 (1*2 or 1*3) are also associated with bleeding events. • VKORC1, Factor VII, and EPHX1 genotypes were not associated with bleeding risk.« less

Incidence of Gastrointestinal Bleeding After Percutaneous Coronary Intervention: A Single Center Experience.

PubMed

Aziz, Fahad

2014-02-01

Gastrointestinal (GI) bleeding is a hemorrhagic complication after percutaneous coronary intervention in patients with acute myocardial infarction. The purpose of the study is to determine predictors of GI bleeding and impact of GI bleeding on the patients undergoing percutaneous coronary intervention. GI bleeding occurred in 6 (7.1%) of 84 patients with STEMI/NSETMI (ST-segment elevated myocardial infarction/Non ST-segment elevated myocardial infarction) undergoing primary percutaneous coronary intervention. Univariate analysis demonstrates that patients with GI bleeding had a significantly higher previous GI bleeding (16.66% vs. 8.6%, P < 0.001). Higher Killip classification at presentation was associated with higher incidence of GI bleeding (61% vs. 18%, P < 0.01). The use of proton pump inhibitors did not reduce the risk of GI bleeding. The GI bleeding in these patients was associated with higher mortality and morbidity in the post percutaneous coronary intervention period. Although, GI bleeding in patients with MI significantly increases mortality and morbidity, previous GI bleeding and higher Killip class are associated with higher incidence of GI bleeding. High-risk patients for GI bleeding can be identified at presentation.

Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in "real-world" clinical practice. A propensity-matched analysis of 76,940 patients.

PubMed

Li, Xiaoyan Shawn; Deitelzweig, Steve; Keshishian, Allison; Hamilton, Melissa; Horblyuk, Ruslan; Gupta, Kiran; Luo, Xuemei; Mardekian, Jack; Friend, Keith; Nadkarni, Anagha; Pan, Xianying; Lip, Gregory Y H

2017-06-02

The ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA 2 DS 2 -VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59-0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54-0.65) than warfarin initiators. Different types of stroke/SE and major bleeding - including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding - were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA 2 DS 2 -VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest "real-world" study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard- and low-dose apixaban dose regimens.

Gastrointestinal Bleeding in Athletes.

PubMed

Eichner, E R

1989-05-01

In brief: Gastrointestinal (GI) bleeding is a troubling yet intriguing complication of distance running. This clinical overview traces our evolving understanding of the scope and importance of GI bleeding in runners and other athletes, and discusses the diverse causes, sites, and implications of exercise-related GI bleeding. It concludes with practical tips to prevent or mitigate this problem, including gradual conditioning, avoidance of prerace aspirin intake, and when indicated, therapy with antacids, H2 blockers, or iron.

PubMed Central

Baillargeon, L.; Drouin, J.; Desjardins, L.; Leroux, D.; Audet, D.

1993-01-01

The purpose of this study, which took the form of a two-period cross-over clinical trial, was to determine whether a homeopathic substance, Arnica Montana, significantly decreased bleeding time (Simplate II) and to describe its impact on various blood coagulation tests. It was not shown that this substance had a significant impact on various parameters of blood coagulation in healthy volunteers in the period immediately following administration [corrected]. PMID:7903572

[Gastrointestinal hemorrhage caused by esophageal varix rupture].

PubMed

Konate, A; Diarra, M T; Souckho, A; Katilé, I; Soumaré, G; Kallé, A; Traoré, H A; Maiga, M Y

2008-01-01

The aim of this study was to analyze digestive hemorrhage by oesophageal varicose vein bleeding, were pharmacological and endoscopic treatments suitable are not available. This prospective study related to 50 patients admitted for oesophageal varicose vein bleeding in the service of hepato-gastro-enterology of the hospital Gabriel Touré (MALI), from June 2003 to December 2005. The patients underwent clinical examination and upper digestive endoscopy to appreciate oesophageal varicose vein and marks of bleeding. Some biological examinations (haemoglobin, hematocrit, prothrombin time) were carried out in emergency to appreciate systemic repercussion of the haemorrhage. Our results showed that by oesophageal varicose vein bleeding represented 2.5% of the hospitalizations during the period of study.The average age of the patients was 37 years with, a sex ratio of 6.1% in favour of men. Antecedent of jaundice was frequently found (54%). The main cause of the varicose vein was cirrhosis. Mortality was 48%. The prognosis was not significantly improved by blood transfusion. At the end of this study, the stress must be laid on the HBV prevention because HBV is the main cause of chronic liver diseases.

Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study

PubMed Central

Roshanov, Pavel S.; Eikelboom, John W.; Crowther, Mark; Tandon, Vikas; Borges, Flavia K.; Kearon, Clive; Lamy, Andre; Whitlock, Richard; Biccard, Bruce M.; Szczeklik, Wojciech; Guyatt, Gordon H.; Panju, Mohamed; Spence, Jessica; Garg, Amit X.; McGillion, Michael; VanHelder, Tomas; Kavsak, Peter A.; de Beer, Justin; Winemaker, Mitchell; Sessler, Daniel I.; Le Manach, Yannick; Sheth, Tej; Pinthus, Jehonathan H.; Thabane, Lehana; Simunovic, Marko R.I.; Mizera, Ryszard; Ribas, Sebastian; Devereaux, P.J.

2017-01-01

Introduction: Various definitions of bleeding have been used in perioperative studies without systematic assessment of the diagnostic criteria for their independent association with outcomes important to patients. Our proposed definition of bleeding impacting mortality after noncardiac surgery (BIMS) is bleeding that is independently associated with death during or within 30 days after noncardiac surgery. We describe our analysis plan to sequentially 1) establish the diagnostic criteria for BIMS, 2) estimate the independent contribution of BIMS to 30-day mortality and 3) develop and internally validate a clinical prediction guide to estimate patient-specific risk of BIMS. Methods: In the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) study, we prospectively collected bleeding data for 16 079 patients aged 45 years or more who had noncardiac inpatient surgery between 2007 and 2011 at 12 centres in 8 countries across 5 continents. We will include bleeding features independently associated with 30-day mortality in the diagnostic criteria for BIMS. Candidate features will include the need for reoperation due to bleeding, the number of units of erythrocytes transfused, the lowest postoperative hemoglobin concentration, and the absolute and relative decrements in hemoglobin concentration from the preoperative value. We will then estimate the incidence of BIMS and its independent association with 30-day mortality. Last, we will construct and internally validate a clinical prediction guide for BIMS. Interpretation: This study will address an important gap in our knowledge about perioperative bleeding, with implications for the 200 million patients who undergo noncardiac surgery globally every year. Trial registration: ClinicalTrials.gov, no NCT00512109. PMID:28943515

Effect of carprofen on hemostatic variables in dogs.

PubMed

Hickford, F H; Barr, S C; Erb, H N

2001-10-01

To evaluate the effect of carprofen on hemostatic variables in clinically normal dogs. 12 clinically normal Labrador Retrievers. 10 dogs (6 females, 4 males) received carprofen (2.2 mg/kg of body weight, PO, q 12 h) for 5 days. Two dogs (untreated control group; 1 female, 1 male) did not receive carprofen. Hemostatic variables (platelet count, activated partial thromboplastin time, prothrombin time, fibrinogen, platelet aggregation, and bleeding time) were assessed for all dogs prior to treatment, on day 5 of treatment, and 2 and 7 days after discontinuation of the drug (days 7 and 12). Serum biochemical variables and Hct were assessed prior to treatment and on days 5 and 12. In dogs receiving carprofen, platelet aggregation was significantly decreased, and onset of aggregation was significantly delayed on days 5, 7, and 12, compared with pretreatment values. Activated partial thromboplastin time was significantly increased on days 5, 7, and 12 over pretreatment values in treated dogs, but values remained within reference ranges. Significant differences were not detected in buccal mucosal bleeding time, other serum biochemical and hemostatic variables, or Hct, compared with pretreatment values and the internal control group. Administration of carprofen for 5 days causes minor but not clinically important alterations in hemostatic and serum biochemical variables in clinically normal Labrador Retrievers. Carprofen is commonly used to treat osteoarthritis and chronic pain in dogs, but prior to this study, its effect on platelet aggregation and hemostatic variables was unknown.

Effectiveness of adjunctive subgingival administration of amino acids and sodium hyaluronate gel on clinical and immunological parameters in the treatment of chronic periodontitis

PubMed Central

Bevilacqua, Lorenzo; Eriani, Jessica; Serroni, Ilde; Liani, Giuliana; Borelli, Violetta; Castronovo, Gaetano; Di Lenarda, Roberto

2012-01-01

Summary Aims The aim of this clinical trial was to compare clinical and biochemical healing outcomes following ultrasonic mechanical instrumentation versus ultrasonic mechanical instrumentation associated with topical subgingival application of amino acids and sodium hyaluronate gel. Methods Eleven systemically healthy subjects with moderate-severe chronic periodontitis, who had four sites with pocket probing depth and clinical attachment level greater than or equal to 5 mm were randomly assigned to two different types of treatment: two pockets were treated with ultrasonic debridement (Control Group) and two pockets with ultrasonic mechanical instrumentation associated with 0,5 ml of amino acids and sodium hyaluronate gel (Test Group). Probing depth, clinical attachment level, plaque index and bleeding on probing were recorded at baseline, 45 and 90 days. Levels of calprotectin and myeloperoxidase activity in gingival crevicular fluid were assessed at baseline and on day 7 and 45. Results Statistical significance was found between baseline and day 45 in relation to probing depth reduction and bleeding on probing between groups for both of the tested treatments. Significant reductions in μg/sample of calprotectin and myeloperoxidase were found after 1-week and an increase at 45 days in both groups. There were no statistically significant differences between other variables evaluated in this study. Conclusions These data suggest that subgingival application of hyaluronic acid following ultrasonic mechanical instrumentation is beneficial for improving periodontal parameters. PMID:23087790

Consequences of bleeding after thyroid surgery – analysis of 7805 operations performed in a single center

PubMed Central

Aporowicz, Michał; Kaliszewski, Krzysztof; Bolanowski, Marek

2016-01-01

Introduction Surgical treatment of thyroid gland diseases is associated with the possibility of severe complications. The most dangerous of them is bleeding. Current studies focus on its risk factors, rather than reoperation-related consequences. Material and methods We analyzed 7805 thyroid operations performed from 1996 to 2014 in the Clinic of General, Gastroenterological and Endocrine Surgery of Wroclaw Medical University. Typical risk factors, symptoms and consequences of bleeding were analyzed. Results Among operated patients 88.2% were female and 11.8% male. Bleeding occurred in 84 (1.08%) patients. Sex (p = 0.006), preoperative thyroid pathology (p = 0.03), and type of operation (p < 0.001) are significant risk factors for bleeding, while retrosternal goiter and surgeon’s experience are not. Risk of bleeding is highest in the case of male sex, toxic goiter and total resection of the thyroid gland. Most reoperations took place within 6 h. In 88.8% of cases of this kind of complication the surgeon indicated the exact source of bleeding; most commonly it was the neck muscles, skin and subcutaneous tissue, or the thyroid stump. Three patients required a second reoperation, 24 suffered further complications, and 8 required transfer to the Intensive Care Unit (ICU). Cardiac arrest occurred in 3 patients and 2 suffered bilateral vocal cord palsy. Conclusions Bleeding after thyroid operations is a direct life threat that requires immediate intervention. As a result death may occur, half of patients suffer other complications and some require intensive care. The risk is highest in the case of male sex, toxic goiter and total resection of the thyroid gland. Each patient after thyroid surgery needs to be closely observed. An operating theatre and ICU should be available at all times. PMID:29593806

Is the AIMS65 score useful in predicting outcomes in peptic ulcer bleeding?

PubMed

Jung, Sung Hoon; Oh, Jung Hwan; Lee, Hye Yeon; Jeong, Joon Won; Go, Se Eun; You, Chan Ran; Jeon, Eun Jung; Choi, Sang Wook

2014-02-21

To evaluate the applicability of AIMS65 scores in predicting outcomes of peptic ulcer bleeding. This was a retrospective study in a single center between January 2006 and December 2011. We enrolled 522 patients with upper gastrointestinal haemorrhage who visited the emergency room. High-risk patients were regarded as those who had re-bleeding within 30 d from the first endoscopy as well as those who died within 30 d of visiting the Emergency room. A total of 149 patients with peptic ulcer bleeding were analysed, and the AIMS65 score was used to retrospectively predict the high-risk patients. A total of 149 patients with peptic ulcer bleeding were analysed. The poor outcome group comprised 28 patients [male: 23 (82.1%) vs female: 5 (10.7%)] while the good outcome group included 121 patients [male: 93 (76.9%) vs female: 28 (23.1%)]. The mean age in each group was not significantly different. The mean serum albumin levels in the poor outcome group were slightly lower than those in the good outcome group (P = 0.072). For the prediction of poor outcome, the AIMS65 score had a sensitivity of 35.5% (95%CI: 27.0-44.8) and a specificity of 82.1% (95%CI: 63.1-93.9) at a score of 0. The AIMS65 score was insufficient for predicting outcomes in peptic ulcer bleeding (area under curve = 0.571; 95%CI: 0.49-0.65). The AIMS65 score may therefore not be suitable for predicting clinical outcomes in peptic ulcer bleeding. Low albumin levels may be a risk factor associated with high mortality in peptic ulcer bleeding.

Abrogating fibrinolysis does not improve bleeding or rFVIIa/rFVIII treatment in a non-mucosal venous injury model in haemophilic rodents.

PubMed

Stagaard, Rikke; Flick, Matthew J; Bojko, Barbara; Goryński, Krzysztof; Goryńska, Paulina Z; Ley, Carsten D; Olsen, Lisbeth H; Knudsen, Tom

2018-05-14

Fibrinolysis may exacerbate bleeding in haemophilia A (HA). Accordingly, antifibrinolytics have been used to help maintain haemostatic control. While antifibrinolytic drugs have been proven effective in the treatment of mucosal bleeds in the oral cavity, their efficacy in non-mucosal tissues remain an open question of significant clinical interest. To determine whether inhibiting fibrinolysis improves the outcome in non-mucosal haemophilic tail vein transection (TVT) bleeding models, and to determine whether a standard ex vivo clotting/fibrinolysis assay can be used as a predictive surrogate for in vivo efficacy. A highly sensitive tail vein transection model was employed in haemophilic rodents with a suppressed fibrinolytic system to examine the effect of inhibiting fibrinolysis on bleeding in a non-mucosal tissue. In mice induced- and congenital haemophilia models were combined with fibrinolytic attenuation achieved either genetically or pharmacologically (tranexamic acid; TXA) induced. In haemophilic rats, tail bleeding was followed by whole blood rotational thromboelastometry (ROTEM) evaluation of the same animals to gauge the predictive value of such assays. The beneficial effect of systemic TXA therapy observed ex vivo could not be confirmed in vivo in haemophilic rats. Furthermore, neither intravenously administered TXA nor congenital knockout of the fibrinolytic genes plasminogen or tissue-type plasminogen activator markedly improved the TVT bleeding phenotype or response to factor therapy in haemophilic mice. The finding here suggest that inhibition of fibrinolysis is not effective in limiting the TVT bleeding phenotype of haemophilia A rodents in non-mucosal tissues. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Effect of nabumetone and aspirin on colonic mucosal bleeding time.

PubMed

Basson, M D; Panzini, L; Palmer, R H

2001-04-01

The management of patients taking aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) who require colonoscopy remains controversial because of concerns over bleeding after biopsy or polypectomy. To determine whether patients using the NSAID nabumetone, a non-acidic prodrug with mixed activity against cyclooxygenase-1 (COX-1) and COX-2, exhibited prolonged mucosal bleeding times and how this might compare with mucosal bleeding times in patients using aspirin. We assessed triplicate mucosal bleeding times in patients undergoing screening flexible sigmoidoscopy. We compared 90 patients who had taken no aspirin or NSAIDs within the previous 2 weeks, to 60 patients who had received nabumetone 1 g b.d. by mouth for the previous 2 weeks, and 30 patients who had taken 325 mg aspirin daily for the previous 2 weeks. In each case, the investigator performing the study was blinded to the patient's medication. Mucosal bleeding times did not differ significantly among control or nabumetone-using patients. However, the patients receiving aspirin exhibited significant prolongation. Mucosal bleeding time correlated statistically significantly, but weakly, with skin bleeding time. Nabumetone does not appear to prolong mucosal bleeding time after mucosal pinch biopsy, and skin bleeding time does not reliably screen for prolonged mucosal bleeding time.

Current limitations of the assessment of haemostasis in adult extracorporeal membrane oxygenation patients and the role of point-of-care testing.

PubMed

Venkatesh, K; Nair, P S; Hoechter, D J; Buscher, H

2016-11-01

Haemostatic perturbations are commonly seen in extracorporeal membrane oxygenation (ECMO) patients and remain a clinical challenge, contributing significantly to morbidity and mortality. The approach to anticoagulation monitoring and the management of bleeding varies considerably across ECMO centres. Routine laboratory tests have their limitations in terms of turnaround time and specificity of information provided. Newer point-of-care testing (POCT) for coagulation may overcome these issues, as it provides information about the entire coagulation pathway from clot initiation to lysis. It is also possible to obtain qualitative information on platelet function from these tests. Furthermore, the ability to incorporate these results into a goal-directed algorithm to manage bleeding with targeted transfusion strategies appears particularly attractive and cost effective. Further studies are required to evaluate the utility of POCT to optimise bleeding and anticoagulation management in these complex patients.

Clinical experience with fibrin glue in cardiac surgery.

PubMed

Köveker, G; de Vivie, E R; Hellberg, K D

1981-10-01

Cardiac surgery is often associated with hemostatic abnormalities leading to severe bleeding. Special problems are to be expected, if prosthetic material has to be implanted. Preclotting of Dacron prostheses with blood is well established but failures are sometimes encountered. Several years ago a new hemostatic sealing system (fibrin glue) was introduced into therapy. Since 1978 fibrin glue has been applied in 176 patients. The indications were: 1. sealing of woven Dacron prostheses, 2. bleeding from suture-holes (Gore-Tex), 3. diffuse myocardial bleeding and 4. prevention of kinking of coronary artery grafts. In 32 patients with an aortoventriculoplasty operation using Dacron the "blood preclotting" and "fibrin sealing" methods were compared. In the fibrin glue group there was a significant reduction in postoperative blood loss as well as a shortening of the operation time (period of protamin administration to skin closure). No fibrinolytic dissolution of the fibrin layer on the prostheses was observed.

Antiplatelet therapy in PCI

PubMed Central

Fanaroff, Alexander; Rao, Sunil

2018-01-01

Platelets play a key role in mediating stent thrombosis, the major cause of ischemic events in the immediate period following percutaneous coronary intervention (PCI). For this reason, antiplatelet therapy, started at the time of PCI and continued for at least 30 days afterwards, is the cornerstone of antithrombotic therapy after PCI. However, the use of antiplatelet agents increase bleeding risk, with more potent antiplatelet agents further increasing bleeding risk. For this reason, balancing prevention of ischemic events with risk of bleeding is fundamental to the effective use of antiplatelet agents. In the past 5 years, potent and fast-acting P2Y12 inhibitors have been introduced, and have augmented the antiplatelet armamentarium available to interventional cardiologists. In this review, we review the preclinical and clinical data surrounding these new agents, and discuss the significant questions and controversies that still exist regarding the optimal antiplatelet strategy. PMID:28582206

Usefulness of the comprehensive geriatric assessment in older patients with upper gastrointestinal bleeding: a two-year follow-up study.

PubMed

Pilotto, Alberto; Ferrucci, Luigi; Scarcelli, Carlo; Niro, Valeria; Di Mario, Francesco; Seripa, Davide; Andriulli, Angelo; Leandro, Gioacchino; Franceschi, Marilisa

2007-01-01

The potential usefulness of standardized comprehensive geriatric assessment (CGA) in evaluating treatment and follow-up of older patients with upper gastrointestinal bleeding is unknown. To evaluate the usefulness of the CGA as a 2-year mortality multidimensional prognostic index (MPI) in older patients hospitalized for upper gastrointestinal bleeding. Patients aged > or =65 years consecutively hospitalized for acute upper gastrointestinal bleeding were included. Diagnosis of bleeding was based on clinical and endoscopic features. All patients underwent a CGA that included six standardized scales, i.e., Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Short Portable Mental Status Questionnaire (SPMSQ), Mini Nutritional Assessment (MNA), Exton-Smith Score (ESS) and Comorbity Index Rating Scale (CIRS), as well as information on medication history and cohabitation, for a total of 63 items. A MPI was calculated from the integrated total scores and expressed as MPI 1 = low risk, MPI 2 = moderate risk, and MPI 3 = severe risk. The predictive value of the MPI for mortality over a 24-month follow-up was calculated. 36 elderly patients (M 16/F 20, mean age 82.8 +/- 7.9 years, range 70-101 years) were included in the study. A significant difference in mean age was observed between males and females (M 80.1 +/- 4.8 vs. F 84.9 +/- 9.3 years; p < 0.05). The causes of upper gastrointestinal bleeding were duodenal ulcer in 38.8%, gastric ulcer in 22.2%, and erosive gastritis in 16.6% of the patients, while 16.6% had gastrointestinal bleeding from unknown origin. The overall 2-year mortality rate was 30.5%. 18 patients (50%) were classified as having a low-risk MPI (mean value 0.18 +/- 0.09), 12 (33.3%) as having a moderate-risk MPI (mean value 0.48 +/- 0.08) and 6 (16.6%) as having a severe-risk MPI (mean value 0.83 +/- 0.06). Higher MPI grades were significantly associated with higher mortality (grade 1 = 12.5%, grade 2 = 41.6%, grade 3 = 83.3%; p = 0.001). Adjusting for age and sex, the prognostic efficacy of MPI for mortality was confirmed and highly significant (odds ratio 10.47, 95% CI 2.04-53.6). CGA is a useful tool for calculating a MPI that significantly predicts the risk of 2-year mortality in older patients with upper gastrointestinal bleeding. Copyright 2007 S. Karger AG, Basel.

Investigation of Women with Postmenopausal Uterine Bleeding: Clinical Practice Recommendations

PubMed Central

Munro, Malcolm G

2014-01-01

Postmenopausal uterine bleeding is defined as uterine bleeding after permanent cessation of menstruation resulting from loss of ovarian follicular activity. Bleeding can be spontaneous or related to ovarian hormone replacement therapy or to use of selective estrogen receptor modulators (eg, tamoxifen adjuvant therapy for breast carcinoma). Because anovulatory “cycles” with episodes of multimonth amenorrhea frequently precede menopause, no consensus exists regarding the appropriate interval of amenorrhea before an episode of bleeding that allows for the definition of postmenopausal bleeding. The clinician faces the possibility that an underlying malignancy exists, knowing that most often the bleeding comes from a benign source. Formerly, the gold-standard clinical investigation of postmenopausal uterine bleeding was institution-based dilation and curettage, but there now exist office-based methods for the evaluation of women with this complaint. Strategies designed to implement these diagnostic methods must be applied in a balanced way considering the resource utilization issues of overinvestigation and the risk of missing a malignancy with underinvestigation. Consequently, guidelines and recommendations were developed to consider these issues and the diverse spectrum of practitioners who evaluate women with postmenopausal bleeding. The guideline development group determined that, for initial management of spontaneous postmenopausal bleeding, primary assessment may be with either endometrial sampling or transvaginal ultrasonography, allowing patients with an endometrial echo complex thickness of 4 mm or less to be managed expectantly. Guidelines are also provided for patients receiving selective estrogen receptor modulators or hormone replacement therapy, and for an endometrial echo complex with findings consistent with fluid in the endometrial cavity. PMID:24377427

Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.

PubMed

Shakur, Haleema; Roberts, Ian; Bautista, Raúl; Caballero, José; Coats, Tim; Dewan, Yashbir; El-Sayed, Hesham; Gogichaishvili, Tamar; Gupta, Sanjay; Herrera, Jorge; Hunt, Beverley; Iribhogbe, Pius; Izurieta, Mario; Khamis, Hussein; Komolafe, Edward; Marrero, María-Acelia; Mejía-Mantilla, Jorge; Miranda, Jaime; Morales, Carlos; Olaomi, Oluwole; Olldashi, Fatos; Perel, Pablo; Peto, Richard; Ramana, P V; Ravi, R R; Yutthakasemsunt, Surakrant

2010-07-03

Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919. 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077). Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.

Association between osteoporosis and periodontal disease among postmenopausal Indian women.

PubMed

Richa; R, Yashoda; Puranik, Manjunath P; Shrivastava, Amit

2017-08-01

The aim of the present study was to determine the association between osteoporosis and periodontal disease among postmenopausal Indian women. A cross-sectional comparative study was conducted among postmenopausal women aged 45-65 years attending various hospitals in Bangalore, India. The examination was performed using the plaque index, gingival index, modified sulcus bleeding index, and community periodontal index. The women then underwent a bone mineral density (BMD) test using an ultrasonometer. Based on the BMD scores, participants were divided into osteoporotic and non-osteoporotic groups. For the statistical analysis, χ 2 -test, Student's t-test, and multiple regression analysis were applied. The mean plaque, gingival, and bleeding scores were significantly higher among osteoporotic women (1.83 ± 0.47, 1.73 ± 0.49, 1.82 ± 0.52) compared to the non-osteoporotic women (1.31 ± 0.40, 1.09 ± 0.52, 1.25 ± 0.50). The mean number of sextants affected for codes 3 and 4 of the community periodontal index and codes 1, 2, and 3 of loss of attachment were significantly higher among osteoporotic group compared to the non-osteoporotic group. Multiple logistic regression tests confirmed the statistically-significant association between osteoporosis and menopause duration, loss of attachment, bleeding, and gingivitis scores. Skeletal BMD is related to clinical attachment loss, bleeding, and gingivitis, which suggests that there is an association between osteoporosis and periodontal diseases. © 2016 John Wiley & Sons Australia, Ltd.

Abnormal Uterine Bleeding: Current Classification and Clinical Management.

PubMed

Bacon, Janice L

2017-06-01

Abnormal uterine bleeding is now classified and categorized according to the International Federation of Gynecology and Obstetrics classification system: PALM-COEIN. This applies to nongravid women during their reproductive years and allows more clear designation of causes, thus aiding clinical care and future research. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety and cost-effectiveness of bridge therapies for invasive dental procedures in patients with mechanical heart valves.

PubMed

Won, Ki-Bum; Lee, Seung-Hyun; Chang, Hyuk-Jae; Shim, Chi-Young; Hong, Gue-Ru; Ha, Jong-Won; Chung, Namsik

2014-07-01

Bridge anticoagulation therapy is mostly utilized in patients with mechanical heart valves (MHV) receiving warfarin therapy during invasive dental procedures because of the risk of excessive bleeding related to highly vascular supporting dental structures. Bridge therapy using low molecular weight heparin may be an attractive option for invasive dental procedures; however, its safety and cost-effectiveness compared with unfractionated heparin (UFH) is uncertain. This study investigated the safety and cost-effectiveness of enoxaparin in comparison to UFH for bridge therapy in 165 consecutive patients (57±11 years, 35% men) with MHV who underwent invasive dental procedures. This study included 75 patients treated with UFH-based bridge therapy (45%) and 90 patients treated with enoxaparin-based bridge therapy (55%). The bleeding risk of dental procedures and the incidence of clinical adverse outcomes were not significantly different between the UFH group and the enoxaparin group. However, total medical costs were significantly lower in the enoxaparin group than in the UFH group (p<0.001). After multivariate adjustment, old age (≥65 years) was significantly associated with an increased risk of total bleeding independent of bridging methods (odds ratio, 2.51; 95% confidence interval, 1.15-5.48; p=0.022). Enoxaparin-based bridge therapy (β=-0.694, p<0.001) and major bleeding (β=0.296, p=0.045) were significantly associated with the medical costs within 30 days after dental procedures. Considering the benefit of enoxaparin in cost-effectiveness, enoxaparin may be more efficient than UFH for bridge therapy in patients with MHV who required invasive dental procedures.

Measurement of utility values in the UK for health states related to immune thrombocytopenic purpura.

PubMed

Szende, Agota; Brazier, John; Schaefer, Caroline; Deuson, Robert; Isitt, John J; Vyas, Paresh

2010-08-01

To measure utility values associated with immune (idiopathic) thrombocytopenic purpura (ITP), as perceived by the United Kingdom (UK) general public. A multi-step process, including clinical trial data, literature review, and patient focus group, was used to develop ITP health states valued in a web survey. Six ITP health states were defined based on platelet levels, risk of bleeding and key adverse events/disease complications. Clinical trial data on bleeding and ITP-specific quality of life data were key sources for developing health-state descriptions. 359 respondents, randomly selected from a managed web panel in the UK, completed the web-based Time Trade-Off survey. Wilcoxon signed-rank test was used to compare differences between each pair of health states. Sample characteristics (mean age: 47.9 +/- 16.9 years; 54% female) were comparable to the UK general population. ITP health states were valued as significantly worse than perfect health. Experiencing bleeding episodes was a more important driver than low platelet levels in valuing a health state to be worse. Substantial disutilities were associated with surviving an intracranial haemorrhage. Mean (SD) utility values for each ITP health state are: HS1: platelets >or=50 x 10(9)/L, no outpatient bleed: 0.863 +/- 0.15; HS2: platelets >or=50 x 10(9)/L, outpatient bleed: 0.734 +/- 0.19; HS3: platelets <50 x 10(9)/L, no outpatient bleed: 0.841 +/- 0.19; HS4: platelets <50 x 10(9)/L, outpatient bleed: 0.732 +/- 0.19; HS5: intracranial haemorrhage (2-6 months): 0.038 +/- 0.46; HS6: steroid treatment adverse events: 0.758 +/- 0.20. Potential limitations relate to web user population characteristics and lack of comparative testing of web-based TTO methods. Results provide evidence that the UK general population associate substantial loss of value living with ITP, suggesting an important role for new ITP treatments. Utility values based on these health states may be useful in future cost-effectiveness studies of existing and/or new ITP treatments.

Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes.

PubMed

Alfredsson, Joakim; Neely, Benjamin; Neely, Megan L; Bhatt, Deepak L; Goodman, Shaun G; Tricoci, Pierluigi; Mahaffey, Kenneth W; Cornel, Jan H; White, Harvey D; Fox, Keith Aa; Prabhakaran, Dorairaj; Winters, Kenneth J; Armstrong, Paul W; Ohman, E Magnus; Roe, Matthew T

2017-08-01

Dual antiplatelet therapy (DAPT) with aspirin + a P2Y12 inhibitor is recommended for at least 12 months for patients with acute coronary syndrome (ACS), with shorter durations considered for patients with increased bleeding risk. However, there are no decision support tools available to predict an individual patient's bleeding risk during DAPT treatment in the post-ACS setting. To develop a longitudinal bleeding risk prediction model, we analy sed 9240 patients with unstable angina/non-ST segment elevation myocardial infarction (NSTEMI) from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial, who were managed without revasculari sation and treated with DAPT for a median of 14.8 months. We identified 10 significant baseline predictors of non-coronary artery bypass grafting (CABG)-related Global Use of Strategies to Open Occluded Arteries (GUSTO) severe/life-threatening/moderate bleeding: age, sex, weight, NSTEMI (vs unstable angina), angiography performed before randomi sation, prior peptic ulcer disease, creatinine, systolic blood pressure, haemoglobin and treatment with beta-blocker. The five significant baseline predictors of Thrombolysis In Myocardial Infarction (TIMI) major or minor bleeding included age, sex, angiography performed before randomi sation, creatinine and haemoglobin. The models showed good predictive accuracy with Therneau's C- indices: 0.78 (SE = 0.024) for the GUSTO model and 0.67 (SE = 0.023) for the TIMI model. Internal validation with bootstrapping gave similar C -indices of 0.77 and 0.65, respectively. External validation demonstrated an attenuated C -index for the GUSTO model (0.69) but not the TIMI model (0.68). Longitudinal bleeding risks during treatment with DAPT in patients with ACS can be reliably predicted using selected baseline characteristics. The TRILOGY ACS bleeding models can inform risk -benefit considerations regarding the duration of DAPT following ACS. ClinicalTrials.gov identifier: https://clinicaltrials.gov/ct2/show/NCT00699998. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical significance of residual platelet reactivity in patients treated with platelet P2Y12 inhibitors.

PubMed

Thomas, Mark R; Storey, Robert F

2016-09-01

Platelet P2Y12 inhibitors have become an essential component of the treatment strategy for patients with acute coronary syndromes and patients undergoing percutaneous coronary intervention. It is now well-established that approximately 30% of patients treated with the P2Y12 inhibitor clopidogrel display high residual platelet reactivity despite treatment. Patients with high on-treatment platelet reactivity have approximately 2-3-fold greater risk of adverse cardiovascular events and stent thrombosis than those without high platelet reactivity. Conversely, clopidogrel-treated patients with low platelet reactivity display approximately 1.7-fold increased risk of major bleeding. High platelet reactivity is uncommon during treatment with prasugrel and ticagrelor, which achieve a greater reduction in adverse cardiovascular events compared to clopidogrel in ACS patients treated with PCI. This is at the expense of an increase in spontaneous bleeding, however. Minor bleeding events, such as skin haematomas, are more common in prasugrel- and ticagrelor-treated patients that have particularly low platelet reactivity values. These minor bleeding events may occasionally prompt discontinuation of therapy, but their overall prognostic impact is uncertain. However, risk factors for bleeding tend to overlap with risk factors for adverse cardiovascular events. Therefore, patients with these minor bleeding events may also be at higher risk of adverse cardiovascular events, conferring a benefit from low platelet reactivity. Further work is needed to determine the optimal level of platelet reactivity in individuals by taking into account their risk of subsequent adverse cardiovascular events and bleeding. Copyright © 2016 Elsevier Inc. All rights reserved.

Biomaterials and Advanced Technologies for Hemostatic Management of Bleeding.

PubMed

Hickman, DaShawn A; Pawlowski, Christa L; Sekhon, Ujjal D S; Marks, Joyann; Gupta, Anirban Sen

2018-01-01

Bleeding complications arising from trauma, surgery, and as congenital, disease-associated, or drug-induced blood disorders can cause significant morbidities and mortalities in civilian and military populations. Therefore, stoppage of bleeding (hemostasis) is of paramount clinical significance in prophylactic, surgical, and emergency scenarios. For externally accessible injuries, a variety of natural and synthetic biomaterials have undergone robust research, leading to hemostatic technologies including glues, bandages, tamponades, tourniquets, dressings, and procoagulant powders. In contrast, treatment of internal noncompressible hemorrhage still heavily depends on transfusion of whole blood or blood's hemostatic components (platelets, fibrinogen, and coagulation factors). Transfusion of platelets poses significant challenges of limited availability, high cost, contamination risks, short shelf-life, low portability, performance variability, and immunological side effects, while use of fibrinogen or coagulation factors provides only partial mechanisms for hemostasis. With such considerations, significant interdisciplinary research endeavors have been focused on developing materials and technologies that can be manufactured conveniently, sterilized to minimize contamination and enhance shelf-life, and administered intravenously to mimic, leverage, and amplify physiological hemostatic mechanisms. Here, a comprehensive review regarding the various topical, intracavitary, and intravenous hemostatic technologies in terms of materials, mechanisms, and state-of-art is provided, and challenges and opportunities to help advancement of the field are discussed. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Prognostic Value of AIMS65 Score in Cirrhotic Patients with Upper Gastrointestinal Bleeding.

PubMed

Gaduputi, Vinaya; Abdulsamad, Molham; Tariq, Hassan; Rafeeq, Ahmed; Abbas, Naeem; Kumbum, Kavitha; Chilimuri, Sridhar

2014-01-01

Introduction. Unlike Rockall scoring system, AIMS65 is based only on clinical and laboratory features. In this study we investigated the correlation between the AIMS65 score and Endoscopic Rockall score, in cirrhotic and noncirrhotic patients. Methods. This is a retrospective study of patients admitted with overt UGIB and undergoing esophagogastroduodenoscopy (EGD). AIMS65 and Rockall scores were calculated at the time of admission. We investigated the correlation between both scores along with stigmata of bleed seen on endoscopy. Results. A total of 1255 patients were studied. 152 patients were cirrhotic while 1103 patients were noncirrhotic. There was significant correlation between AIMS65 and Total Rockall scores in patients of both groups. There was significant correlation between AIMS65 score and Endoscopic Rockall score in noncirrhotics but not cirrhotics. AIMS65 scores in both cirrhotic and noncirrhotic groups were significantly higher in patients who died from UGIB than in patients who did not. Conclusion. We observed statistically significant correlation between AIMS65 score and length of hospitalization and mortality in noncirrhotic patients. We found that AIMS65 score paralleled the endoscopic grading of lesion causing UGIB in noncirrhotics. AIMS65 score correlated only with mortality but not the length of hospitalization or endoscopic stigmata of bleed in cirrhotics.

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis.

PubMed

López-Picado, Amanda; Lapuente, Oihane; Lete, Iñaki

2017-04-01

To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC). The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched. Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I 2 statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity. 4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26-1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46-0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12-1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51-0.91]). Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

Dabigatran - Metabolism, Pharmacologic Properties and Drug Interactions.

PubMed

Antonijevic, Nebojsa M; Zivkovic, Ivana D; Jovanovic, Ljubica M; Matic, Dragan M; Kocica, Mladen J; Mrdovic, Igor B; Kanjuh, Vladimir I; Culafic, Milica D

2017-01-01

The superiority of dabigatran has been well proven in the standard dosing regimen in prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and extended venous thromboembolism (VTE) treatment. Dabigatran, an anticoagulant with a good safety profile, reduces intracranial bleeding in patients with atrial fibrillation and decreases major and clinically relevant non-major bleeding in acute VTE treatment. However, several important clinical issues are not fully covered by currently available directions with regard to dabigatran administration. The prominent one is reflected in the fact that dynamic impairment in renal function due to dehydratation may lead to haemorragic complications on the one hand, while on the other hand glomerular hyperfiltration may be a possible cause of dabigatran subdosing, hence reducing the drug's efficacy. Furthermore, limitations of the Cockcroft-Gault formula, considered a standard equation for assessing the renal function, may imply that other calculations are likely to obtain more accurate estimates of the kidney function in specific patient populations. Method and Conclusions: Although not routinely recommended, a possibility of monitoring dabigatran in special clinical settings adds to optimization of its dosage regimens, timely perioperative care and administration of urgently demanded thrombolytic therapy, therefore significantly improving this drug's safety profile. Despite the fact that dabigatran has fewer reported interactions with drugs, food constituents, and dietary supplements, certain interactions still remain, requiring considerable caution, notably in elderly, high bleeding risk patients, patients with decreased renal function and those on complex drug regimens. Additionally, upon approval of idarucizumab, an antidote to dabigatran solution, hitherto being a major safety concern, has been finally reached, which plays a vital role in life-threatening bleeding and emergency interventions and surgery. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Clinical Outcomes of the Marginal Ulcer Bleeding after Gastrectomy: As Compared to the Peptic Ulcer Bleeding with Nonoperated Stomach

PubMed Central

Chung, Woo Chul; Jeon, Eun Jung; Lee, Kang-Moon; Paik, Chang Nyol; Oh, You Suk; Lee, Yang Woon; Kim, Sang Bae; Jun, Kyong-Hwa; Chin, Hyung Min

2012-01-01

Background. Marginal ulcer is a well-known complication after gastrectomy. Its bleeding can be severe, but the severity has rarely been reported. We aim to evaluate the clinical outcomes of marginal ulcer bleeding (MUB) as compared to peptic ulcer bleeding (PUB) with nonoperated stomach. Methods. A consecutive series of patients who had nonvariceal upper gastrointestinal bleeding and admitted to the hospital between 2005 and 2011 were retrospectively analyzed. A total of 530 patients were enrolled in this study, and we compared the clinical characteristics between 70 patients with MUB and 460 patients with PUB. Results. Patients with MUB were older (mean age: 62.86 ± 10.59 years versus 53.33 ± 16.68 years, P = 0.01). The initial hemoglobin was lower (8.16 ± 3.05 g/dL versus 9.38 ± 2.49 g/dL, P = 0.01), and the duration of admission was longer in MUB (7.14 ± 4.10 days versus 5.90 ± 2.97 days, P = 0.03). After initial hemostasis, the rebleeding rate during admission was higher (16.2% versus 6.5%, P = 0.01) in MUB. However, the mortality rate did not differ statistically between MUB and PUB groups. Helicobacter pylori-positive rate with MUB was lower than that of PUB (19.4% versus 54.4%, P = 0.01). Conclusions. Clinically, MUB after gastrectomy is more severe than PUB with nonoperated stomach. Infection with H. pylori might not appear to play an important role in MUB after gastrectomy. PMID:23304127

Physiotherapy home exercise program for haemophiliacs.

PubMed

Pierstorff, K; Seuser, A; Weinspach, S; Laws, H-J

2011-05-01

Regular physiotherapy can improve the stability and flexibility of joints and decrease the bleeding risk in patients with haemophilia. To reduce the appointments for the patients and to make exercising a part of daily live, an individualized home exercise program (HEP) was designed. Retrospectively the number of bleedings during the HEP was compared to number of bleedings before. 8 patients aged between 4 and 16 years with haemophilia A were evaluated. At start and after 13 month patients had a motion analysis via topographic ultrasound. According to the results and clinical findings an individualized HEP was created. Standardised scores for clinical evaluation and the patient based evaluation of exercises were designed. At every appointment exercises were individually adjusted. Patients exercised in median 1.7 times a week. No training related bleeds occurred. 7 of 8 patients showed reduced joint and/or muscle bleeds (p<0.02). Clinical scores raised slightly in every patient. However the second motion analysis of squat and gait showed a worsening in 7 of 8 patients (p>0.05). A HEP can help to advance in physical fitness and coordination and may reduce bleeding tendency, but needs to be accomplished regularly. Patients are interested but the motivation to exercise at home is low. Disorders measured by motion analysis seem not to be sufficiently influenced by our surrogate training program. © Georg Thieme Verlag KG Stuttgart · New York.

Congenital afibrinogenemia: from etiopathogenesis to challenging clinical management.

PubMed

Stanciakova, Lucia; Kubisz, Peter; Dobrotova, Miroslava; Stasko, Jan

2016-07-01

Congenital afibrinogenemia belongs to the group of autosomal recessive bleeding disorders and represents the absolute deficiency of fibrinogen detected by an antigenic test. This can lead to severe clinical manifestations of the disorder. Therefore, it is very important to take afibrinogenemia into account in the process of the differential diagnostics of the patients. The authors provide a summary of currently available literature about afibrinogenemia. They collected the information from the scientific journals dedicated to thrombosis and hemostasis and searched world-wide databases. Expert commentary: The most frequent clinical manifestation of this disorder is mucosal bleeding, but musculoskeletal bleeding pattern, gynecologic and obstetric issues, spontaneous bleeding, episodes provoked by minor injury or any other intervention, and even paradoxical thromboembolic events have been published. Afibrinogenemia is the consequence of mutations of the homozygous or compound heterozygous type in gene FGA, FGB or FGG encoding fibrinogen. Pregnant women with a family history, or with a history of consanguinity ought to be properly counselled. However, primary prophylaxis of bleeding events is not suggested. The article deals with actual information about afibrinogenemia contributing to its early diagnosis and effective treatment, which in many cases requires multidisciplinary approach.

Focused ultrasound: concept for automated transcutaneous control of hemorrhage in austere settings.

PubMed

Kucewicz, John C; Bailey, Michael R; Kaczkowski, Peter J; Carter, Stephen J

2009-04-01

High intensity focused ultrasound (HIFU) is being developed for a range of clinical applications. Of particular interest to NASA and the military is the use of HIFU for traumatic injuries because HIFU has the unique ability to transcutaneously stop bleeding. Automation of this technology would make possible its use in remote, austere settings by personnel not specialized in medical ultrasound. Here a system to automatically detect and target bleeding is tested and reported. The system uses Doppler ultrasound images from a clinical ultrasound scanner for bleeding detection and hardware for HIFU therapy. The system was tested using a moving string to simulate blood flow and targeting was visualized by Schlieren imaging to show the focusing of the HIFU acoustic waves. When instructed by the operator, a Doppler ultrasound image is acquired and processed to detect and localize the moving string, and the focus of the HIFU array is electronically adjusted to target the string. Precise and accurate targeting was verified in the Schlieren images. An automated system to detect and target simulated bleeding has been built and tested. The system could be combined with existing algorithms to detect, target, and treat clinical bleeding.

Clinical research for delayed hemorrhage after endoscopic sphincterotomy

PubMed Central

Wang, Yundong; Han, Zhen; Niu, Xiaoping; Jia, Yuliang; Yuan, Heming; Zhang, Guozheng; He, Chiyi

2015-01-01

To analyze the effect of delayed hemorrhage after endoscopic sphincterotomy (EST) and compare the efficacy in improving complication between medicine treatment alone and medicine combined with endoscopic treatment. 1741 patients with EST admitted in Yijishan hospital of Wannan medical college from September 2009 to May 2014 were enrolled in this study. 32 cases suffered from delayed hemorrhage. The patients with delayed hemorrhage were evaluated through incision length of duodenal papilla, clinical manifestation, stool occult blood test and the difference of hemoglobin concentration between pre and post operation. 32 patients were divided into mild bleeding group, mild serious group and serious group through the speed and amount of bleeding. All cases in mild group accepted medicine treatment. Mild serious group were divided into medicine therapy group and medicine combined with endoscopic therapy group randomly. Serious group accepted vascular intervention therapy even traditional operation. The different treatments for delayed hemorrhage were judged by efficiency. The dates were analyzed by t-test or chi-square test. Nobody endured delayed hemorrhage who accepted small incision. Delayed hemorrhage was found in 7 patients out of 627 cases who accepted medium-large incision, 25 patients of 920 cases who accepted large incision. The patients who accepted lager EST were more dangerous than small EST (χ2=4.718, P=0.030) concerning delayed hemorrhage. 32 cases in 1741 patients suffered from delayed hemorrhage. 14 patients only have passed black stool after EST. Among 14 cases, 13 patients stop bleeding after medical therapy, and 1 case received endoscopic hemostasis. 15 cases with hematemesis or melena after EST, 7 patients who received combination therapy stop bleeding. 3 patients from 8 cases stop bleeding after single chemical treatment, 5 cases had to receive endoscopic hemostasis after ineffectual medical therapy. There are significant difference for concerning effect between combination therapy group and medical therapy group (P=0.026). 3 patients repeatedly vomited blood and develop to peripheral circulatory failure. Those patients all received vascular intervention therapy, 2 patients stop bleeding, 1 patient failed in vascular intervention therapy and given up emergency rescue and died. Large EST has more risks than small EST in concerning delayed hemorrhage. Delayed bleeding after EST should be treated by different levels. Adapted therapy should be recommend for patients with different levels bleeding. PMID:26131161

Use of global assays to understand clinical phenotype in congenital factor VII deficiency.

PubMed

Greene, L A; Goldenberg, N A; Simpson, M L; Villalobos-Menuey, E; Bombardier, C; Acharya, S S; Santiago-Borrero, P J; Cambara, A; DiMichele, D M

2013-09-01

Congenital factor VII (FVII) deficiency is characterized by genotypic variability and phenotypic heterogeneity. Traditional screening and factor assays are unable to reliably predict clinical bleeding phenotype and guide haemorrhage prevention strategy. Global assays of coagulation and fibrinolysis may better characterize overall haemostatic balance and aid in haemorrhagic risk assessment. We evaluated the ability of novel global assays to better understand clinical bleeding severity in congenital FVII deficiency. Subjects underwent central determination of factor VII activity (FVII:C) as well as clot formation and lysis (CloFAL) and simultaneous thrombin and plasmin generation (STP) global assay analysis. A bleeding score was assigned to each subject through medical chart review. Global assay parameters were analysed with respect to bleeding score and FVII:C. Subgroup analyses were performed on paediatric subjects and subjects with FVII ≥ 1 IU dL(-1). CloFAL fibrinolytic index (FI2 ) inversely correlated with FVII:C while CloFAL maximum amplitude (MA) and STP maximum velocity of thrombin generation (VT max) varied directly with FVII:C. CloFAL FI2 directly correlated with bleeding score among subjects in both the total cohort and paediatric subcohort, but not among subjects with FVII ≥ 1 IU dL(-1) . Among subjects with FVII ≥ 1 IU dL(-1), STP time to maximum velocity of thrombin generation and time to maximum velocity of plasmin generation inversely correlated with bleeding score. These preliminary findings suggest a novel potential link between a hyperfibrinolytic state in bleeding severity and congenital FVII deficiency, an observation that should be further explored. © 2013 John Wiley & Sons Ltd.

First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases.

PubMed

Richter-Schrag, Hans-Jürgen; Glatz, Torben; Walker, Christine; Fischer, Andreas; Thimme, Robert

2016-11-07

To evaluate rebleeding, primary failure (PF) and mortality of patients in whom over-the-scope clips (OTSCs) were used as first-line and second-line endoscopic treatment (FLET, SLET) of upper and lower gastrointestinal bleeding (UGIB, LGIB). A retrospective analysis of a prospectively collected database identified all patients with UGIB and LGIB in a tertiary endoscopic referral center of the University of Freiburg, Germany, from 04-2012 to 05-2016 ( n = 93) who underwent FLET and SLET with OTSCs. The complete Rockall risk scores were calculated from patients with UGIB. The scores were categorized as < or ≥ 7 and were compared with the original Rockall data. Differences between FLET and SLET were calculated. Univariate and multivariate analysis were performed to evaluate the factors that influenced rebleeding after OTSC placement. Primary hemostasis and clinical success of bleeding lesions (without rebleeding) was achieved in 88/100 (88%) and 78/100 (78%), respectively. PF was significantly lower when OTSCs were applied as FLET compared to SLET (4.9% vs 23%, P = 0.008). In multivariate analysis, patients who had OTSC placement as SLET had a significantly higher rebleeding risk compared to those who had FLET (OR 5.3; P = 0.008). Patients with Rockall risk scores ≥ 7 had a significantly higher in-hospital mortality compared to those with scores < 7 (35% vs 10%, P = 0.034). No significant differences were observed in patients with scores < or ≥ 7 in rebleeding and rebleeding-associated mortality. Our data show for the first time that FLET with OTSC might be the best predictor to successfully prevent rebleeding of gastrointestinal bleeding compared to SLET. The type of treatment determines the success of primary hemostasis or primary failure.

Haemophilia A carriers experience reduced health-related quality of life.

PubMed

Gilbert, L; Paroskie, A; Gailani, D; Debaun, M R; Sidonio, R F

2015-11-01

Haemophilia A is an X-linked recessive bleeding disorder that primarily affects males. Emerging data support evidence for increased bleeding in female haemophilia A carriers despite factor VIII activity within the normal range. Data regarding the effect of increased bleeding on health-related quality of life (HR-QOL) in haemophilia A carriers is sparse. We tested the hypothesis that haemophilia A carriers have reduced HR-QOL related to bleeding symptoms. We conducted a cross-sectional study at Vanderbilt University. Case subjects were obligate or genetically verified haemophilia A carriers age 18-60 years. Control subjects were mothers of children with cancer who receive care at the Vanderbilt paediatric haematology-oncology clinic. Trained interviewers administered the Rand 36-Item Health Survey 1.0, a validated questionnaire evaluating eight health concepts that may affect HR-QOL, to each study participant. Mann-Whitney U-tests were used to compare median scores for the eight health domains between the case and control groups. Forty-two haemophilia A carriers and 36 control subjects were included in analyses. Haemophilia A carriers had significantly lower median scores for the domains of 'Pain' (73.75 vs. 90; P = 0.02) and 'General health' (75 vs. 85; P = 0.01) compared to control subjects. Haemophilia A carriers in our study demonstrated significantly lower median scores on the Rand 36-item Health Survey 1.0 in the domains of 'Pain' and 'General Health' compared to women in the control group. Our findings highlight the need for further investigation of the effect of bleeding on HR-QOL in this population. © 2015 John Wiley & Sons Ltd.

Evaluation of hemostatic and fibrinolytic markers in dogs with ascites attributable to right-sided congestive heart failure.

PubMed

Zoia, Andrea; Augusto, Monica; Drigo, Michele; Caldin, Marco

2012-11-15

To determine whether dogs with ascites secondary to right-sided congestive heart failure (CHF) have bleeding disorders associated with hypofibrinogenemia and discordant plasma fibrin-fibrinogen degradation products (FDPs) and D-dimer assay results (ie, a circulating concentration of FDPs higher than the reference range and a circulating concentration of D-dimer within the reference range). Retrospective case-control study. 80 client-owned dogs. Dogs with ascites secondary to right-sided CHF (group 1; n = 20), unhealthy dogs without cardiac disease (group 2; 40), and dogs with left-sided CHF (group 3; 20) were included in the study. Urine bile acids-to-creatinine concentration ratios were calculated as a marker of liver function. Differences among groups regarding coagulation profile analysis results and prevalence of discordant FDPs and D-dimer assay results were determined. No significant differences were detected among the 3 groups regarding urine bile acids-to-creatinine concentration ratios. Plasma fibrinogen concentration was significantly lower for group 1 versus groups 2 or 3. Prevalence of discordant FDPs and D-dimer assay results was significantly higher for group 1 versus groups 2 or 3. Eighteen group 1 dogs had discordant FDPs and D-dimer assay results. Ten of these dogs had concurrent hypofibrinogenemia, 2 of which had clinical signs of bleeding. Only 10 dogs in groups 2 or 3 had discordant FDPs and D-dimer assay results; none of these dogs had hypofibrinogenemia or clinical signs of bleeding. Dogs with right-sided CHF and ascites may be at increased risk for primary hyperfibrinogenolysis (ie, hypofibrinogenemia and discordant FDPs and D-dimer assay results).

Characteristics of patients with non-variceal upper gastrointestinal bleeding taking antithrombotic agents.

PubMed

Yamaguchi, Daisuke; Sakata, Yasuhisa; Tsuruoka, Nanae; Shimoda, Ryo; Higuchi, Toru; Sakata, Hiroyuki; Fujimoto, Kazuma; Iwakiri, Ryuichi

2015-01-01

The present study aimed to clarify the features and management of non-variceal upper gastrointestinal bleeding (UGIB) in Japanese patients taking antithrombotic agents. We retrospectively investigated the medical records of 560 patients who underwent emergency endoscopy for UGIB from 2002 to 2013. The patients were divided into two groups: group A, antithrombotic agent use; and group NA, no antithrombotic agent use. We compared clinical characteristics, comorbidities, and causes of UGIB between the groups. We also investigated management with antithrombotics. Of 560 patients with UGIB, 27.5% were taking antithrombotics, and this proportion gradually increased during the study period. Mean hemoglobin levels on admission were significantly lower in group A (8.0 ± 1.7 g/dL) than in group NA (8.9 ± 2.9 g/dL) (P < 0.001). Patients in group A developed more gastric ulcers and multiple ulcers than did patients in group NA. Incidence of Forrest Ia-type bleeding was lower in group A than in group NA (P < 0.001), and the rate of endoscopic hemostasis was significantly higher in group A (98.7%) than in group NA (94.3%) (P = 0.022). After the release of the 2012 Japan Gastroenterological Endoscopy Society guidelines, the antithrombotic agent cessation periods were significantly shortened (P < 0.001). Among patients with UGIB, those taking antithrombotics exhibited more severe clinical signs. However spurting hemorrhage was rare. Antithrombotics may be resumed early after endoscopic hemostasis. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty.

PubMed

Anderson, David R; Dunbar, Michael; Murnaghan, John; Kahn, Susan R; Gross, Peter; Forsythe, Michael; Pelet, Stephane; Fisher, William; Belzile, Etienne; Dolan, Sean; Crowther, Mark; Bohm, Eric; MacDonald, Steven J; Gofton, Wade; Kim, Paul; Zukor, David; Pleasance, Susan; Andreou, Pantelis; Doucette, Steve; Theriault, Chris; Abianui, Abongnwen; Carrier, Marc; Kovacs, Michael J; Rodger, Marc A; Coyle, Doug; Wells, Philip S; Vendittoli, Pascal-Andre

2018-02-22

Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], -0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43). Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).

Long-term prognosis in patients continuing taking antithrombotics after peptic ulcer bleeding

PubMed Central

Wang, Xi-Xu; Dong, Bo; Hong, Biao; Gong, Yi-Qun; Wang, Wei; Wang, Jue; Zhou, Zhen-Yu; Jiang, Wei-Jun

2017-01-01

AIM To investigate the long-term prognosis in peptic ulcer patients continuing taking antithrombotics after ulcer bleeding, and to determine the risk factors that influence the prognosis. METHODS All clinical data of peptic ulcer patients treated from January 1, 2009 to January 1, 2014 were retrospectively collected and analyzed. Patients were divided into either a continuing group to continue taking antithrombotic drugs after ulcer bleeding or a discontinuing group to discontinue antithrombotic drugs. The primary outcome of follow-up in peptic ulcer bleeding patients was recurrent bleeding, and secondary outcome was death or acute cardiovascular disease occurrence. The final date of follow-up was December 31, 2014. Basic demographic data, complications, and disease classifications were analyzed and compared by t- or χ2-test. The number of patients that achieved various outcomes was counted and analyzed statistically. A survival curve was drawn using the Kaplan-Meier method, and the difference was compared using the log-rank test. COX regression multivariate analysis was applied to analyze risk factors for the prognosis of peptic ulcer patients. RESULTS A total of 167 patients were enrolled into this study. As for the baseline information, differences in age, smoking, alcohol abuse, and acute cardiovascular diseases were statistically significant between the continuing and discontinuing groups (70.8 ± 11.4 vs 62.4 ± 12.0, P < 0.001; 8 (8.2%) vs 15 (21.7%), P < 0.05; 65 (66.3%) vs 13 (18.8%), P < 0.001). At the end of the study, 18 patients had recurrent bleeding and three patients died or had acute cardiovascular disease in the continuing group, while four patients had recurrent bleeding and 15 patients died or had acute cardiovascular disease in the discontinuing group. The differences in these results were statistically significant (P = 0.022, P = 0.000). The Kaplan-Meier survival curve indicated that the incidence of recurrent bleeding was higher in patients in the continuing group, and the risk of death and developing acute cardiovascular disease was higher in patients in the discontinuing group (log-rank test, P = 0.000 for both). Furthermore, COX regression multivariate analysis revealed that the hazard ratio (HR) for recurrent bleeding was 2.986 (95%CI: 067-8.356, P = 0.015) in the continuing group, while HR for death or acute cardiovascular disease was 5.216 (95%CI: 1.035-26.278, P = 0.028). CONCLUSION After the occurrence of peptic ulcer bleeding, continuing antithrombotics increases the risk of recurrent bleeding events, while discontinuing antithrombotics would increase the risk of death and developing cardiovascular disease. This suggests that clinicians should comprehensively consider the use of antithrombotics after peptic ulcer bleeding. PMID:28216980

Long-term prognosis in patients continuing taking antithrombotics after peptic ulcer bleeding.

PubMed

Wang, Xi-Xu; Dong, Bo; Hong, Biao; Gong, Yi-Qun; Wang, Wei; Wang, Jue; Zhou, Zhen-Yu; Jiang, Wei-Jun

2017-01-28

To investigate the long-term prognosis in peptic ulcer patients continuing taking antithrombotics after ulcer bleeding, and to determine the risk factors that influence the prognosis. All clinical data of peptic ulcer patients treated from January 1, 2009 to January 1, 2014 were retrospectively collected and analyzed. Patients were divided into either a continuing group to continue taking antithrombotic drugs after ulcer bleeding or a discontinuing group to discontinue antithrombotic drugs. The primary outcome of follow-up in peptic ulcer bleeding patients was recurrent bleeding, and secondary outcome was death or acute cardiovascular disease occurrence. The final date of follow-up was December 31, 2014. Basic demographic data, complications, and disease classifications were analyzed and compared by t - or χ 2 -test. The number of patients that achieved various outcomes was counted and analyzed statistically. A survival curve was drawn using the Kaplan-Meier method, and the difference was compared using the log-rank test. COX regression multivariate analysis was applied to analyze risk factors for the prognosis of peptic ulcer patients. A total of 167 patients were enrolled into this study. As for the baseline information, differences in age, smoking, alcohol abuse, and acute cardiovascular diseases were statistically significant between the continuing and discontinuing groups (70.8 ± 11.4 vs 62.4 ± 12.0, P < 0.001; 8 (8.2%) vs 15 (21.7%), P < 0.05; 65 (66.3%) vs 13 (18.8%), P < 0.001). At the end of the study, 18 patients had recurrent bleeding and three patients died or had acute cardiovascular disease in the continuing group, while four patients had recurrent bleeding and 15 patients died or had acute cardiovascular disease in the discontinuing group. The differences in these results were statistically significant ( P = 0.022, P = 0.000). The Kaplan-Meier survival curve indicated that the incidence of recurrent bleeding was higher in patients in the continuing group, and the risk of death and developing acute cardiovascular disease was higher in patients in the discontinuing group (log-rank test, P = 0.000 for both). Furthermore, COX regression multivariate analysis revealed that the hazard ratio (HR) for recurrent bleeding was 2.986 (95%CI: 067-8.356, P = 0.015) in the continuing group, while HR for death or acute cardiovascular disease was 5.216 (95%CI: 1.035-26.278, P = 0.028). After the occurrence of peptic ulcer bleeding, continuing antithrombotics increases the risk of recurrent bleeding events, while discontinuing antithrombotics would increase the risk of death and developing cardiovascular disease. This suggests that clinicians should comprehensively consider the use of antithrombotics after peptic ulcer bleeding.

Bleeding rates in Veterans Affairs patients with atrial fibrillation who switch from warfarin to dabigatran.

PubMed

Vaughan Sarrazin, Mary S; Jones, Michael; Mazur, Alexander; Chrischilles, Elizabeth; Cram, Peter

2014-12-01

Clinical trial data suggest that dabigatran and warfarin have similar rates of major bleeding but higher rates of gastrointestinal bleeding. These findings have not been evaluated outside of a clinical trial. We evaluated the relative risks of any, gastrointestinal, intracranial, and other bleeding for Veterans Affairs patients who switched to dabigatran after at least 6 months on warfarin, compared with patients who continued on warfarin. We used national Veterans Affairs administrative encounter and pharmacy data from fiscal years 2010-2012 to identify 85,344 patients with atrial fibrillation who had been taking warfarin for at least 180 days before June 2011, of whom 1394 (1.7%) received dabigatran (150 mg) during the next 15 months. Dates of the first occurrence of each type of bleed and dates of death from June 2011 to September 2012 were determined. Baseline and time-dependent patient characteristics were identified, including comorbid conditions, stroke and bleeding risk scores, and time in therapeutic range for international normalized ratios. Marginal structural models were used to address selection bias in the longitudinal observational data. Weighted logistic regression models were fit using generalized estimating equations and reflected baseline and time-dependent covariates and weekly indicators of anticoagulant type (warfarin or dabigatran). Compared with patients who never used dabigatran, patients who used dabigatran at least once were younger, were more likely to be white, had lower international normalized ratio time in therapeutic range on warfarin, had lower stroke risk scores, and had similar bleeding risk scores. Overall, 10,734 patients experienced bleeding events, including 131 events after dabigatran use. The risk-adjusted rate of any bleeding was higher with dabigatran compared with warfarin, which was largely driven by a 54% higher risk of gastrointestinal bleeding with dabigatran. Rates of intracranial, other bleeding, and death were similar for dabigatran and warfarin. Dabigatran may increase the likelihood of gastrointestinal bleeds. Published by Elsevier Inc.

Short and long-term mortality of patients presenting with bleeding events to the Emergency Department.

PubMed

Conti, Alberto; Renzi, Noemi; Molesti, Daniele; Bianchi, Simone; Bogazzi, Irene; Bongini, Giada; Pepe, Giuseppe; Frosini, Fabiana; Bertini, Alessio; Santini, Massimo

2017-12-01

Death of patients presenting with bleeding events to the Emergency Department still represent a major problem. We sought to analyze clinical characteristics associated with worse outcomes including short- and long-term death, beyond antithombotic treatment strategy. Patients presenting with any bleeding events during 2016-2017years were enrolled. Clinical parameters, site of bleeding, major bleeding, ongoing anti-thrombotic treatment strategy and death were collected. Hard 5:1 propensity score matching was performed to adjust dead patients in baseline characteristics. Endpoints were one-month and one-year death. Out of 166,000 visits to the Emergency Department, 3.050 patients (1.8%) were enrolled and eventually 429 were analyzed after propensity. Overall, anticoagulants or antiplatelets were given to 234(54%). Major bleeding account for 111(26%) patients, without differences between those taking anticoagulants or antiplatelets versus others. Death at one-month and one-year was 26(6%) and 72(17%), respectively. Independent predictors of one-month death were major bleeding (Odds Ratio, OR 26, p<0.001), female gender (OR 7, p<0.001) and white blood cells (OR 1.2, p=0.01); of one-year were major bleeding (OR 7, p<0.001), age (OR 1.1, p<0.001) and female gender (OR 2.3, p=0.043). Of note, death rate of gastrointestinal and intracranial bleeding where higher than others (p<0.001). Overall mortality was approximately 40% on one-month; 60% in older patients and 80% in female gender with CHA 2 D 2 VASC-score≥2. Receiver operator characteristics analysis showed larger areas for major bleeding and age (0.75 and 0.72, respectively) over others; p<0.05 on C-statistic. In patients with bleeding events, death rate was driven by major bleeding on short-term and older age on long-term. Among dead patients mortality was approximately 40% on one-month; 60% in older patients, and 80% in female gender. Copyright © 2017 Elsevier Inc. All rights reserved.

Factors Associated With Major Bleeding Events

PubMed Central

Goodman, Shaun G.; Wojdyla, Daniel M.; Piccini, Jonathan P.; White, Harvey D.; Paolini, John F.; Nessel, Christopher C.; Berkowitz, Scott D.; Mahaffey, Kenneth W.; Patel, Manesh R.; Sherwood, Matthew W.; Becker, Richard C.; Halperin, Jonathan L.; Hacke, Werner; Singer, Daniel E.; Hankey, Graeme J.; Breithardt, Gunter; Fox, Keith A. A.; Califf, Robert M.

2014-01-01

Objectives This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). Background The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. Methods The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. Results The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Conclusions Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767) PMID:24315894

Effects of a 6-week, individualized, supervised exercise program for people with bleeding disorders and hemophilic arthritis.

PubMed

Mulvany, Ruth; Zucker-Levin, Audrey R; Jeng, Michael; Joyce, Catherine; Tuller, Janet; Rose, Jonathan M; Dugdale, Marion

2010-04-01

People with bleeding disorders may develop severe arthritis due to joint hemorrhages. Exercise is recommended for people with bleeding disorders, but guidelines are vague and few studies document efficacy. In this study, 65% of people with bleeding disorders surveyed reported participating in minimal exercise, and 50% indicated a fear of exercise-induced bleeding, pain, or physical impairment. The purpose of this study was to examine the feasibility, safety, and efficacy of a professionally designed, individualized, supervised exercise program for people with bleeding disorders. A single-group, pretest-posttest clinical design was used. Thirty-three patients (3 female, 30 male; 7-57 years of age) with mild to severe bleeding disorders were enrolled in the study. Twelve patients had co-existing illnesses, including HIV/AIDS, hepatitis, diabetes, fibromyalgia, neurofibromatosis, osteopenia, osteogenesis imperfecta, or cancer. Pre- and post-program measures included upper- and lower-extremity strength (force-generating capacity), joint range of motion, joint and extremity circumference, and distance walked in 6 minutes. Each patient was prescribed a 6-week, twice-weekly, individualized, supervised exercise program. Twenty participants (61%) completed the program. Pre- and post-program data were analyzed by paired t tests for all participants who completed the program. No exercise-induced injuries, pain, edema, or bleeding episodes were reported. Significant improvements occurred in joint motion, strength, and distance walked in 6 minutes, with no change in joint circumference. The greatest gains were among the individuals with the most severe joint damage and coexisting illness. Limitations included a small sample size with concomitant disease, which is common to the population, and a nonblinded examiner. A professionally designed and supervised, individualized exercise program is feasible, safe, and beneficial for people with bleeding disorders, even in the presence of concomitant disease. A longitudinal study with a larger sample size, a blinded examiner, and a control group is needed to confirm the results.

Anticoagulant therapy and outcomes in patients with prior or acute heart failure and acute coronary syndromes: Insights from the APixaban for PRevention of Acute ISchemic Events 2 trial.

PubMed

Cornel, Jan H; Lopes, Renato D; James, Stefan; Stevens, Susanna R; Neely, Megan L; Liaw, Danny; Miller, Julie; Mohan, Puneet; Amerena, John; Raev, Dimitar; Huo, Yong; Urina-Triana, Miguel; Gallegos Cazorla, Alex; Vinereanu, Dragos; Fridrich, Viliam; Harrington, Robert A; Wallentin, Lars; Alexander, John H

2015-04-01

Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome (ACS) and either a history of or acute heart failure (HF) are largely unknown. We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations. High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily. Median follow-up was 8 (4-12) months. The primary outcome was cardiovascular death, myocardial infarction, or stroke. The main safety outcome was thrombolysis in myocardial infarction major bleeding. Heart failure was reported in 2,995 patients (41%), either as prior HF (2,076 [28%]) or acute HF (2,028 [27%]). Patients with HF had a very high baseline risk and were more often managed medically. Heart failure was associated with a higher rate of the primary outcome (prior HF: adjusted hazard ratio [HR] 1.73, 95% CI 1.42-2.10, P < .0001, acute HF: adjusted HR 1.65, 95% CI 1.35-2.01, P < .0001) and cardiovascular death (prior HF: HR 2.54, 95% CI 1.82-3.54, acute HF: adjusted HR 2.52, 95% CI 1.82-3.50). Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding (prior HF: adjusted HR 1.22, 95% CI 0.65-2.27, P = .54, acute HF: adjusted HR 1.78, 95% CI 1.03-3.08, P = .04). There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF; however, among patients with acute HF, there were numerically fewer events with apixaban than placebo (14.8 vs 19.3, HR 0.76, 95% CI 0.57-1.01, interaction P = .13), a trend that was not seen in patients with prior HF or no HF. In high-risk patients post-ACS, both prior and acute HFs are associated with an increased risk of subsequent clinical events. Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF; however, there was a tendency toward fewer clinical events with apixaban in patients with acute HF. Copyright © 2015 Elsevier Inc. All rights reserved.

Thromboembolic and Major Bleeding Events With Rivaroxaban Versus Warfarin Use in a Real-World Setting.

PubMed

Russo-Alvarez, Giavanna; Martinez, Kathryn A; Valente, Megan; Bena, James; Hu, Bo; Luxenburg, Jennifer; Chaitoff, Alexander; Ituarte, Catherine; Brateanu, Andrei; Rothberg, Michael B

2018-01-01

Although randomized trials demonstrate the noninferiority of rivaroxaban compared with warfarin in the context of nonvalvular atrial fibrillation (AF), little is known about how these drugs compare in practice. To assess the relative effectiveness and safety of rivaroxaban versus warfarin in a large health system and to evaluate this association by time in therapeutic range (TTR). We conducted a retrospective cohort study with propensity matching in the Cleveland Clinic Health System. The study included patients initiated on warfarin or rivaroxaban for thromboembolic prevention in nonvalvular AF between January 2012 and July 2016. The main outcomes were thromboembolic events and major bleeds. Analyses were stratified by warfarin patients' TTR. The cohort consisted of 472 propensity-matched pairs. The mean age was 73.6 years (SD = 11.7), and the mean CHADS 2 score was 1.8. The median TTR for warfarin patients was 64%. In the propensity-matched analysis, there was no significant difference in thromboembolic or major bleeding events between groups. Among warfarin patients with a TTR <64% and their matched rivaroxaban pairs, there was also no significant difference in thromboembolic or major bleeding events. Under real-world conditions, warfarin and rivaroxaban were associated with similar safety and effectiveness, even among those with suboptimal therapeutic control. Individualized decision making, taking into account the nontherapeutic tradeoffs associated with these medications (eg, monitoring, half-life, cost) is warranted.

[Massive hemorrhage of upper gastrointestinal tract caused by gastrointestinal stromal tumor of the stomach--case report].

PubMed

Lalović, Nenad; Dukić Vladicić, Nikolina; Marić, Radmil; Cuk, Mirjana; Simatović, Milan; Jokanović, Dragana

2012-01-01

Acute bleeding from the upper gastrointestinal system is a medical emergency which is followed by high mortality rate, ranging from 6 to 15% in spite of modern diagnostic methods and treatment. Bleeding from the upper gastrointestinal system may be caused by gastrointestinal stromal tumors of the stomach, which are mainly characterized by occult bleeding, while profuse bleeding rarely occurs accompanied by hemorrhagic shock. Gastrointestinal stromal tumors of stomach are the most common mesenchimal tumors of the gastrointestinal tract. In our study we showed a 60-year-old female patient with profuse bleeding from the stomach and the clinical picture of severe hemorrhagic shock, caused by gastrointestinal stromal tumor. An ovoid junction, raised towards the lumen, covered with ulcerated mucosa in several places and followed by massive arterial bleeding was found intraoperatively, after the performed gastrotomy. Histopathological examination with immunohistochemical analysis confirmed that this was a gastrointestinal stromal tumor of the stomach. Acute bleeding from the digestive system is a sudden and serious condition of the body. Urgent esophagogastroduodenoscopy is a sensitive and specific diagnostic and therapeutic method of choice. Massive bleeding from the upper gastrointestinal tract is very rarely caused by gastrointestinal stromal tumors, whose clinical picture is very heterogeneous and depends on tumor size and location. Abundant bleeding from the tumor is an indication for urgent surgical intervention. According to the literature massive hemorrhage of the upper digestive system can rarely be caused by gastrointestinal stromal tumor of the stomach. It is shown that abundant hemorrhage of the upper digestive tract can be caused with gastric gastrointestinal stromal tumor. Surgical resection is the main form of treatment of gastrointestinal stromal tumors of the digestive system and bleeding from these tumors caused by failure of endoscopic hemostasis.

A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives.

PubMed

Modesto, Waleska; Bahamondes, M Valeria; Bahamondes, Luis

2014-07-01

Does intensive counselling before insertion and throughout the first year of use have any influence on discontinuation rates due to unpredictable menstrual bleeding in users of three long-acting reversible contraceptives (LARCs)? Intensive counselling had a similar effect to routine counselling in terms of discontinuation rates due to unpredictable menstrual bleeding in new users of the contraceptives. Contraceptive efficacy and satisfaction rates are very high with LARCs, including the etonogestrel (ENG)-releasing implant, the levonorgestrel-releasing intrauterine system (LNG-IUS) and the TCu380A intrauterine device (IUD). However, unpredictable menstrual bleeding constitutes the principal reason for premature discontinuation, particularly in the cases of the ENG-implant and the LNG-IUS. A randomized clinical trial was conducted between 2011 and 2013, and involved 297 women: 98 ENG-implant users, 99 LNG-IUS users and 100 TCu380A IUD users. Women accepting each contraceptive method were randomized into two groups after the women chose their contraceptive method. Group I received routine counselling at the clinic, including information on safety, efficacy and side effects, as well as what to expect regarding bleeding disturbances. Group II received 'intensive counselling'. In addition to the information provided to those in Group I, these women also received leaflets on their chosen method and were seen by the same three professionals, the most experienced at the clinic, throughout the year of follow-up. These three professionals went over all the information provided at each consultation. Women in both groups were instructed to return to the clinic after 45 (±7) days and at 6 and 12 (±1) months after insertion. They were instructed to record all bleeding episodes on a menstrual calendar specifically provided for this purpose. Additionally, satisfaction with the method was evaluated by a questionnaire completed by the women after 12 months of use of the contraceptive method. There were no significant differences between the intensive and routine counselling groups on the discontinuation rates due to unpredictable menstrual bleeding of the three contraceptives under evaluation. The 1-year cumulative discontinuation rates due to menstrual bleeding irregularities were 2.1, 2.7 and 4.0% and the continuation rates were 82.6, 81.0 and 73.2%, for the ENG-implant, the LNG-IUS or the TCu380A IUD users, respectively. The main reasons for discontinuation of the methods were weight gain in users of the ENG-implant and expulsion of the TCu380A. The main limitations are that we cannot assure generalization of the results to another settings and that the routine counselling provided by our counsellors may already be appropriate for the women attending the clinic and so consequently intensive counselling including written leaflets was unable to influence the premature discontinuation rate due to unpredictable menstrual bleeding. Additionally, counselling could discourage some women from using the LARC methods offered in the study and consequently those women may have decided on other contraceptives. Routine counselling may be sufficient for many women to help reduce premature discontinuation rates and improve continuation rates and user satisfaction among new users of LARC methods. The trial was registered at clinicaltrials.gov (NCT01392157). The study was partially funded by the Fundação de Apoio a Pesquisa do Estado de São Paulo (FAPESP) grant # 2012/01379-0, the Brazilian National Research Council (CNPq) grant #573747/2008-3 and by Merck (MSD), Brazil under an unrestricted grant. The LNG-IUS were donated by the International Contraceptive Access Foundation (ICA) and the copper IUD by Injeflex, São Paulo, Brazil. L.B. has occasionally served on the Board of MSD, Bayer and Vifor.

Application of Absorbable Hemostatic Materials Observed in Thyroid Operation

NASA Astrophysics Data System (ADS)

Li, Yan-Ming; Liang, Zhen-Zhen; Song, Yan

2016-05-01

To observe the application effects of the absorbable hemostatic materials in thyroid operation. Methods: From May 2014 to January 2015, 100 patients with thyroid surgery in our university affiliated hospital were selected as the research object. Randomly divided into experimental group and control group, 50 cases in each group. Application of absorbable hemostatic hemostatic materials in the experimental group during the operation, the control group using the traditional mechanical methods of hemostasis hemostasis to observe the operation time, bleeding volume, postoperative drainage volume, complications and hospital stay of the two groups. Results: The operation time, bleeding volume, postoperative drainage and hospital stay in the experimental group were significantly lower in the study group than in the control group, and the difference between the two groups was statistically significant (P< 0.05); The satisfaction of patients in the experimental group was significantly higher than that in the control group, the difference was statistically significant in the two groups (P < 0.05); There was no significant difference in the incidence of wound bleeding complications between the study group and the control group (P > 0.05). Conclusion: Absorbable hemostatic materials can effectively shorten the operation time, reduce intraoperative blood loss and postoperative drainage, reduce the length of hospital stay and improve the success rate of surgery and patient satisfaction, which is worthy to be popularized in clinical thyroid surgery.

Clinical Features of and Risk Factors for Fatal Ebola Virus Disease, Moyamba District, Sierra Leone, December 2014-February 2015.

PubMed

Haaskjold, Yngvar Lunde; Bolkan, Håkon Angell; Krogh, Kurt Østhuus; Jongopi, James; Lundeby, Karen Marie; Mellesmo, Sindre; Garcés, Pedro San José; Jøsendal, Ola; Øpstad, Åsmund; Svensen, Erling; Fuentes, Luis Matias Zabala; Kamara, Alfred Sandy; Riera, Melchor; Arranz, Javier; Roberts, David P; Stamper, Paul D; Austin, Paula; Moosa, Alfredo J; Marke, Dennis; Hassan, Shoaib; Eide, Geir Egil; Berg, Åse; Blomberg, Bjørn

2016-09-01

The 2013-2016 outbreak of Ebola virus disease (EVD) in West Africa infected >28,000 people, including >11,000 who died, and disrupted social life in the region. We retrospectively studied clinical signs and symptoms and risk factors for fatal outcome among 31 Ebola virus-positive patients admitted to the Ebola Treatment Center in Moyamba District, Sierra Leone. We found a higher rate of bleeding manifestations than reported elsewhere during the outbreak. Significant predictors for death were shorter time from symptom onset to admission, male sex, high viral load on initial laboratory testing, severe pain, diarrhea, bloody feces, and development of other bleeding manifestations during hospitalization. These risk factors for death could be used to identify patients in need of more intensive medical support. The lack of fever in as many as one third of EVD cases may have implications for temperature-screening practices and case definitions.

The relationship between volatile sulphur compounds, tongue coating and periodontal disease.

PubMed

Calil, C; Liberato, F L; Pereira, A C; de Castro Meneghim, M; Goodson, J M; Groppo, F C

2009-11-01

The purpose of the present study was to observe the casual levels of volatile sulphur compounds (VSC) in volunteers with different clinical scores of tongue coating, periodontal pockets depth and Gingival Bleeding Index. Seventy-two subjects who attended for the first time at the dental clinic of the University were randomly selected for intra-oral and periodontal examinations. Systemic and dental histories were also obtained. The subjects were unaware of all procedures. The level of VSC was assessed by using a portable sulphide monitor (Halimeter; Interscan Co., Chatsworth, CA, USA). High tongue coating levels were related with more VSC counts (multivariate anova, P = 0.01). No statistically significant relation (multiple linear regression, P > 0.05) was observed among the VSC levels considering age, bleeding and periodontal pockets sites (depth > 4 mm). We concluded that the tongue coating was one of the main factors influencing the VSC levels.

Portal hypertension and gastrointestinal bleeding: Diagnosis, prevention and management

PubMed Central

Biecker, Erwin

2013-01-01

Bleeding from esophageal varices is a life threatening complication of portal hypertension. Primary prevention of bleeding in patients at risk for a first bleeding episode is therefore a major goal. Medical prophylaxis consists of non-selective beta-blockers like propranolol or carvedilol. Variceal endoscopic band ligation is equally effective but procedure related morbidity is a drawback of the method. Therapy of acute bleeding is based on three strategies: vasopressor drugs like terlipressin, antibiotics and endoscopic therapy. In refractory bleeding, self-expandable stents offer an option for bridging to definite treatments like transjugular intrahepatic portosystemic shunt (TIPS). Treatment of bleeding from gastric varices depends on vasopressor drugs and on injection of varices with cyanoacrylate. Strategies for primary or secondary prevention are based on non-selective beta-blockers but data from large clinical trials is lacking. Therapy of refractory bleeding relies on shunt-procedures like TIPS. Bleeding from ectopic varices, portal hypertensive gastropathy and gastric antral vascular ectasia-syndrome is less common. Possible medical and endoscopic treatment options are discussed. PMID:23964137

Control of traumatic wound bleeding by compression with a compact elastic adhesive dressing.

PubMed

Naimer, Sody Abby; Tanami, Menachem; Malichi, Avishai; Moryosef, David

2006-07-01

Compression dressing has been assumed effective, but never formally examined in the field. A prospective interventional trial examined efficacy and feasibility of an elastic adhesive dressing compression device in the arena of the traumatic incident. The primary variable examined was the bleeding rate from wounds compared before and after dressing. Sixty-two consecutive bleeding wounds resulting from penetrating trauma were treated. Bleeding intensity was profuse in 58%, moderate 23%, and mild in 19%. Full control of bleeding was achieved in 87%, a significantly diminished rate in 11%, and, in 1 case, the technique had no influence on the bleeding rate. The Wilcoxon test for variables comparing bleeding rates before and after the procedure obtained significant difference (Z = -6.9, p < 0.01). No significant complications were observed. Caregivers were highly satisfied in 90% of cases. Elastic adhesive dressing was observed as an effective and reliable technique, demonstrating a high rate of success without complications.

Azithromycin buccal patch in treatment of chronic periodontitis.

PubMed

Latif, Sajith Abdul; Vandana, K L; Thimmashetty, J; Dalvi, Priyanka Jairaj

2016-01-01

This study aims to explore the clinical, microbiological, and biochemical impact of azithromycin (AZM) buccal patch in chronic generalized patients as a monotherapy as well as an adjunct to nonsurgical therapy. A parallel design was used forty periodontitis patients were randomly allocated into five groups, namely Group 1 scaling root planing (SRP) alone, Group 2 (SRP + AZM patch group), Group 3 (SRP + AZM tablet group), Group 4 (AZM patch monotherapy), and Group 5 (AZM tablet as monotherapy). Plaque index, gingival bleeding index, modified gingival index, probing pocket depth (PPD), and clinical attachment level (CAL) were assessed at baseline and 21 and 90 days. Subgingival pooled plaque sample was collected to assess periodontopathogens like Porphyromonas gingivalis and Prevotella intermedia (Pi) by anaerobic culture method. Tumor necrosis factor alpha (TNF-α) was also evaluated at baseline and 21 days. Periodontal maintenance was performed in Group 1 until 90(th) day, and clinical parameter was assessed at the end of 90(th) day. SRP + AZM tablets showed greater reduction in clinical parameters (P < 0.05) AZM as monotherapy did not offer clinical benefits over SRP. Baseline data were compared at the end, i.e., 90(th) day a significant reduction in plaque scores, gingival bleeding, and PPD was observed however no significant gain in the clinical attachment was observed. The monotherapy resulted in no improvement of periodontal parameters, microbial parameters, and TNF-α level. It is safe to use AZM + SRP as a mode of nonsurgical treatment in periodontitis patients.

Azithromycin buccal patch in treatment of chronic periodontitis

PubMed Central

Latif, Sajith Abdul; Vandana, K. L.; Thimmashetty, J.; Dalvi, Priyanka Jairaj

2016-01-01

Aim: This study aims to explore the clinical, microbiological, and biochemical impact of azithromycin (AZM) buccal patch in chronic generalized patients as a monotherapy as well as an adjunct to nonsurgical therapy. Materials and Methods: A parallel design was used forty periodontitis patients were randomly allocated into five groups, namely Group 1 scaling root planing (SRP) alone, Group 2 (SRP + AZM patch group), Group 3 (SRP + AZM tablet group), Group 4 (AZM patch monotherapy), and Group 5 (AZM tablet as monotherapy). Plaque index, gingival bleeding index, modified gingival index, probing pocket depth (PPD), and clinical attachment level (CAL) were assessed at baseline and 21 and 90 days. Subgingival pooled plaque sample was collected to assess periodontopathogens like Porphyromonas gingivalis and Prevotella intermedia (Pi) by anaerobic culture method. Tumor necrosis factor alpha (TNF-α) was also evaluated at baseline and 21 days. Periodontal maintenance was performed in Group 1 until 90th day, and clinical parameter was assessed at the end of 90th day. Results: SRP + AZM tablets showed greater reduction in clinical parameters (P < 0.05) AZM as monotherapy did not offer clinical benefits over SRP. Baseline data were compared at the end, i.e., 90th day a significant reduction in plaque scores, gingival bleeding, and PPD was observed however no significant gain in the clinical attachment was observed. Conclusion: The monotherapy resulted in no improvement of periodontal parameters, microbial parameters, and TNF-α level. It is safe to use AZM + SRP as a mode of nonsurgical treatment in periodontitis patients. PMID:27127325

Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

PubMed

Krag, Mette; Perner, Anders; Wetterslev, Jørn; Wise, Matt P; Hylander Møller, Morten

2014-01-01

To assess the effects of stress ulcer prophylaxis (SUP) versus placebo or no prophylaxis on all-cause mortality, gastrointestinal (GI) bleeding and hospital-acquired pneumonia in adult critically ill patients in the intensive care unit (ICU). We performed a systematic review using meta-analysis and trial sequential analysis (TSA). Eligible trials were randomised clinical trials comparing proton pump inhibitors or histamine 2 receptor antagonists with either placebo or no prophylaxis. Two reviewers independently assessed studies for inclusion and extracted data. The Cochrane Collaboration methodology was used. Risk ratios/relative risks (RR) with 95% confidence intervals (CI) were estimated. The predefined outcome measures were all-cause mortality, GI bleeding, and hospital-acquired pneumonia. Twenty trials (n = 1,971) were included; all were judged as having a high risk of bias. There was no statistically significant difference in mortality (fixed effect: RR 1.00, 95% CI 0.84-1.20; P = 0.87; I(2) = 0%) or hospital-acquired pneumonia (random effects: RR 1.23, 95% CI 0.86-1.78; P = 0.28; I(2) = 19%) between SUP patients and the no prophylaxis/placebo patients. These findings were confirmed in the TSA. With respect to GI bleeding, a statistically significant difference was found in the conventional meta-analysis (random effects: RR 0.44, 95% CI 0.28-0.68; P = 0.01; I(2) = 48%); however, TSA (TSA adjusted 95% CI 0.18-1.11) and subgroup analyses could not confirm this finding. This systematic review using meta-analysis and TSA demonstrated that both the quality and the quantity of evidence supporting the use of SUP in adult ICU patients is low. Consequently, large randomised clinical trials are warranted.

Prevalence of Periodontal Diseases in a Multicenter Cohort of Perinatally HIV-Infected and HIV-exposed and Uninfected Youth

PubMed Central

Ryder, Mark I.; Yao, Tzy-Jyun; Russell, Jonathan S.; Moscicki, Anna-Barbara; Shiboski, Caroline H.

2016-01-01

Aims To compare the prevalence and severity of periodontal diseases between 180 perinatally HIV-infected (PHIV) and 118 perinatally HIV-exposed and uninfected (PHEU) youth in a cross-sectional study conducted at 11 clinical sites in the United States and Puerto Rico from the Adolescent Master Protocol (AMP) study of the Pediatric HIV/AIDS cohort study (PHACS) network. Methods Several analyses were conducted, employing the current CDC/AAP classification for periodontitis and incorporating a definition of gingivitis based on a bleeding on probing threshold, and analyses based on more detailed whole mouth, intraoral regionally, site-based, and tooth-based criteria of bleeding on probing, plaque levels, pockets depths and clinical attachment levels. Results After adjusting for plaque control habits, and behavioral and sociodemographic factors, there were no significant differences in periodontal diseases between the PHIV and PHEU youth using any of these criteria. For PHIV youth, there was no significant association between parameters of periodontal disease and current HIV status. Conclusions While no significant differences in periodontal parameters were noted between the PHIV and PHEU youth, the influence of antiretroviral therapy on merits further exploration in this cohort in a longitudinal study. PMID:27801947

Effect of posterior crown margin placement on gingival health.

PubMed

Reitemeier, Bernd; Hänsel, Kristina; Walter, Michael H; Kastner, Christian; Toutenburg, Helge

2002-02-01

The clinical impact of posterior crown margin placement on gingival health has not been thoroughly quantified. This study evaluated the effect of posterior crown margin placement with multivariate analysis. Ten general dentists reviewed 240 patients with 480 metal-ceramic crowns in a prospective clinical trial. The alloy was randomly selected from 2 high gold, 1 low gold, and 1 palladium alloy. Variables were the alloy used, oral hygiene index score before treatment, location of crown margins at baseline, and plaque index and sulcus bleeding index scores recorded for restored and control teeth after 1 year. The effect of crown margin placement on sulcular bleeding and plaque accumulation was analyzed with regression models (P<.05). The probability of plaque at 1 year increased with increasing oral hygiene index score before treatment. The lingual surfaces demonstrated the highest probability of plaque. The risk of bleeding at intrasulcular posterior crown margins was approximately twice that at supragingival margins. Poor oral hygiene before treatment and plaque also were associated with sulcular bleeding. Facial sites exhibited a lower probability of sulcular bleeding than lingual surfaces. Type of alloy did not influence sulcular bleeding. In this study, placement of crown margins was one of several parameters that affected gingival health.

Coil-Assisted Retrograde Transvenous Obliteration (CARTO) for the Treatment of Portal Hypertensive Variceal Bleeding: Preliminary Results

PubMed Central

Lee, Edward W; Saab, Sammy; Gomes, Antoinette S; Busuttil, Ronald; McWilliams, Justin; Durazo, Francisco; Han, Steven-Huy; Goldstein, Leonard; Tafti, Bashir A; Moriarty, John; Loh, Christopher T; Kee, Stephen T

2014-01-01

OBJECTIVES: To describe the technical feasibility, safety, and clinical outcomes of coil-assisted retrograde transvenous obliteration (CARTO) in treating portal hypertensive non-esophageal variceal hemorrhage. METHODS: From October 2012 to December 2013, 20 patients who received CARTO for the treatment of portal hypertensive non-esophageal variceal bleeding were retrospectively evaluated. All 20 patients had at least 6-month follow-up. All patients had detachable coils placed to occlude the efferent shunt and retrograde gelfoam embolization to achieve complete thrombosis/obliteration of varices. Technical success, clinical success, rebleeding, and complications were evaluated at follow-up. RESULTS: A 100% technical success rate (defined as achieving complete occlusion of efferent shunt with complete thrombosis/obliteration of bleeding varices and/or stopping variceal bleeding) was demonstrated in all 20 patients. Clinical success rate (defined as no variceal rebleeding) was 100%. Follow-up computed tomography after CARTO demonstrated decrease in size with complete thrombosis and disappearance of the varices in all 20 patients. Thirteen out of the 20 had endoscopic confirmation of resolution of varices. Minor post-CARTO complications, including worsening of esophageal varices (not bleeding) and worsening of ascites/hydrothorax, were noted in 5 patients (25%). One patient passed away at 24 days after the CARTO due to systemic and portal venous thrombosis and multi-organ failure. Otherwise, no major complication was noted. No variceal rebleeding was noted in all 20 patients during mean follow-up of 384±154 days. CONCLUSIONS: CARTO appears to be a technically feasible and safe alternative to traditional balloon-occluded retrograde transvenous obliteration or transjugular intrahepatic portosystemic shunt, with excellent clinical outcomes in treating portal hypertensive non-esophageal variceal bleeding. PMID:25273155

The risk of venous thromboembolism, myocardial infarction, stroke, major bleeding and death in patients undergoing total hip and knee replacement: a 15-year retrospective cohort study of routine clinical practice.

PubMed

Pedersen, A B; Mehnert, F; Sorensen, H T; Emmeluth, C; Overgaard, S; Johnsen, S P

2014-04-01

We examined the risk of thrombotic and major bleeding events in patients undergoing total hip and knee replacement (THR and TKR) treated with thromboprophylaxis, using nationwide population-based databases. We identified 83 756 primary procedures performed between 1997 and 2011. The outcomes were symptomatic venous thromboembolism (VTE), myocardial infarction (MI), stroke, death and major bleeding requiring hospitalisation within 90 days of surgery. A total of 1114 (1.3%) and 483 (0.6%) patients experienced VTE and bleeding, respectively. The annual risk of VTE varied between 0.9% and 1.6%, and of bleeding between 0.4% and 0.8%. The risk of VTE and bleeding was unchanged over a 15-year period. A total of 0.7% of patients died within 90 days, with a decrease from 1% in 1997 to 0.6% in 2011 (p < 0.001). A high level of comorbidity and general anaesthesia were strong risk factors for both VTE and bleeding, with no difference between THR and TKR patients. The risk of both MI and stroke was 0.5%, which remained unchanged during the study period. In this cohort study of patients undergoing THR and TKR patients in routine clinical practice, approximately 3% experienced VTE, MI, stroke or bleeding. These risks did not decline during the 15-year study period, but the risk of dying fell substantially.

Primary aortoduodenal fistula associated with abdominal aortic aneurysm with presentation of gastrointestinal bleeding: a case report.

PubMed

Lin, Tzu-Chieh; Tsai, Chung-Lin; Chang, Yao-Tien; Hu, Sung-Yuan

2018-06-07

Primary aortoduodenal fistula (ADF) is a rare cause of gastrointestinal (GI) bleeding and is difficult to diagnose as the clinical presentation is subtle. Clinicians should keep a high level of suspicion for an unknown etiology of GI bleeding, especially in older patients with or without abdominal aortic aneurysm (AAA). Computed tomographic angiography (CTA) can be used to detect primary ADF. Open surgery or endovascular aortic repair (EVAR) for ADF with bleeding will improve the survival rate. We report a rare case of AAA complicating ADF with massive GI bleeding in a 73-year-old Taiwanese man. He presented with abdominal pain and tarry stool for 5 days and an initial upper GI endoscopy at a rural hospital showed gastric ulcer only, but hypotension with tachycardia and a drop in hemoglobin of 9 g/dl from 12 g/dl occurred the next day. He was referred to our hospital for EVAR and primary closure of fistula defect due to massive GI bleeding with shock from ADF caused by AAA. Diagnosis was made by CTA of aorta. A timely and accurate diagnosis of primary ADF may be challenging due to insidious episodes of GI bleeding, which are frequently under-diagnosed until the occurrence of massive hemorrhage. Clinical physicians should keep a high index of awareness for primary ADF, especially in elderly patients with unknown etiology of upper GI bleeding with or without a known AAA.

Major haemorrhage fatalities in the Australian national coronial database.

PubMed

Gipson, Jacob S; Wood, Erica M; Cole-Sinclair, Merrole F; McQuilten, Zoe; Waters, Neil; Woodford, Noel W

2017-12-10

The aim of the study is to describe the epidemiology of major bleeding fatalities. A case series analysis of Australia's National Coronial Information System was conducted. Keywords were used to search for closed cases of major haemorrhage in the state of Victoria for the period 1 January 2009 to 31 December 2011. Coroners' findings, autopsy reports and police reports of cases were reviewed. Demographic data were extracted, and cases were assigned to a clinical bleeding context. A total of 427 cases of major bleeding causing death were identified. The cohort was predominately men (69%), with a median age of 63 years (interquartile range 45-77 years). Trauma accounted for 38%, gastrointestinal haemorrhage 28%, surgical/procedural bleeding 14%, ruptured/leaking aneurysms 12% and other 8%. Most events began in homes (46%), hospitals (22%) and at the roadside (17%). Of those whose haemorrhage began in the community, 69% did not survive to hospital. Major bleeding fatalities occurred across a diverse range of contexts, with trauma and gastrointestinal bleeding accounting for most deaths. The majority of patients did not survive to reach hospital. Major haemorrhage occurring entirely outside hospital may be underrecognised from analyses of datasets based primarily on traumatic or in-hospital bleeding. These findings have implications for management of pre-hospital resuscitation and development of clinical practice guidelines for identification and management of major bleeding in the community. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Clopidogrel bisulfate (Plavix) does not increase bleeding complications in patients undergoing rubber band ligation for symptomatic hemorrhoids.

PubMed

Hite, Nathan; Klinger, Aaron L; Miller, Peter; Beck, David E; Whitlow, Charles B; Hicks, Terry C; Green, Heather M; Margolin, David A

2018-09-01

The incidence of postprocedural bleeding in patients undergoing rubber band ligation (RBL) for symptomatic internal hemorrhoids while taking clopidogrel bisulfate is unknown. To determine the postprocedural bleeding risk of RBL for patients taking clopidogrel compared with age- and sex-matched controls. This is a retrospective case-controlled cohort study analyzing data from 2005 to 2013 conducted at a single tertiary care academic center. The study included a total of 80 rubber bands placed on 41 patients taking clopidogrel bisulfate and 72 bands placed on 41 control patients not taking clopidogrel matched for age and sex. The 30-d rates of significant and insignificant bleeding events after RBL were recorded. A bleeding event was considered significant if the patient required admission to the hospital, transfusion of blood products, or additional procedures to stop the bleeding. Insignificant bleeding was defined as passage of blood or clots per rectum with spontaneous cessation and no need for additional intervention. There was no significant difference in the number of bleeding events per band placed in the clopidogrel group when compared with the control group (3.75% versus 2.78%, P = 0.7387). The rate of significant (2.5% versus 1.39%, P = 0.6244) and insignificant bleeding events (1.25% versus 1.39%, P = 0.9399) was also similar between the two groups. Two significant bleeding events occurred in the clopidogrel group requiring intervention: cauterization in one patient and colonoscopy and transfusion in the other. The risk of a bleeding complication after RBL for hemorrhoids does not appear to be increased in patients taking clopidogrel. Our results support the practice of continuing clopidogrel bisulfate in the periprocedural period as the associated risk of thrombosis is greater than the risk of bleeding. Copyright © 2018 Elsevier Inc. All rights reserved.

A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

PubMed

Klukowska, Malgorzata; Grender, Julie M; Conde, Erinn; Goyal, C Ram

2013-01-01

The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque (38% and 24% at Weeks 4 and 12, respectively; p < 0.001), gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p < 0.001). Both power toothbrushes were well-tolerated. An advanced oscillating-rotating power toothbrush produced substantial, statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

Clinical periodontal variables in patients with and without dementia-a systematic review and meta-analysis.

PubMed

Maldonado, Alejandra; Laugisch, Oliver; Bürgin, Walter; Sculean, Anton; Eick, Sigrun

2018-06-22

Considering the increasing number of elderly people, dementia has gained an important role in today's society. Although the contributing factors for dementia have not been fully understood, chronic periodontitis (CP) seems to have a possible link to dementia. To conduct a systematic review including meta-analysis in order to assess potential differences in clinical periodontal variables between patients with dementia and non-demented individuals. The following focused question was evaluated: is periodontitis associated with dementia? Electronic searches in two databases, MEDLINE and EMBASE, were conducted. Meta-analysis was performed with the collected data in order to find a statistically significant difference in clinical periodontal variables between the group of dementia and the cognitive normal controls. Forty-two articles remained for full text reading. Finally, seven articles met the inclusion criteria and only five studies provided data suitable for meta-analysis. Periodontal probing depth (PPD), bleeding on probing (BOP), gingival bleeding index (GBI), clinical attachment level (CAL), and plaque index (PI) were included as periodontal variables in the meta-analysis. Each variable revealed a statistically significant difference between the groups. In an attempt to reveal an overall difference between the periodontal variables in dementia patients and non-demented individuals, the chosen variables were transformed into units that resulted in a statistically significant overall difference (p < 0.00001). The current findings indicate that compared to systemically healthy individuals, demented patients show significantly worse clinical periodontal variables. However, further epidemiological studies including a high numbers of participants, the use of exact definitions both for dementia and chronic periodontitis and adjusted for cofounders is warranted. These findings appear to support the putative link between CP and dementia. Consequently, the need for periodontal screening and treatment of elderly demented people should be emphasized.

Meta-analysis of gender differences in residual stroke risk and major bleeding in patients with nonvalvular atrial fibrillation treated with oral anticoagulants.

PubMed

Pancholy, Samir B; Sharma, Parikshit S; Pancholy, Dipti S; Patel, Tejas M; Callans, David J; Marchlinski, Francis E

2014-02-01

Studies comparing gender-specific outcomes in patients with atrial fibrillation (AF) have reported conflicting results. Gender differences in cerebrovascular accident/systemic embolism (CVA/SE) or major bleeding outcomes with novel oral anticoagulant (NOAC) use are not known. The goal of this analysis was to perform a systematic review and meta-analysis evaluating gender differences in residual risk of CVA/SE and major bleeding outcomes in patients with nonvalvular AF treated with either warfarin or NOAC. Sixty-four randomized studies were identified using keywords "gender," "AF," and "CVA." Using the Preferred Reporting Items for Systemic Reviews and Meta-analysis method, 6 studies met criteria for inclusion in this meta-analysis. CVA/SE and major bleeding outcomes were separately analyzed in cohorts receiving warfarin and NOAC agents, comparing men with women. Women with AF taking warfarin were at a significantly greater residual risk of CVA/SE compared with men (odds ratio 1.279, 95% confidence interval 1.111 to 1.473, Z = -3.428, p = 0.001). No gender difference in residual risk of CVA/SE was noted in patients with AF receiving NOAC agents (odds ratio 1.146, 95% confidence interval 0.97 to 1.354, p = 0.109). Major bleeding was less frequent in women with AF treated with NOAC. In conclusion, women with AF treated with warfarin have a greater residual risk of CVA/SE and an equivalent major bleeding risk, whereas those treated with NOAC agents deemed superior to warfarin are at equivalent residual risk of CVA/SE and less major bleeding risk compared with men. These results suggest an increased net clinical benefit of NOAC agents compared with warfarin in treating women with AF. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of a Low-Dose Contraceptive Patch on Efficacy, Bleeding Pattern, and Safety

PubMed Central

Wiegratz, Inka; Bassol, Susana; Weisberg, Edith; Mellinger, Uwe

2014-01-01

This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD. Participants were women aged 18 to 35 years, all of whom received the EE/GSD patch for 13 cycles each of 21 treatment days (one patch per week for 3 weeks) followed by a 7-day, patch-free interval. The primary efficacy variable was the occurrence of unintended pregnancies during the study period as assessed by life table analysis and the Pearl Index. Secondary efficacy variables were days with bleeding during four 90-day reference periods and during 1 treatment year, bleeding pattern, and cycle control. The Kaplan-Meier probability of contraceptive protection after 364 treatment days was 98.8% and the adjusted Pearl Index was 0.81. The percentage of participants with intracyclic bleeding/spotting decreased over time, from 11.4% to 6.8% in cycles 1 and 12, respectively. Almost all participants (range: 90.8%-97.6%) experienced withdrawal bleeding across the study period. Compliance was very high (mean: 97.9%; median: 100%). The most frequent adverse events were headache (9.5%) and application site reaction (8.5%); no clinically significant safety concerns were observed. Results suggest the EE/GSD patch is highly effective in preventing pregnancy. Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population. The patch was well tolerated and treatment compliance was high. PMID:24784719

Risk Factors for Post-TAVI Bleeding According to the VARC-2 Bleeding Definition and Effect of the Bleeding on Short-Term Mortality: A Meta-analysis.

PubMed

Wang, Jiayang; Yu, Wenyuan; Jin, Qi; Li, Yaqiong; Liu, Nan; Hou, Xiaotong; Yu, Yang

2017-04-01

In this study we investigated the effect of post-transcatheter aortic valve implantation (TAVI) bleeding (per Valve Academic Research Consortium-2 [VARC-2] bleeding criteria) on 30-day postoperative mortality and examined the correlation between pre- or intraoperative variables and bleeding. Multiple electronic literature databases were searched using predefined criteria, with bleeding defined per Valve Academic Research Consortium-2 criteria. A total of 10 eligible articles with 3602 patients were included in the meta-analysis. The meta-analysis revealed that post-TAVI bleeding was associated with a 323% increase in 30-day postoperative mortality (odds risk [OR]; 4.23, 95% confidence interval [CI], 2.80-6.40; P < 0.0001) without significant study heterogeneity or publication bias. In subgroup analysis we found that patients with major bleeding/life-threatening bleeding showed a 410% increase in mortality compared with patients without bleeding (OR, 5.10; 95% CI, 3.17-8.19; P < 0.0001). Transapical access was associated with an 83% increase in the incidence of bleeding compared with transfemoral access (OR, 1.83; 95% CI, 1.43-2.33; P < 0.0001). Multiple logistic regression analysis revealed that atrial fibrillation (AF) was independently correlated with TAVI-associated bleeding (OR, 2.63; 95% CI, 1.33-5.21; P = 0.005). Meta-regression showed that potential modifiers like the Society of Thoracic Surgeons (STS) score, mortality, the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), aortic valve area, mean pressure gradient, left ventricular ejection fraction, preoperative hemoglobin and platelet levels, and study design had no significant effects on the results of the meta-analysis. Post-TAVI bleeding, in particular, major bleeding/life-threatening bleeding, increased 30-day postoperative mortality. Transapical access was a significant bleeding risk factor. Preexisting AF independently correlated with TAVI-associated bleeding, likely because of AF-related anticoagulation. Recognition of the importance and determinants of post-TAVI bleeding should lead to strategies to improve outcomes. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Dabigatran and kidney disease: a bad combination.

PubMed

Knauf, Felix; Chaknos, C Michael; Berns, Jeffrey S; Perazella, Mark A

2013-09-01

Dabigatran is an oral direct thrombin inhibitor widely used to prevent and treat various thromboembolic complications. An advantage of this agent over other anticoagulants is that routine laboratory monitoring and related dose adjustments are considered unnecessary. A major disadvantage is the absence of a reliable means of reversing its anticoagulant effect. After U.S. Food and Drug Administration approval, recently emerged data suggest a higher bleeding risk with dabigatran, especially in the elderly. Clinicians are thus faced with caring for patients with serious bleeding events without readily available tests to measure drug levels or the anticoagulant effects of dabigatran and without effective antidotes to rapidly reverse the anticoagulant effect. On the basis of dabigatran's pharmacokinetic profile, hemodialysis and continuous renal replacement therapy have been used to remove dabigatran with the hope, still unproven, that this would rapidly reverse the anticoagulant effect and reduce bleeding in patients with normal and those with reduced kidney function. However, the best clinical approach to the patient with serious bleeding is not known, and the risks of placing a hemodialysis catheter in an anticoagulated patient can be substantial. This article reviews this issue, addressing clinical indications, drug pharmacokinetics, clinical and laboratory monitoring tests, and dialytic and nondialytic approaches to reduce bleeding in dabigatran-treated patients.

The structured menstrual history: developing a tool to facilitate diagnosis and aid in symptom management.

PubMed

Matteson, Kristen A; Munro, Malcolm G; Fraser, Ian S

2011-09-01

Abnormal uterine bleeding (AUB) is a prevalent symptom that encompasses abnormalities in menstrual regularity, duration, frequency and/or volume, and it is encountered frequently by both primary care physicians and obstetrician-gynecologists. Research on AUB has used numerous methods to measure bleeding and assess symptoms, but the lack of universally accepted outcome measures hinder the quality of research and the ability of clinical investigators to collaborate in multicenter trials. Similarly, clinical care for women reporting heavy, prolonged, or irregular menstrual bleeding is not optimized because standard ways of evaluating symptoms and change in symptoms over time do not exist. This article describes (1) the current methods of evaluating women with AUB, both in research and clinical care; and (2) offers suggestions for the development of a standardized structured menstrual history for use in both research and clinical care. © Thieme Medical Publishers.

Menstrual Patterns and Treatment of Heavy Menstrual Bleeding in Adolescents with Bleeding Disorders.

PubMed

Dowlut-McElroy, Tazim; Williams, Karen B; Carpenter, Shannon L; Strickland, Julie L

2015-12-01

To characterize menstrual bleeding patterns and treatment of heavy menstrual bleeding in adolescents with bleeding disorders. We conducted a retrospective review of female patients aged nine to 21 years with known bleeding disorders who attended a pediatric gynecology, hematology, and comprehensive hematology/gynecology clinic at a children's hospital in a metropolitan area. Prevalence of heavy menstrual bleeding at menarche, prolonged menses, and irregular menses among girls with bleeding disorders and patterns of initial and subsequent treatment for heavy menstrual bleeding in girls with bleeding disorders. Of 115 participants aged nine to 21 years with known bleeding disorders, 102 were included in the final analysis. Of the 69 postmenarcheal girls, almost half (32/69, 46.4%) noted heavy menstrual bleeding at menarche. Girls with von Willebrand disease were more likely to have menses lasting longer than seven days. Only 28% of girls had discussed a treatment plan for heavy menstrual bleeding before menarche. Hormonal therapy was most commonly used as initial treatment of heavy menstrual bleeding. Half (53%) of the girls failed initial treatment. Combination (hormonal and non-hormonal therapy) was more frequently used for subsequent treatment. Adolescents with bleeding disorders are at risk of heavy bleeding at and after menarche. Consultation with a pediatric gynecologist and/or hematologist prior to menarche may be helpful to outline abnormal patterns of menstrual bleeding and to discuss options of treatment in the event of heavy menstrual bleeding. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Acute on chronic gastrointestinal bleeding: a unique clinical entity.

PubMed

Rockey, Don C; Hafemeister, Adam C; Reisch, Joan S

2017-06-01

Gastrointestinal bleeding is defined in temporal-spatial terms-as acute or chronic, and/or by its location in the gastrointestinal tract. Here, we define a distinct type of bleeding, which we have coined 'acute on chronic' gastrointestinal bleeding. We prospectively identified all patients who underwent endoscopic evaluation for any form of gastrointestinal bleeding at a University Hospital. Acute on chronic bleeding was defined as the presence of new symptoms or signs of acute bleeding in the setting of chronic bleeding, documented as iron deficiency anemia. Bleeding lesions were categorized using previously established criteria. We identified a total of 776, 254, and 430 patients with acute, chronic, or acute on chronic bleeding, respectively. In patients with acute on chronic gastrointestinal bleeding, lesions were most commonly identified in esophagus (28%), colon and rectum (27%), and stomach (21%) (p<0.0001 vs locations for acute or chronic bleeding). In those specifically with acute on chronic upper gastrointestinal bleeding (n=260), bleeding was most commonly due to portal hypertensive lesions, identified in 47% of subjects compared with 29% of acute and 25% of chronic bleeders, (p<0.001). In all patients with acute on chronic bleeding, 30-day mortality was less than that after acute bleeding alone (2% (10/430) vs 7% (54/776), respectively, p<0.001). Acute on chronic gastrointestinal bleeding is common, and in patients with upper gastrointestinal bleeding was most often a result of portal hypertensive upper gastrointestinal tract pathology. Reduced mortality in patients with acute on chronic gastrointestinal bleeding compared with those with acute bleeding raises the possibility of an adaptive response. Copyright © 2017 American Federation for Medical Research.

Angiographic evaluation and management of acute gastrointestinal hemorrhage

PubMed Central

Walker, T Gregory; Salazar, Gloria M; Waltman, Arthur C

2012-01-01

Although most cases of acute nonvariceal gastrointestinal hemorrhage either spontaneously resolve or respond to medical management or endoscopic treatment, there are still a significant number of patients who require emergency angiography and transcatheter treatment. Evaluation with noninvasive imaging such as nuclear scintigraphy or computed tomography may localize the bleeding source and/or confirm active hemorrhage prior to angiography. Any angiographic evaluation should begin with selective catheterization of the artery supplying the most likely site of bleeding, as determined by the available clinical, endoscopic and imaging data. If a hemorrhage source is identified, superselective catheterization followed by transcatheter microcoil embolization is usually the most effective means of successfully controlling hemorrhage while minimizing potential complications. This is now well-recognized as a viable and safe alternative to emergency surgery. In selected situations transcatheter intra-arterial infusion of vasopressin may also be useful in controlling acute gastrointestinal bleeding. One must be aware of the various side effects and potential complications associated with this treatment, however, and recognize the high re-bleeding rate. In this article we review the current role of angiography, transcatheter arterial embolization and infusion therapy in the evaluation and management of nonvariceal gastrointestinal hemorrhage. PMID:22468082

A patient-preference cohort study of office versus inpatient uterine polyp treatment for abnormal uterine bleeding.

PubMed

Cooper, Natalie A M; Middleton, Lee; Smith, Paul; Denny, Elaine; Stobert, Lynda; Daniels, Jane; Clark, T Justin

2016-01-01

Uterine polyps can cause abnormal bleeding in women. Conventional practise is to remove them under general anaesthesia but advances in technology have made it possible to perform polypectomy in the office setting. We conducted a patient-preference study to explore women's preferences for treatment setting and to evaluate the effectiveness and treatment experience of women undergoing uterine polypectomy. Three hundred ninety-nine women with abnormal uterine bleeding who were found to have uterine polyps at diagnostic hysteroscopy were recruited. Office polypectomies were performed in office hysteroscopy clinics, and inpatient procedures were undertaken in operating theatres. Three hundred twenty-four of 399 (81 %) expressed a preference for office treatment. There was no difference found between office treatment and inpatient treatment in terms of alleviating abnormal uterine bleeding as assessed by patients and in improving disease-specific quality of life. Acceptability was lower and patient pain scores were significantly higher in the office group. When offered a choice of treatment setting for uterine polypectomy, patients have a preference for office over inpatient treatment. Ambulatory gynaecology services should be available within healthcare systems to meet patient demand.

The "Prometeo" study: online collection of clinical data and outcome of Italian patients with acute nonvariceal upper gastrointestinal bleeding.

PubMed

Del Piano, Mario; Bianco, Maria Antonia; Cipolletta, Livio; Zambelli, Alessandro; Chilovi, Fausto; Di Matteo, Giovanni; Pagliarulo, Michela; Ballarè, Marco; Rotondano, Gianluca

2013-04-01

To implement an online, prospective collection of clinical data and outcome of patients with acute nonvariceal upper gastrointestinal bleeding (UGIB) in Italy ("Prometeo" study). Epidemiology, clinical features, and outcomes of nonvariceal UGIB are mainly known by retrospective studies and are probably changing. Data were collected by 13 Gastrointestinal Units in Italy from June 2006 to June 2007 (phase 1) and from December 2008 to December 2009 (phase 2): an interim analysis of data was performed between the 2 phases to optimize the online database. All the patients consecutively admitted for acute nonvariceal UGIB were enrolled. Demographic and clinical data were collected, a diagnostic endoscopy performed, with endoscopic hemostasis if indicated. One thousand four hundred thirteen patients (M=932, mean age±SD=66.5±15.8; F=481, mean age±SD=74.2±14.6) were enrolled. Comorbidities were present in 83%. 52.4% were treated with acetyl salicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs): only 13.9% had an effective gastroprotection. Previous episodes of UGIB were present in 13.3%. Transfusion were needed in 43.9%. Shock was present in 9.3%. Endoscopic diagnosis was made in 93.2%: peptic lesions were the main cause of bleeding (duodenal ulcer 36.2%, gastric ulcer 29.6%, gastric/duodenal erosions 10.9%). At endoscopy, Helicobacter pylori was searched in 37.2%, and found positive in 51.3% of tested cases. Early rebleeding was observed in 5.4%: surgery was required in 14.3% of them. Bleeding-related death occurred in 4.0%: at multivariate analysis, the risk of death was correlated with female sex [odds ratio (OR=2.19, P=0.0089)], presence of neoplasia (OR=2.70, P=0.0057) or multiple comorbidities (OR=5.04, P=0.0280), shock at admission (OR=4.55, P=0.0001), and early rebleeding (OR=1.47, P=0.004). Prometeo database has provided an up-to-date picture of acute nonvariceal UGIB in Italy: patients are elderly, predominantly males, and with important comorbidities. Gastroprotection is underutilized during NSAIDs treatment. With respect to previous studies, Prometeo shows a higher incidence of low-dose acetyl salicylic acid use and comorbidities, whereas no significant difference were found in other items (etiology of bleeding, NSAIDs use, need for endoscopic hemostasis, incidence of rebleeding, and overall mortality).

Laser vs bur for bone cutting in impacted mandibular third molar surgery: A randomized controlled trial.

PubMed

Passi, Deepak; Pal, Uma Shankar; Mohammad, Shadab; Singh, Rakesh Kumar; Mehrotra, Divya; Singh, Geeta; Kumar, Manoj; Chellappa, Arul A L; Gupta, Chandan

2013-01-01

The aim of this study was to assess the feasibility of Er: YAG laser in bone cutting for removal of impacted lower third molar teeth and compare its outcomes with that of surgical bur. The study comprised 40 subjects requiring removal of impacted mandibular third molar, randomly categorized into two equal groups of 20 each, who had their impacted third molar removed either using Er: YAG laser or surgical bur as per their group, using standard methodology of extraction of impacted teeth. Clinical parameters like pain, bleeding, time taken for bone cutting, postoperative swelling, trismus, wound healing and complications were compared for both groups. Clinical parameters like pain, bleeding and swelling were lower in laser group than bur group, although the difference was statistically not significant. However, postoperative swelling showed significant difference in the two groups. Laser group required almost double the time taken for bone cutting with bur. Trismus persisted for a longer period in laser group. Wound healing and complications were assessed clinically and there was no significant difference in both the groups. Based on the results of our study, the possibility of bone cutting using lasers is pursued, the osteotomy is easily performed and the technique is better suited to minimally invasive surgical procedures. The use of Er: YAG laser may be considered as an alternative tool to surgical bur, specially in anxious patients.

Periodontitis in coronary heart disease patients: strong association between bleeding on probing and systemic biomarkers.

PubMed

Bokhari, Syed Akhtar H; Khan, Ayyaz A; Butt, Arshad K; Hanif, Mohammad; Izhar, Mateen; Tatakis, Dimitris N; Ashfaq, Mohammad

2014-11-01

Few studies have examined the relationship of individual periodontal parameters with individual systemic biomarkers. This study assessed the possible association between specific clinical parameters of periodontitis and systemic biomarkers of coronary heart disease risk in coronary heart disease patients with periodontitis. Angiographically proven coronary heart disease patients with periodontitis (n = 317), aged >30 years and without other systemic illness were examined. Periodontal clinical parameters of bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL) and systemic levels of high-sensitivity C-reactive protein (CRP), fibrinogen (FIB) and white blood cells (WBC) were noted and analyzed to identify associations through linear and stepwise multiple regression analyses. Unadjusted linear regression showed significant associations between periodontal and systemic parameters; the strongest association (r = 0.629; p < 0.001) was found between BOP and CRP levels, the periodontal and systemic inflammation marker, respectively. Stepwise regression analysis models revealed that BOP was a predictor of systemic CRP levels (p < 0.0001). BOP was the only periodontal parameter significantly associated with each systemic parameter (CRP, FIB, and WBC). In coronary heart disease patients with periodontitis, BOP is strongly associated with systemic CRP levels; this association possibly reflects the potential significance of the local periodontal inflammatory burden for systemic inflammation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical and Immunoinflammatory Evaluation of One-Stage Full-Mouth Ultrasonic Debridement as a Therapeutic Approach for Smokers With Generalized Aggressive Periodontitis: A Short-Term Follow-Up Study.

PubMed

De Genaro Modanese, Danielle; Tiosso-Tamburi, Renato; Furletti de Goes, Vivian Fernandes; de Cássia Bergamaschi, Cristiane; Martinez, Elizabeth Ferreira; Napimoga, Marcelo Henrique; Peruzzo, Daiane Cristina

2016-09-01

This study aims to evaluate the effect of one-stage full-mouth ultrasonic debridement (OSFMUD) on clinical and immunoinflammatory parameters in smokers with generalized aggressive periodontitis (GAgP). Fourteen smoking and 14 non-smoking patients with GAgP were selected. After initial supragingival therapy, patients were treated by OSFMUD. Full-mouth parameters evaluated were: 1) plaque index (PI); 2) bleeding scores (BS); 3) probing depth (PD); and 4) clinical attachment level (CAL). Clinical evaluation was performed, and gingival crevicular fluid (GCF) was collected for selected sites (ss) at baseline and 1, 3, and 6 months. GCF was analyzed via enzyme-linked immunosorbent assay for: 1) receptor activator of nuclear factor-κ B ligand (RANKL); 2) osteoprotegerin (OPG); 3) interleukin (IL)-6; and 4) tumor necrosis factor (TNF)-α, whereas secreted osteoclastogenic factor of activated T-cells (SOFAT) was evaluated by Western blotting. Significant reduction (P <0.05) was observed between baseline and 6 months for: 1) PI; 2) BS; and 3) PD, with no difference between smoking and non-smoking patients (P >0.05). Regarding CAL, only non-smoking patients showed a significant decrease (P <0.05). Significant reduction (P <0.05) was observed in both groups for: 1) PIss; 2) PDss; 3) bleeding on probing; and 4) relative CAL. Smoking and non-smoking patients presented significantly decreased levels of IL-6 and TNF-α over time (P <0.05); however, no difference was observed between groups (P >0.05). RANKL was significantly different (P <0.05) only for non-smokers at 6 months, whereas OPG was not significant (P >0.05). SOFAT expression was significantly lower (P <0.05) after OSFMUD for non-smokers only. Considering the clinical and immunoinflammatory parameters evaluated in this short-term follow-up study, it can be concluded that OSFMUD can be used as an alternative treatment for smokers with GAgP.

Emicizumab Prophylaxis in Hemophilia A with Inhibitors.

PubMed

Oldenburg, Johannes; Mahlangu, Johnny N; Kim, Benjamin; Schmitt, Christophe; Callaghan, Michael U; Young, Guy; Santagostino, Elena; Kruse-Jarres, Rebecca; Negrier, Claude; Kessler, Craig; Valente, Nancy; Asikanius, Elina; Levy, Gallia G; Windyga, Jerzy; Shima, Midori

2017-08-31

Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII, which is deficient in persons with hemophilia A. This phase 3, multicenter trial assessed once-weekly subcutaneous emicizumab prophylaxis in persons with hemophilia A with factor VIII inhibitors. We enrolled participants who were 12 years of age or older. Those who had previously received episodic treatment with bypassing agents were randomly assigned in a 2:1 ratio to emicizumab prophylaxis (group A) or no prophylaxis (group B). The primary end point was the difference in bleeding rates between group A and group B. Participants who had previously received prophylactic treatment with bypassing agents received emicizumab prophylaxis in group C. A total of 109 male participants with hemophilia A with inhibitors were enrolled. The annualized bleeding rate was 2.9 events (95% confidence interval [CI], 1.7 to 5.0) among participants who were randomly assigned to emicizumab prophylaxis (group A, 35 participants) versus 23.3 events (95% CI, 12.3 to 43.9) among those assigned to no prophylaxis (group B, 18 participants), representing a significant difference of 87% in favor of emicizumab prophylaxis (P<0.001). A total of 22 participants in group A (63%) had zero bleeding events, as compared with 1 participant (6%) in group B. Among 24 participants in group C who had participated in a noninterventional study, emicizumab prophylaxis resulted in a bleeding rate that was significantly lower by 79% than the rate with previous bypassing-agent prophylaxis (P<0.001). Overall, 198 adverse events were reported in 103 participants receiving emicizumab prophylaxis; the most frequent events were injection-site reactions (in 15% of participants). Thrombotic microangiopathy and thrombosis were reported in 2 participants each (in the primary analysis) who had received multiple infusions of activated prothrombin complex concentrate for breakthrough bleeding. No antidrug antibodies were detected. Emicizumab prophylaxis was associated with a significantly lower rate of bleeding events than no prophylaxis among participants with hemophilia A with inhibitors. (Funded by F. Hoffmann-La Roche and Chugai Pharmaceutical; HAVEN 1 ClinicalTrials.gov number, NCT02622321 .).

Ticagrelor versus clopidogrel in patients with acute coronary syndromes.

PubMed

Wallentin, Lars; Becker, Richard C; Budaj, Andrzej; Cannon, Christopher P; Emanuelsson, Håkan; Held, Claes; Horrow, Jay; Husted, Steen; James, Stefan; Katus, Hugo; Mahaffey, Kenneth W; Scirica, Benjamin M; Skene, Allan; Steg, Philippe Gabriel; Storey, Robert F; Harrington, Robert A; Freij, Anneli; Thorsén, Mona

2009-09-10

Ticagrelor is an oral, reversible, direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that has a more rapid onset and more pronounced platelet inhibition than clopidogrel. In this multicenter, double-blind, randomized trial, we compared ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-to-600-mg loading dose, 75 mg daily thereafter) for the prevention of cardiovascular events in 18,624 patients admitted to the hospital with an acute coronary syndrome, with or without ST-segment elevation. At 12 months, the primary end point--a composite of death from vascular causes, myocardial infarction, or stroke--had occurred in 9.8% of patients receiving ticagrelor as compared with 11.7% of those receiving clopidogrel (hazard ratio, 0.84; 95% confidence interval [CI], 0.77 to 0.92; P<0.001). Predefined hierarchical testing of secondary end points showed significant differences in the rates of other composite end points, as well as myocardial infarction alone (5.8% in the ticagrelor group vs. 6.9% in the clopidogrel group, P=0.005) and death from vascular causes (4.0% vs. 5.1%, P=0.001) but not stroke alone (1.5% vs. 1.3%, P=0.22). The rate of death from any cause was also reduced with ticagrelor (4.5%, vs. 5.9% with clopidogrel; P<0.001). No significant difference in the rates of major bleeding was found between the ticagrelor and clopidogrel groups (11.6% and 11.2%, respectively; P=0.43), but ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting (4.5% vs. 3.8%, P=0.03), including more instances of fatal intracranial bleeding and fewer of fatal bleeding of other types. In patients who have an acute coronary syndrome with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding. (ClinicalTrials.gov number, NCT00391872.) 2009 Massachusetts Medical Society

Thromboembolic Risk, Bleeding Outcomes and Effect of Different Antithrombotic Strategies in Very Elderly Patients With Atrial Fibrillation: A Sub-Analysis From the PREFER in AF (PREvention oF Thromboembolic Events-European Registry in Atrial Fibrillation).

PubMed

Patti, Giuseppe; Lucerna, Markus; Pecen, Ladislav; Siller-Matula, Jolanta M; Cavallari, Ilaria; Kirchhof, Paulus; De Caterina, Raffaele

2017-07-23

Increasing age predisposes to both thromboembolic and bleeding events in patients with atrial fibrillation; therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. We investigated 1-year outcome with different antithrombotic approaches in very elderly atrial fibrillation patients (age ≥85 years) compared with younger patients. We accessed individual patients' data from the prospective PREFER in AF (PREvention oF thromboembolic events-European Registry in Atrial Fibrillation), compared outcomes with and without oral anticoagulation (OAC), and estimated weighed net clinical benefit in different age groups. A total of 6412 patients, 505 of whom were aged ≥85 years, were analyzed. In patients aged <85 years, the incidence of thromboembolic events was 2.8%/year without OAC versus 2.3%/year with OAC (0.5% absolute reduction); in patients aged ≥85 years, it was 6.3%/year versus 4.3%/year (2% absolute reduction). In very elderly patients, the risk of major bleeding was higher than in younger patients, but similar in patients on OAC and in those on antiplatelet therapy or without antithrombotic treatment (4.0%/year versus 4.2%/year; P =0.77). OAC was overall associated with weighted net clinical benefit, assigning weights to nonfatal events according to their prognostic implication for subsequent death (-2.19%; CI, -4.23%, -0.15%; P =0.036). We found a significant gradient of this benefit as a function of age, with the oldest patients deriving the highest benefit. Because the risk of stroke increases with age more than the risk of bleeding, the absolute benefit of OAC is highest in very elderly patients, where it, by far, outweighs the risk of bleeding, with the greatest net clinical benefit in such patients. © 2017 The Authors and Daiichi Sankyo Europe GmbH. Published on behalf of the American Heart Association, Inc., by Wiley.

Heterozygous congenital Factor VII deficiency with the 9729del4 mutation, associated with severe spontaneous intracranial bleeding in an adolescent male.

PubMed

Cramer, Thomas J; Anderson, Kristin; Navaz, Karanjia; Brown, Justin M; Mosnier, Laurent O; von Drygalski, Annette

2016-03-01

In congenital Factor (F) VII deficiency bleeding phenotype and intrinsic FVII activity levels don't always correlate. Patients with FVII activity levels <30% appear to have a higher bleeding propensity, but bleeding can also occur at higher FVII activity levels. Reasons for bleeding at higher FVII activity levels are unknown, and it remains challenging to manage such patients clinically. A 19year old male with spontaneous intracranial hemorrhage and FVII activity levels of 44%, requiring emergent surgical intervention and a strategy for FVII replacement. Genotyping showed the rare heterozygous FVII 9729del4 mutation. Bleed evacuation was complicated by epidural abscess requiring craniectomy, bone graft procedures, and prolonged administration of recombinant human (rh) activated FVII (FVIIa). The patient recovered without neurological deficits, and remains on prophylactic low dose treatment with rhFVIIa in relation to risky athletic activities. For clinicians, it is important to recognize that effects of rhFVIIa within these pathways are independent of its contribution to blood clot formation and cannot be assessed by clotting assays. Reduced FVII levels should therefore not be dismissed, as even a mild reduction may result in spontaneous bleeding. Treatment of mild FVII deficiency requires a careful case-by-case approach, based on the clinical scenario. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparing the clinical outcomes in patients with atrial fibrillation receiving dual antiplatelet therapy and patients receiving an addition of an anticoagulant after coronary stent implantation: A systematic review and meta-analysis of observational studies.

PubMed

Chaudhary, Nabin; Bundhun, Pravesh Kumar; Yan, He

2016-12-01

Data regarding the clinical outcomes in patients with atrial fibrillation (AF) receiving dual antiplatelet therapy (DAPT) and an anticoagulant in addition to DAPT (DAPT + vitamin K antagonist [VKA]) after coronary stent implantation are still controversial. Therefore, in order to solve this issue, we aim to compare the adverse clinical outcomes in AF patients receiving DAPT and DAPT + VKA after percutaneous coronary intervention and stenting (PCI-S). Observational studies comparing the adverse clinical outcomes such as major bleeding, major adverse cardiovascular events, stroke, myocardial infarction, all-cause mortality, and stent thrombosis (ST) in AF patients receiving DAPT + VKA therapy, and DAPT after PCI-S have been searched from Medline, EMBASE, and PubMed databases. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to express the pooled effect on discontinuous variables, and the pooled analyses were performed with RevMan 5.3. Eighteen studies consisting of a total of 20,456 patients with AF (7203 patients received DAPT + VKA and 13,253 patients received DAPT after PCI-S) were included in this meta-analysis. At a mean follow-up period of 15 months, the risk of major bleeding was significantly higher in DAPT + VKA group, with OR 0.62 (95% CI 0.50-0.77, P < 0.0001). There was no significant differences in myocardial infarction and major adverse cardiovascular event between DAPT + VKA and DAPT, with OR 1.27 (95% CI 0.92-1.77, P = 0.15) and OR 1.17 (95% CI 0.99-1.39, P = 0.07), respectively. However, the ST, stroke, and all-cause mortality were significantly lower in the DAPT + VKA group, with OR 1.98 (95% CI 1.03-3.81, P = 0.04), 1.59 (95% CI 1.08-2.34, P = 0.02), and 1.41 (95% CI 1.03-1.94, P = 0.03), respectively. At a mean follow-up period of 15 months, DAPT + VKA was associated with significantly lower risk of stroke, ST, and all-cause mortality in AF patients after PCI-S compared with DAPT group. However, the risk of major bleeding was significantly higher in the DAPT + VKA group.

Efficacy of combined intravenous immunoglobulins and steroids in children with primary immune thrombocytopenia and persistent bleeding symptoms.

PubMed

Parodi, Emilia; Giordano, Paola; Rivetti, Elisa; Giraudo, Maria Teresa; Ansaldi, Giulia; Davitto, Mirella; Mondino, Anna; Farruggia, Piero; Amendola, Giovanni; Matarese, Sofia M R; Rossi, Francesca; Russo, Giovanna; Ramenghi, Ugo

2014-07-01

The aim of this study was to investigate the effect of the combined administration of intravenous immunoglobulins and steroids as a second-line therapy in 34 children with primary immune thrombocytopenia and persistent, symptomatic bleeding. Combined therapy (intravenous immunoglobulins 0.4 g/kg daily on days 1 and 2, and methylprednisolone 20 mg/kg daily on days 1-3) was administered to 12 patients with newly diagnosed ITP who did not respond to the administration of a single therapy (either intravenous immunoglobulins or steroids) and to 22 children with persistent and chronic disease who required frequent administrations (i.e. more frequently than every 30 days) of either immunoglobulins or steroids (at the same standard dosages) in order to control active bleeding. A response (i.e. platelet count >50×10(9)/L and remission of active bleeding) was observed in 8/12 (67%) patients with newly diagnosed ITP. The clinical presentation of responders and non-responders did not differ apparently. Patients in the chronic/persistent phase of disease had a significantly longer median period of remission from symptoms compared with the previous longest period of remission (p=0.016). The treatment was well tolerated. Our data suggest that the combined approach described is a well-tolerated therapeutic option for children with primary immune thrombocytopenia and persistent bleeding symptoms that can be used in both emergency and/or maintenance settings.

Transcatheter arterial embolization of acute gastrointestinal tumor hemorrhage with Onyx.

PubMed

Sun, C J; Wang, C E; Wang, Y H; Xie, L L; Liu, T H; Ren, W C

2015-02-01

Endovascular embolization has been used to control gastrointestinal tumor bleeding. Lots of embolic agents have been applied in embolization, but liquid embolic materials such as Onyx have been rarely used because of concerns about severe ischemic complications. To evaluate the clinical efficacy and safety of transcatheter arterial embolization (TAE) with Onyx for acute gastrointestinal tumor hemorrhage. Between September 2011 and July 2013, nine patients were diagnosed as acute gastrointestinal tumor hemorrhage by clinical feature and imaging examination. The angiographic findings were extravasation of contrast media in the five patients. The site of hemorrhage included upper gastrointestinal bleeding in seven cases and lower gastrointestinal bleeding in two cases. TAE was performed using Onyx in all the patients, and the blood pressure and heart rate were monitored, the angiographic and clinical success rate, recurrent bleeding rate, procedure related complications and clinical outcomes were evaluated after therapy. The clinical parameters and embolization data were studied retrospectively. All the patients (100%) who underwent TAE with Onyx achieved complete hemostasis without rebleeding and the patients were discharged after clinical improvement without a second surgery. No one of the patients expired during the hospital course. All the patients were discharged after clinical improvement without a second surgery. Postembolization bowel ischemia or necrosis was not observed in any of the patients who received TAE with Onyx. TAE with Onyx is a highly effective and safe treatment modality for acute gastrointestinal tumor hemorrhage, even with pre-existing coagulopathy.

Out-of-range INR values and outcomes among new warfarin patients with non-valvular atrial fibrillation.

PubMed

Nelson, Winnie W; Wang, Li; Baser, Onur; Damaraju, Chandrasekharrao V; Schein, Jeffrey R

2015-02-01

Although efficacious in stroke prevention in non-valvular atrial fibrillation, many warfarin patients are sub-optimally managed. To evaluate the association of international normalized ratio control and clinical outcomes among new warfarin patients with non-valvular atrial fibrillation. Adult non-valvular atrial fibrillation patients (≥18 years) initiating warfarin treatment were selected from the US Veterans Health Administration dataset between 10/2007 and 9/2012. Valid international normalized ratio values were examined from the warfarin initiation date through the earlier of the first clinical outcome, end of warfarin exposure or death. Each patient contributed multiple in-range and out-of-range time periods. The relative risk ratios of clinical outcomes associated with international normalized ratio control were estimated. 34,346 patients were included for analysis. During the warfarin exposure period, the incidence of events per 100 person-years was highest when patients had international normalized ratio <2:13.66 for acute coronary syndrome; 10.30 for ischemic stroke; 2.93 for transient ischemic attack; 1.81 for systemic embolism; and 4.55 for major bleeding. Poisson regression confirmed that during periods with international normalized ratio <2, patients were at increased risk of developing acute coronary syndrome (relative risk ratio: 7.9; 95 % confidence interval 6.9-9.1), ischemic stroke (relative risk ratio: 7.6; 95 % confidence interval 6.5-8.9), transient ischemic attack (relative risk ratio: 8.2; 95 % confidence interval 6.1-11.2), systemic embolism (relative risk ratio: 6.3; 95 % confidence interval 4.4-8.9) and major bleeding (relative risk ratio: 2.6; 95 % confidence interval 2.2-3.0). During time periods with international normalized ratio >3, patients had significantly increased risk of major bleeding (relative risk ratio: 1.5; 95 % confidence interval 1.2-2.0). In a Veterans Health Administration non-valvular atrial fibrillation population, exposure to out-of-range international normalized ratio values was associated with significantly increased risk of adverse clinical outcomes.

Clinical and Microbial Evaluation of the Effects on Gingivitis of a Mouth Rinse Containing an Enteromorpha linza Extract

PubMed Central

Cho, Han-Bin; Lee, Hee-Hyun; Lee, Ok-Hwan; Choi, Hyeon-Son; Choi, Jae-Suk

2011-01-01

Abstract Enteromorpha linza, a green alga, has been recognized as a potential source of natural antimicrobial and antifungal compounds. We previously reported that an E. linza extract strongly inhibited the growth of Prevotella intermedia and Porphyromonas gingivalis. The principal objective of this study was to evaluate the clinical effect of a mouth rinse containing the E. linza extract on gingivitis disease, as measured by the plaque index (PI), gingival index (GI), and bleeding on probing (BOP), and on two bacterial strains (P. intermedia and P. gingivalis), in comparison with Listerine® (Listerine-Korea, Seoul, Korea), which was used as a positive control. In total, 55 subjects were recruited into active participation in this clinical study. The PI, GI, BOP, and bacterial strains were then evaluated over a test period of 6 weeks. After 1, 2, 4, and 6 weeks, the same clinical indices were recorded, and the levels of P. intermedia and P. gingivalis were quantified via real-time polymerase chain reaction. At the end of the study, the group using the mouth rinse containing the E. linza extract evidenced significant reductions in the clinical indices (PI, GI, and BOP) and P. gingivalis compared with baseline values. Moreover, E. linza extract containing mouth rinse produced effects similar to those of Listerine. Overall, these results indicate that a mouth rinse containing E. linza extract significantly reduces plaque, improves the condition of gingival tissues, and reduces bleeding. Additionally, E. linza extract mouth rinse significantly inhibits P. gingivalis and P. intermedia. Thus, this clinical study demonstrated that the twice-daily use of an E. linza extract mouth rinse can inhibit and prevent gingivitis. PMID:22145775

The Effect of Apically Repositioned Flap Surgery on Clinical Parameters and the Composition of the Subgingival Microbiota: 12-Month Data

PubMed Central

Levy, Rustin M.; Giannobile, William V.; Feres, Magda; Haffajee, Anne D.; Smith, Claire; Socransky, Sigmund S.

2008-01-01

The purpose of this investigation was to examine the clinical and microbiologic effects of apically repositioned flap surgery. Eighteen patients with chronic periodontitis received initial preparation (IP) including scaling and root planing, followed at 3 months by apically repositioned flap surgery at sites with pocket depth > 4 mm. Subjects were monitored clinically and microbiologically at baseline, 3 months after IP, and at 3, 6, 9, and 12 months postsurgery. Clinical assessments of plaque accumulation, gingival redness, suppuration, bleeding on probing, pocket depth, and attachment level were made at six sites per tooth. Subgingival plaque samples were taken from the mesial aspect of each tooth, and the presence and levels of 40 subgingival taxa were determined using checkerboard DNA-DNA hybridization. Significant reductions were seen in mean pocket depth and percentage of sites exhibiting gingival redness and bleeding on probing in both sites that received IP only and in sites receiving IP followed by surgery. Mean attachment level increased significantly for both sets of sites, but the increase was greater at the surgically treated sites. The total DNA probe counts were significantly reduced at sites in both treatment groups. At surgically treated sites, 19 of 40 taxa were significantly reduced posttherapy. At sites receiving IP only, 16 species were significantly reduced over time. While there were some reductions in mean counts after IP in this site group, the major reductions occurred after the surgical phase in these patients, even though these particular sites did not receive surgical therapy. The reduction in pocket depth by surgical means and the associated decrease in reservoirs of periodontal pathogens may be important in achieving sustained periodontal stability. PMID:12186343

The effects of Lactobacillus reuteri probiotics combined with azithromycin on peri-implantitis: A randomized placebo-controlled study.

PubMed

Tada, Hiroaki; Masaki, Chihiro; Tsuka, Shintaro; Mukaibo, Taro; Kondo, Yusuke; Hosokawa, Ryuji

2018-01-01

The aim of this randomized placebo-controlled clinical study was to investigate the effects of a probiotic tablet containing Lactobacillus reuteri in peri-implantitis patients. Subjects comprised 30 patients with mild to moderate peri-implantitis. A baseline clinical examination and microbiological assessment were conducted, followed by an antibiotics treatment (azithromycin, 500mg, once a day for 3 days). Subjects were divided into probiotic and placebo groups. The clinical examination and bacterial sampling were performed 0, 4, 12 and 24 weeks after the intake of probiotics. The clinical examination included probing pocket depth (PPD), bleeding on probing (BOP), the modified plaque index (mPI), and modified bleeding index (mBI). The number of bacteria was assessed using the PCR-invader method. The Wilcoxon rank-sum test and Wilcoxon signed-rank test with Bonferroni corrections were used for data analyses. Although the number of bacteria decreased after the administration of azithromycin in both groups, they increased again thereafter. No significant difference was observed in bacterial numbers between the two groups. Although PPD in the probiotics group was significantly lower at 4 and 24 weeks than at 0 weeks (p<0.05), a significant decrease did not occur in the placebo group. The mBI score at 24 weeks was significantly lower in the probiotics group than in the placebo group (p<0.05). No significant difference was observed in BOP or mPI between the two groups. These results suggested that probiotics prevent inflammation by affecting host responses rather than improving microbial flora in peri-implant sulci in peri-implantitis patients. Copyright © 2017 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Coagulation is more affected by quick than slow bleeding in patients with massive blood loss.

PubMed

Zhao, Juan; Yang, Dejuan; Zheng, Dongyou

2017-03-01

Profuse blood loss affects blood coagulation to various degrees. However, whether bleeding speed affects coagulation remains uncertain. This study aimed to evaluate the effect of bleeding speed on coagulation function. A total of 141 patients in the Department of Thoracic Surgery of our hospital were evaluated between January 2007 and February 2014. There are two groups of patients, those who received decortication for chronic encapsulated empyema were called the slow-bleeding group, and those who received thoracoscopic upper lobectomy were called the fast bleeding group; each group was further subdivided into three: group A, 1000 ml ≤ bleeding amount < 1500 ml; group B, 1500 ml ≤ bleeding amount < 1700 ml; group C, 1700 ml ≤ bleeding amount < 2000 ml. Then, coagulation function was assessed in all patients before and during surgery and at 1, 2, and 24 h after surgery, measuring prothrombin time, activated partial thromboplastin time (APTT), fibrinogen, blood pressure, hematocrit, hemoglobin, and platelets. Bleeding duration was overtly longer in the slow-bleeding group than that in quick bleeding individuals (2.3 ± 0.25 h vs. 0.41 ± 0.13 h, P < 0.001). Fibrinogen, hematocrit, hemoglobin, and platelets strikingly decreased, whereas prothrombin time and APTT values significantly increased with bleeding amounts in both quick and slow-bleeding groups. Interestingly, compared with slow-bleeding patients, coagulation indices at each time point and bleeding amounts had significant differences in the quick bleeding group.Increased consumption of coagulation factors in quick bleeding may have greater impact on coagulation function.

Administration of recombinant activated factor VII in the intensive care unit after complex cardiovascular surgery: clinical and economic outcomes.

PubMed

Uber, Walter E; Toole, John M; Stroud, Martha R; Haney, Jason S; Lazarchick, John; Crawford, Fred A; Ikonomidis, John S

2011-06-01

Refractory bleeding after complex cardiovascular surgery often leads to increased length of stay, cost, morbidity, and mortality. Recombinant activated factor VII administered in the intensive care unit can reduce bleeding, transfusion, and surgical re-exploration. We retrospectively compared factor VII administration in the intensive care unit with reoperation for refractory bleeding after complex cardiovascular surgery. From 1501 patients who underwent cardiovascular procedures between December 2003 and September 2007, 415 high-risk patients were identified. From this cohort, 24 patients were divided into 2 groups based on whether they either received factor VII in the intensive care unit (n = 12) or underwent reoperation (n = 12) for refractory bleeding. Preoperative and postoperative data were collected to compare efficacy, safety, and economic outcomes. In-hospital survival for both groups was 100%. Factor VII was comparable with reoperation in achieving hemostasis, with both groups demonstrating decreases in chest tube output and need for blood products. Freedom from reoperation was achieved in 75% of patients receiving factor VII, whereas reoperation was effective in achieving hemostasis alone in 83.3% of patients. Prothrombin time, international normalized ratio, and median operating room time were significantly less (P < .05) in patients who received factor VII. Both groups had no statistically significant differences in other efficacy, safety, or economic outcomes. Factor VII administration in the intensive care unit appears comparable with reoperation for refractory bleeding after complex cardiovascular surgical procedures and might represent an alternative to reoperation in selected patients. Future prospective, randomized controlled trials might further define its role. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.

PubMed

Sitter, Helmut; Lorenz, Wilfried; Nicolay, Uwe; Krack, Walter; Hellenbrandt, Armin; Zielke, Andreas; Gajek, Hartwig; Ledertheil, Gertrud

2003-03-01

A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol. To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes. A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group). An incremental cost-effectiveness analysis and comparison of outcomes was performed using chi-squared tests and Kaplan-Meier survival analysis. A survey was carried out using a questionnaire in the five hospitals on local guidelines for management of ulcer bleeding, and its results were analysed qualitatively. The measure of effectiveness is the number of prevented rebleedings. Further variables were length of hospital stay and length of intensive care unit (ICU) stay. The cost for the prevention of one additional rebleeding by repeated fibrin glue treatment amounts to 14,316 +/- 4981 euros (incremental cost-effectiveness ratio). There were no significant differences in length of stays in ICU or in hospital. The physicians did not change their management plans for patients with upper-gastrointestinal bleeding. In a survey, it was seen that other factors, such as local guidelines, attitudes towards new treatment options, and ease of handling of drugs, are more important than a result of a single study for a behavioural change of the doctors. The study was not designed prospectively to address a pharmacoeconomic question. As relevant variables (e.g. length of ICU stay) could not be reliably ascertained retrospectively, this may lead to biased estimates of the incremental cost-effectiveness ratio.

A Smart Capsule System for Automated Detection of Intestinal Bleeding Using HSL Color Recognition

PubMed Central

Liu, Hongying; Yan, Xueping; Jia, Ziru; Pi, Xitian

2016-01-01

There are no ideal means for the diagnosis of intestinal bleeding diseases as of now, particularly in the small intestine. This study investigated an intelligent intestinal bleeding detection capsule system based on color recognition. After the capsule is swallowed, the bleeding detection module (containing a color-sensitive adsorptive film that changes color when absorbing intestinal juice,) is used to identify intestinal bleeding features. A hue-saturation-light color space method can be applied to detect bleeding according to the range of H and S values of the film color. Once bleeding features are recognized, a wireless transmission module is activated immediately to send an alarm signal to the outside; an in vitro module receives the signal and sends an alarm. The average power consumption of the entire capsule system is estimated to be about 2.1mW. Owing to its simplicity, reliability, and effectiveness, this system represents a new approach to the clinical diagnosis of intestinal bleeding diseases. PMID:27902728

Protein C deficiency related obscure gastrointestinal bleeding treated by enteroscopy and anticoagulant therapy.

PubMed

Hsu, Wei-Fan; Tsang, Yuk-Ming; Teng, Chung-Jen; Chung, Chen-Shuan

2015-01-21

Obscure gastrointestinal bleeding is an uncommonly encountered and difficult-to-treat clinical problem in gastroenterology, but advancements in endoscopic and radiologic imaging modalities allow for greater accuracy in diagnosing obscure gastrointestinal bleeding. Ectopic varices account for less than 5% of all variceal bleeding cases, and jejunal variceal bleeding due to extrahepatic portal hypertension is rare. We present a 47-year-old man suffering from obscure gastrointestinal bleeding. Computed tomography of the abdomen revealed multiple vascular tufts around the proximal jejunum but no evidence of cirrhosis, and a visible hypodense filling defect suggestive of thrombus was visible in the superior mesenteric vein. Enteroscopy revealed several serpiginous varices in the proximal jejunum. Serologic data disclosed protein C deficiency (33.6%). The patient was successfully treated by therapeutic balloon-assisted enteroscopy and long-term anticoagulant therapy, which is normally contraindicated in patients with gastrointestinal bleeding. Diagnostic modalities for obscure gastrointestinal bleeding, such as capsule endoscopy, computed tomography enterography, magnetic resonance enterography, and enteroscopy, were also reviewed in this article.

Apixaban: A Review in Venous Thromboembolism.

PubMed

Greig, Sarah L; Garnock-Jones, Karly P

2016-10-01

Apixaban (Eliquis ® ) is an oral, direct factor Xa inhibitor that is available for use in the treatment and secondary prevention of venous thromboembolism (VTE). Like other direct oral anticoagulants (DOACs), apixaban has generally predictable pharmacological properties and does not require routine anticoagulation monitoring. In large phase III trials, oral apixaban was noninferior to subcutaneous enoxaparin sodium overlapped with and followed by oral warfarin (enoxaparin/warfarin) in the treatment of adults with acute VTE over 6 months with regard to the incidence of recurrent VTE or VTE-related death (AMPLIFY), and was significantly more effective than placebo in the prevention of recurrent VTE or all-cause mortality over 12 months in patients who had completed 6-12 months' anticoagulation treatment for VTE (AMPLIFY-EXT). Apixaban was generally well tolerated in these trials; the risks of major bleeding and the composite endpoint of major or clinically relevant nonmajor (CRNM) bleeding with apixaban were significantly lower than enoxaparin/warfarin in AMPLIFY and not significantly different from that of placebo in AMPLIFY-EXT. Similarly, in Japanese adults with acute VTE (AMPLIFY-J), apixaban was associated with a significantly lower risk of major or CRNM bleeding than unfractionated heparin plus warfarin, and no cases of recurrent VTE or VTE-related death over 24 weeks. Thus, apixaban is useful therapeutic alternative for the management of adults with VTE.

Upper gastrointestinal bleeding risk scores: Who, when and why?

PubMed Central

Monteiro, Sara; Gonçalves, Tiago Cúrdia; Magalhães, Joana; Cotter, José

2016-01-01

Upper gastrointestinal bleeding (UGIB) remains a significant cause of hospital admission. In order to stratify patients according to the risk of the complications, such as rebleeding or death, and to predict the need of clinical intervention, several risk scores have been proposed and their use consistently recommended by international guidelines. The use of risk scoring systems in early assessment of patients suffering from UGIB may be useful to distinguish high-risks patients, who may need clinical intervention and hospitalization, from low risk patients with a lower chance of developing complications, in which management as outpatients can be considered. Although several scores have been published and validated for predicting different outcomes, the most frequently cited ones are the Rockall score and the Glasgow Blatchford score (GBS). While Rockall score, which incorporates clinical and endoscopic variables, has been validated to predict mortality, the GBS, which is based on clinical and laboratorial parameters, has been studied to predict the need of clinical intervention. Despite the advantages previously reported, their use in clinical decisions is still limited. This review describes the different risk scores used in the UGIB setting, highlights the most important research, explains why and when their use may be helpful, reflects on the problems that remain unresolved and guides future research with practical impact. PMID:26909231

Bleeding complications and mortality in warfarin-treated VTE patients, dependence of INR variability and iTTR.

PubMed

Sandén, Per; Renlund, Henrik; Svensson, Peter J; Själander, Anders

2017-01-05

High quality of warfarin treatment is important to prevent recurrence of venous thromboembolism (VTE) without bleeding complications. The aim of this study was to examine the effect of individual time in therapeutic range (iTTR) and International Normalised Ratio (INR) variability on bleeding risk and mortality in a large cohort of well-managed patients with warfarin due to VTE. A cohort of 16612 patients corresponding to 19502 treatment periods with warfarin due to VTE between January 1, 2006 and December 31, 2011 was retrieved from the Swedish national quality register AuriculA and matched with the Swedish National Patient Register for bleeding complications and background characteristics and the Cause of death register for occurrence and date of death. The rate of bleeding was 1.79 (confidence interval (CI) 95 % 1.66-1.93) per 100 treatment years among all patients. Those with poor warfarin treatment quality had a higher rate of clinically relevant bleeding, both when measured as iTTR below 70 %, 2.91 (CI 95 % 2.61-3.21) or as INR variability over the mean value 0.85, 2.61 (CI 95 % 2.36-2.86). Among those with both high INR variability and low iTTR the risk of clinically relevant bleeding was clearly increased hazard ratio (HR) 3.47 (CI 95 % 2.89-4.17). A similar result was found for all-cause mortality with a HR of 3.67 (CI 95 % 3.02-4.47). Both a low iTTR and a high INR variability increase the risk of bleeding complications or mortality. When combining the two treatment quality indicators patients at particular high risk of bleeding or death can be identified.

Outcomes of Propofol Sedation During Emergency Endoscopy Performed for Upper Gastrointestinal Bleeding.

PubMed

Park, Chan Hyuk; Han, Dong Soo; Jeong, Jae Yoon; Eun, Chang Soo; Yoo, Kyo-Sang; Jeon, Yong Cheol; Sohn, Joo Hyun

2016-03-01

Although propofol-based sedation can be used during emergency endoscopy for upper gastrointestinal bleeding (UGIB), there is a potential risk of sedation-related adverse events, especially in patients with variceal bleeding. We compared adverse events related to propofol-based sedation during emergency endoscopy between patients with non-variceal and variceal bleeding. Clinical records of patients who underwent emergency endoscopy for UGIB under sedation were reviewed. Adverse events, including shock, hypoxia, and paradoxical reaction, were compared between the non-variceal and variceal bleeding groups. Of 703 endoscopies, 539 and 164 were performed for non-variceal and variceal bleeding, respectively. Shock was more common in patients with variceal bleeding compared to those with non-variceal bleeding (12.2 vs. 3.5%, P < 0.001). All patients except one recovered from shock after normal saline hydration, and emergency endoscopy could be finished without interruption in most cases. The incidence of hypoxia and paradoxical reaction did not differ based on the source of bleeding (non-variceal bleeding vs. variceal bleeding: hypoxia, 3.5 vs. 1.8%, P = 0.275; paradoxical reaction interfering with the procedure, 4.1 vs. 5.5%, P = 0.442). Although shock was more common in patients with variceal bleeding compared to those with non-variceal bleeding, most cases could be controlled without procedure interruption. Paradoxical reaction, rather than shock or hypoxia, was the most common cause of procedure interruption in patients with variceal bleeding, but the rate did not differ between patients with non-variceal and variceal bleeding.

No. 292-Abnormal Uterine Bleeding in Pre-Menopausal Women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2018-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e. g., uterine hemorrhage, menorrhagia) and key words (e. g., menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology- related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered. RECOMMENDATIONS. Copyright © 2018. Published by Elsevier Inc.

Abnormal uterine bleeding in pre-menopausal women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2013-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e.g. uterine hemorrhage, menorrhagia) and key words (e.g. menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered.

Duodenal plexiform fibromyxoma as a cause of obscure upper gastrointestinal bleeding: A case report.

PubMed

Moris, Demetrios; Spanou, Evangelia; Sougioultzis, Stavros; Dimitrokallis, Nikolaos; Kalisperati, Polyxeni; Delladetsima, Ioanna; Felekouras, Evangelos

2017-01-01

We are reporting the first-to our knowledge-case of duodenal Plexiform Fibromyxoma causing obscure upper gastrointestinal bleeding. Plexiform fibromyxoma triggered recurrent upper gastrointestinal bleeding episodes in a 63-year-old man who remained undiagnosed, despite multiple hospitalizations, extensive diagnostic workups and surgical interventions (including gastrectomies), for almost 17 years. During hospitalization for the last bleeding episode, an upper gastrointestinal endoscopy revealed an intestinal hemorrhagic nodule. The lesion was deemed unresectable by endoscopic means. An abdominal computerized tomography disclosed no further lesions and surgery was decided. The lesion at operation was found near the edge of the duodenal stump and treated with pancreas-preserving duodenectomy (1st and 2nd portion). Postoperative recovery was mainly uneventful and a 20-month follow-up finds the patient in good health with no need for blood transfusions.Plexiform fibromyxomas stand for a rare and widely unknown mesenchymal entity. Despite the fact that they closely resemble other gastrointestinal tumors, they distinctly vary in clinical management as well as the histopathology. Clinical awareness and further research are compulsory to elucidate its clinical course and prognosis.

Clinical characteristics and outcomes of acquired hemophilia A: experience at a single center in Japan.

PubMed

Ogawa, Yoshiyuki; Yanagisawa, Kunio; Uchiumi, Hideki; Ishizaki, Takuma; Mitsui, Takeki; Gouda, Fumito; Ieko, Masahiro; Ichinose, Akitada; Nojima, Yoshihisa; Handa, Hiroshi

2017-07-01

Acquired hemophilia A (AHA), which is caused by autoantibodies against coagulation factor VIII (FVIII) is a rare, life-threatening bleeding disorder, the incidence of which appears to be increasing in Japan as the population ages. However, the clinical characteristics, treatment, and outcomes of AHA remain difficult to establish due to the rarity of this disease. We retrospectively analyzed data from 25 patients (median age 73 years; range 24-92 years; male n = 15) diagnosed with AHA between 1999 and 2015 at Gunma University Hospital. We identified autoimmune diseases and malignancy as underlying conditions in four and three patients, respectively. Factor VIII activity was significantly decreased in all patients (median 2.0%; range <1.0-8.0) by FVIII inhibitor (median 47.0 BU/mL; range 2.0-1010). Among 71 bleeding events, subcutaneous or intramuscular hemorrhage was the most prevalent. Seventeen patients required bypassing agents. Twenty-two (91.7%) of 24 patients treated with immunosuppressive agents achieved complete response (CR) during a median of 57.5 days (range 19-714 days). Although three patients (12%) relapsed and seven (28%) died of infection, none of the deaths were related to bleeding. Although most of our patients achieved CR after immunosuppressive therapy, the rate of infection-related mortality was unsatisfactorily high.

Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial.

PubMed

Vinereanu, Dragos; Stevens, Susanna R; Alexander, John H; Al-Khatib, Sana M; Avezum, Alvaro; Bahit, Marıa Cecilia; Granger, Christopher B; Lopes, Renato D; Halvorsen, Sigrun; Hanna, Michael; Husted, Steen; Hylek, Elaine M; Mărgulescu, Andrei D; Wallentin, Lars; Atar, Dan

2015-12-07

To assess clinical outcomes, efficacy, and safety according to sex during anticoagulation with apixaban compared with warfarin in patients with atrial fibrillation. Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) was a randomized, double-blind, placebo-controlled, multicentre trial that included 11 785 (64.7%) men and 6416 (35.3%) women with atrial fibrillation or flutter randomized to receive either warfarin or apixaban. The primary efficacy endpoint was stroke or systemic embolism; secondary efficacy endpoints were death from any cause and cardiovascular death. The primary safety endpoint was major bleeding; secondary safety endpoints were a composite of major bleeding and non-major clinically relevant bleeding. The risk of stroke or systemic embolism was similar in women vs. men [adjusted hazard ratio (adjHR): 0.91; 95% confidence interval (CI): 0.74-1.12; P = 0.38]. However, among patients with history of stroke or transient ischaemic attack, women had a lower risk of recurrent stroke compared with men (adjHR: 0.70; 95% CI: 0.50-0.97; P = 0.036). Women also had a lower risk of all-cause death (adjHR: 0.63; 95% CI: 0.55-0.73; P < 0.0001) and cardiovascular death (adjHR: 0.62; 95% CI: 0.51-0.75; P < 0.0001), and a trend towards less major bleeding (adjHR: 0.86; 95% CI: 0.74-1.01; P = 0.066) and major or non-major clinically relevant bleeding (adjHR: 0.89; 95% CI: 0.80-1.00; P = 0.049). The efficacy and safety benefits of apixaban compared with warfarin were consistent regardless of sex. In the ARISTOTLE trial, women had a similar rate of stroke or systemic embolism but a lower risk of mortality and less clinically relevant bleeding than men. The efficacy and safety benefits of apixaban compared with warfarin were consistent in men and women. ARISTOTLE ClinicalTrials.gov number, NCT00412984. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Transfusion strategy for acute upper gastrointestinal bleeding.

PubMed

Handel, James; Lang, Eddy

2015-09-01

Clinical question Does a hemoglobin transfusion threshold of 70 g/L yield better patient outcomes than a threshold of 90 g/L in patients with acute upper gastrointestinal bleeding? Article chosen Villanueva C, Colomo A, Bosch A, et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med 2013;368(1):11-21. Study objectives The authors of this study measured mortality, from any cause, within the first 45 days, in patients with acute upper gastrointestinal bleeding, who were managed with a hemoglobin threshold for red cell transfusion of either 70 g/L or 90 g/L. The secondary outcome measures included rate of further bleeding and rate of adverse events.

Levels of interleukin-1β in gingival crevicular fluid in patients with coronary heart disease and its relationship to periodontal status

NASA Astrophysics Data System (ADS)

Lenggogeny, Putri; Masulili, Sri Lelyati C.; Tadjoedin, Fatimah M.; Radi, Basuni

2017-02-01

Periodontitis is a risk factor for coronary heart disease (CHD). Both diseases are an inflammatory diseases and have the same potential pathogenic mechanisms. Interleukin-1β as a pro-inflammatory main cytokine, can be found in this both diseases. Gingival crevicular fluid (GCF) derived from the serum of gingival sulcus, affected by inflammatory mechanism and the amount of this fluid will increase in that situation. Objective: To analyze the relationship of interleukin-1β levels in gingival crevicular fluid (GCF) of CHD and non-CHD patients with periodontal status. Methods: Oral clinical examination (plaque index, bleeding on probing, pocket depth and clinical attachment loss) for 35 subjects with CHD and 35 non CHD were checked, laboratory test to measure the levels of Interleukin-1β was checked with enzyme-linked immunosorbent assay (ELISA). Results: There was no significant differences between interleukin-1β levels in CHD and non-CHD patients (p>0.05); there was no significant difference between the level of Interleukin-1β with periodontal status in CHD and control (non CHD) patients (p>0.05). Conclusions: levels of Interleukin-1β in CHD patients do not have a relationships with plaque index, pocket depth and clinical attachment loss, but has a relationships with bleeding on probing.

Neonatal Plasma Transfusion: An Evidence-Based Review.

PubMed

Keir, Amy K; Stanworth, Simon J

2016-10-01

Several clinical scenarios for plasma transfusion are repeatedly identified in audits, including treatment of bleeding in association with laboratory evidence of coagulopathy, correction of disseminated intravascular coagulation, prevention of intraventricular hemorrhage, management of critically ill neonates (eg, during sepsis or as a volume expander), or correction of markers of prolonged coagulation in the absence of bleeding. The findings of at least one national audit of transfusion practice indicated that almost half of plasma transfusions are given to neonates with abnormal coagulation values with no evidence of active bleeding, despite the limited evidence base to support the effectiveness of this practice. Plasma transfusions to neonates should be considered in the clinical context of bleeding (eg, vitamin K dependent), disseminated intravascular coagulation, and very rare inherited deficiencies of coagulation factors. There seems to be no role for prophylactic plasma to prevent intraventricular hemorrhage or for use as a volume expander. Copyright © 2016 Elsevier Inc. All rights reserved.

Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials.

PubMed

Qaderdan, Khalid; Vos, Gerrit-Jan A; McAndrew, Thomas; Steg, Philippe Gabriel; Hamm, Christian W; Van't Hof, Arnoud; Mehran, Roxana; Deliargyris, Efthymios N; Bernstein, Debra; Stone, Gregg W; Ten Berg, Jurriën M

2017-12-01

Since older age is a strong predictor of not only bleeding but also of ischemic events, understanding the risk:benefit profile of bivalirudin in the elderly undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation (STEMI) is important. For this, we aim to compare elderly with young patients, who all underwent pPCI for STEMI and randomly received either bivalirudin or heparin. We performed a patient-level pooled analysis (n=5800) of two large randomized trials. A total of 2149 (37.1%) elderly patients (>65 years of age) with STEMI were enrolled and randomly assigned to either bivalirudin or heparin with or without a GPI (control group) before pPCI. Clinical outcomes at 30 days were analyzed. In elderly patients, bivalirudin significantly reduced non-CABG major bleeding (7.1% vs 10.4%; P<.01), subacute ST (0.4% vs 1.5%; P<.01), and net adverse clinical events (NACE; composite of all-cause mortality, reinfarction, IDR, stroke or protocol-defined non-CABG major bleeding [13.7% vs 17.2%; P=.03]) with comparable rates of stroke, MI, acute ST, or all-cause death, when compared with heparin with or without GPI. In a large group of elderly patients enrolled in the EUROMAX and HORIZONS-AMI trials, bivalirudin was associated with lower 30-day rates of non-CABG major bleeding, subacute ST and NACE, with similar 30-day rates of acute ST and mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

A randomized controlled clinical and histopathological trial comparing excisional biopsies of oral fibrous hyperplasias using CO2 and Er:YAG laser.

PubMed

Suter, Valerie G A; Altermatt, Hans Jörg; Bornstein, Michael M

2017-04-01

This study was conducted in order to compare clinical and histopathological outcomes for excisional biopsies when using pulsed CO 2 laser versus Er:YAG laser. Patients (n = 32) with a fibrous hyperplasia in the buccal mucosa were randomly allocated to the CO 2 (140 Hz, 400 μs, 33 mJ) or the Er:YAG laser (35 Hz, 297 μs, 200 mJ) group. The duration of excision, intraoperative bleeding and methods to stop the bleeding, postoperative pain (VAS; ranging 0-100), the use of analgesics, and the width of the thermal damage zone (μm) were recorded and compared between the two groups. The median duration of the intervention was 209 s, and there was no significant difference between the two methods. Intraoperative bleeding occurred in 100% of the excisions with Er:YAG and 56% with CO 2 laser (p = 0.007). The median thermal damage zone was 74.9 μm for CO 2 and 34.0 μm for Er:YAG laser (p < 0.0001). The median VAS score on the evening after surgery was 5 for the CO 2 laser and 3 for the Er:YAG group. To excise oral soft tissue lesions, CO 2 and Er:YAG lasers are both valuable tools with a short time of intervention and postoperative low pain. More bleeding occurs with the Er:YAG than CO 2 laser, but the lower thermal effect of Er:YAG laser seems advantageous for histopathological evaluation.

Prevalence, Type and Etiology of Dental and Soft Tissue Injuries in Children in Croatia.

PubMed

Škaričić, Josip; Vuletić, Marko; Hrvatin, Sandra; Jeličić, Jesenka; Čuković-Bagić, Ivana; Jurić, Hrvoje

2016-06-01

The prevalence, type and etiology of dental and soft tissue injuries and relationship between the time of arrival and sustaining soft tissue injury were analyzed in this retrospective study conducted at the Department of Pediatric Dentistry, University Dental Clinic in Zagreb, Croatia, during the 2010-2014 period using documentation on 447 patients (264 male and 183 female) aged 1-16 years with injuries of primary and permanent teeth. The highest prevalence of traumatic dental injury (TDI) was found in the 7-12 age group and maxillary central incisors were most frequently affected (80.9%) in both primary and permanent dentitions. Enamel-dentin fracture without pulp exposure (31.9%) was the most common TDI of dental hard tissue in both dentitions, whereas subluxation (27.3%) was the most common periodontal tissue injury type. The most frequent location, cause and seasonal variation of trauma were at home, falling and spring. Soft tissue injuries were observed in 203 (45.4%) patients. Soft tissue injuries were less likely when fewer teeth were traumatized (p<0.001). Comparison of children with and without soft tissue injuries yielded a statistically significant difference in the time to arrival between primary and permanent teeth (p<0.01). Because soft tissue injuries include bleeding and clinical presentation appears more dramatic, the time elapsed between injury and initial treatment was shorter than in non-bleeding injuries, pointing to the need of education focused on parents and school teachers regarding the importance of immediate therapy for both bleeding and non-bleeding TDIs.

Embolization of Acute Nonvariceal Upper Gastrointestinal Hemorrhage Resistant to Endoscopic Treatment: Results and Predictors of Recurrent Bleeding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Loffroy, Romaric, E-mail: romaric.loffroy@yahoo.fr; Rao, Pramod; Ota, Shinichi

2010-12-15

Acute nonvariceal upper gastrointestinal (UGI) hemorrhage is a frequent complication associated with significant morbidity and mortality. The most common cause of UGI bleeding is peptic ulcer disease, but the differential diagnosis is diverse and includes tumors; ischemia; gastritis; arteriovenous malformations, such as Dieulafoy lesions; Mallory-Weiss tears; trauma; and iatrogenic causes. Aggressive treatment with early endoscopic hemostasis is essential for a favorable outcome. However, severe bleeding despite conservative medical treatment or endoscopic intervention occurs in 5-10% of patients, requiring surgery or transcatheter arterial embolization. Surgical intervention is usually an expeditious and gratifying endeavor, but it can be associated with high operativemore » mortality rates. Endovascular management using superselective catheterization of the culprit vessel, < sandwich> occlusion, or blind embolization has emerged as an alternative to emergent operative intervention for high-risk patients and is now considered the first-line therapy for massive UGI bleeding refractory to endoscopic treatment. Indeed, many published studies have confirmed the feasibility of this approach and its high technical and clinical success rates, which range from 69 to 100% and from 63 to 97%, respectively, even if the choice of the best embolic agent among coils, cyanaocrylate glue, gelatin sponge, or calibrated particles remains a matter of debate. However, factors influencing clinical outcome, especially predictors of early rebleeding, are poorly understood, and few studies have addressed this issue. This review of the literature will attempt to define the role of embolotherapy for acute nonvariceal UGI hemorrhage that fails to respond to endoscopic hemostasis and to summarize data on factors predicting angiographic and embolization failure.« less

Extensive bleeding during surgical treatment for gingival overgrowth in a patient on haemodialysis--a case report and review of the literature.

PubMed

Nishide, N; Nishikawa, T; Kanamura, N

2005-12-01

Before performing renal transplantation, a most important concern is to control any infection, including oral infections before transplantation. The bleeding diathesis of patients with uraemia is a significant clinical concern, especially when surgery is required. A 44-year-old female patient on haemodialysis was referred for evaluation of gingival overgrowth. The patient was planning a renal transplantation two months later. As the lesions were not considered successfully treatable before transplantation, a gingivectomy and teeth extraction was performed. In pre-operative examinations, an abnormal bleeding time was not detected and other coagulation tests were normal. Under general anaesthesia, 19 teeth were extracted and overgrown gingiva was removed. During the operation, extensive blood loss of 1650ml occurred and four units of concentrated red blood cells were transfused. This study suggests that patients with renal failure undergoing dental surgery require careful pre-surgical evaluation including assessment of their coagulation ability.

Predictive factors of mortality within 30 days in patients with nonvariceal upper gastrointestinal bleeding.

PubMed

Lee, Yoo Jin; Min, Bo Ram; Kim, Eun Soo; Park, Kyung Sik; Cho, Kwang Bum; Jang, Byoung Kuk; Chung, Woo Jin; Hwang, Jae Seok; Jeon, Seong Woo

2016-01-01

Nonvariceal upper gastrointestinal bleeding (NVUGIB) is a common medical emergency that can be life threatening. This study evaluated predictive factors of 30-day mortality in patients with this condition. A prospective observational study was conducted at a single hospital between April 2010 and November 2012, and 336 patients with symptoms and signs of gastrointestinal bleeding were consecutively enrolled. Clinical characteristics and endoscopic findings were reviewed to identify potential factors associated with 30-day mortality. Overall, 184 patients were included in the study (men, 79.3%; mean age, 59.81 years), and 16 patients died within 30 days (8.7%). Multivariate analyses revealed that comorbidity of diabetes mellitus (DM) or metastatic malignancy, age ≥ 65 years, and hypotension (systolic pressure < 90 mmHg) during hospitalization were significant predictive factors of 30-day mortality. Comorbidity of DM or metastatic malignancy, age ≥ 65 years, and hemodynamic instability during hospitalization were predictors of 30-day mortality in patients with NVUGIB. These results will help guide the management of patients with this condition.

Variation of renal function over time is associated with major bleeding in patients treated with direct oral anticoagulants for atrial fibrillation.

PubMed

Becattini, C; Giustozzi, M; Ranalli, M G; Bogliari, G; Cianella, F; Verso, M; Agnelli, G; Vedovati, M C

2018-05-01

Essential In patients on treatment with direct anticoagulants (DOACs) variation of renal function is common. The effect of variations of renal function over time on major bleeding is not well defined. Variation of renal function over time is an independent predictor of major bleeding. Identifying conditions associated with variation of renal function may increase safety of DOACs. Background Chronic kidney disease is a risk factor for major bleeding in patients with atrial fibrillation (AF) treated with warfarin. Objective To assess the effect of variations in renal function over time on the risk of major bleeding during treatment with direct oral anticoagulants (DOACs) in patients with non-valvular AF. Methods Consecutive AF patients were prospectively followed after they had received the first DOAC prescription. Estimated glomerular filtration rate (eGFR) was periodically assessed, and the incidence of major bleeding was recorded. A joint survival model was used to estimate the association between variation in eGFR and the risk of major bleeding. Results During a mean follow-up of 575 days, 44 major bleeds occurred in 449 patients (6.1% per patient-year). eGFR over time was inversely and independently associated with the risk of major bleeding; every 1 mL min -1 absolute decrease in eGFR was associated with a 2% increase in the risk of major bleeding (hazard ratio [HR] 1.02, 95% confidence interval [CI] 1.01-1.04). A similar effect of the variation in eGFR over time was observed on the risk of clinically relevant non-major bleeding (HR 1.02, 95% CI 1.01-1.03). Deterioration of renal function leading to a change in eGFR staging was associated with an increase in the risk of major bleeding (HR 2.43, 95% CI 1.33-4.45). Conclusions Variation in renal function over time is associated with the risk of major bleeding in AF patients treated with DOACs in real life. Identification of intervening clinical conditions associated with variation in renal function is essential to reduce the risk of major bleeding and to make DOAC treatment more safe. © 2018 International Society on Thrombosis and Haemostasis.

[Association between platelet-activating factor acetylhydrolase gene polymorphisms and gastrointestinal bleeding in children with Henoch-Schönlein purpura].

PubMed

Wang, Bao-Xiang; Mei, Hong; Peng, Han-Ming; Gao, Yuan; Ding, Yan

2017-04-01

To study the association between the single nucleotide polymorphisms (SNPs) of the ninth exon Val279Phe of platelet-activating factor acetylhydrolase (PAF-AH) gene and gastrointestinal bleeding in children with Henoch-Schönlein purpura (HSP). A total 516 children with HSP were enrolled, among whom 182 had gastrointestinal bleeding and 334 had no gastrointestinal bleeding. PCR was used to investigate the distribution of genotypes and alleles in the SNPs of Val97Phe. The plasma PAF-AH activity was measured, as well as the levels of platelet-activating factor (PAF), granular membrane protein-140 (GMP-140), β-thromboglobulin (β-TG), and platelet factor 4 (PF4). The Val279Phe genotype and allele frequencies were in Hardy-Weinberg equilibrium, and the homozygous genotype TT and heterozygotes accounted for 0.97% and 6.05% respectively. The gastrointestinal bleeding group had a significantly higher allele frequency than the control group (5.22% vs 3.33%; P<0.01). The HSP patients with GG genotype in the gastrointestinal bleeding group had significantly higher levels of plasma PAF and GMP-140 than those in the non-gastrointestinal bleeding group (P<0.05), while the non-gastrointestinal bleeding group had a significantly higher PAF-AH activity than the gastrointestinal bleeding group (P<0.05). There were no significant differences in β-TG and PF4 between the two groups (P>0.05). Val279Phe gene polymorphisms in PAF-AH are associated with PAF-AH activity and PAF and GMP-140 levels and may be a risk factor for HSP with gastrointestinal bleeding.

Lactic Acidosis Induced by Linezolid Mimics Symptoms of an Acute Intracranial Bleed: A Case Report and Literature Review.

PubMed

Zuccarini, Nichole Suzzanne; Yousuf, Tariq; Wozniczka, Daniel; Rauf, Anis Abdul

2016-10-01

Lactic acidosis is common and most often associated with disturbed acid-base balance. Rarely, it can be a life-threatening medication side effect. Hence, determining the etiology of lactic acidosis early in patients is paramount in choosing the correct therapeutic intervention. Although lactic acidosis as an adverse drug reaction of linezolid is a well-recognized and documented clinical entity, the occurrence of such mimicking an acute intracranial bleed has not been reported to our knowledge. The following case is presented as an example of such an occurrence. A 67-year-old woman presented to the emergency department for lethargy, nausea and syncope. The head CT did not demonstrate any bleeding or mass effect, but lab results were significant for elevated lactic acid. The patient recently underwent left total hip replacement surgery, which was complicated by a methicillin-resistant Staphylococcus aureus (MRSA) infection. She received 6 weeks of oral linezolid therapy. And upon learning that key part of her history, the linezolid was discontinued. Her lactic acid rapidly normalized and she was discharged home. Several publications demonstrate that linezolid induces lactic acidosis by disrupting crucial mitochondrial functions. It is essential that clinicians are aware that linezolid can cause lactic acidosis. And, the important reminder is that adverse drug reactions can often mimic common diseases. If it is not recognized early, ominous clinical consequences may occur. In conclusion, linezolid should be suspected and included in the differential diagnosis if lactic acidosis exists with an uncommon clinical picture.

Clinical and economic benefits of extended treatment with apixaban for the treatment and prevention of recurrent venous thromboembolism in Canada.

PubMed

Quon, Peter; Le, Hoa H; Raymond, Vincent; Mtibaa, Mondher; Moshyk, Andriy

2016-06-01

Background and objective Venous thromboembolism (VTE) is associated with long-term clinical and economic burden. Clinical guidelines generally recommend at least 3 months of anticoagulation, but, in clinical practice, concerns over bleeding risk often limit extended treatment. Apixaban was studied for extended VTE treatment in the AMPLIFY-EXT trial, demonstrating superiority to placebo in VTE reduction without increasing risk of major bleeding. This study assessed the long-term clinical and economic benefits of extending treatment with apixaban when clinical equipoise exists compared to standard of care with enoxaparin/warfarin and other novel oral anti-coagulants (NOACs) for the treatment and prevention of recurrent VTE in Canada. Methods A Markov model was developed to follow patients with VTE over their lifetimes. Efficacy and safety for apixaban and enoxaparin/warfarin were based on AMPLIFY and AMPLIFY-EXT, while relative efficacy to other NOACs was synthesized by network meta-analysis (NMA). Dosages for NOACs and enoxaparin/warfarin were based on their respective trials and were given up to 18 months and up to 6 months, followed by no treatment, respectively. Patient quality adjusted life years (QALYs) were based on published studies, and costs for resource utilization were from a Ministry of Health perspective, expressed as 2014 CAD ($). Results Extended treatment with apixaban compared to enoxaparin/warfarin resulted in fewer recurrent VTEs, VTE-related deaths, and bleeding events, but at slightly increased cost. The incremental cost-effectiveness ratio was $4828 per QALY gained. Compared to other NOACs, apixaban had the fewest bleeding events, similar recurrent VTE events, and the lowest overall cost, which was driven by the strong bleeding profile. In scenario analyses of acute and lifetime treatments, apixaban was cost-effective against all strategies. Conclusions Extended treatment with apixaban can offer substantial clinical benefits and is a cost-effective alternative to enoxaparin/warfarin and other NOACs.

Effectiveness of TC-325 (Hemospray) for treatment of diffuse or refractory upper gastrointestinal bleeding – a single center experience

PubMed Central

Cahyadi, Oscar; Bauder, Markus; Meier, Benjamin; Caca, Karel; Schmidt, Arthur

2017-01-01

Background and study aims  TC-325 (Hemospray, Cook Medical) is a powder agent for endoscopic hemostasis in patients with upper gastrointestinal bleeding (UGIB). Although most publications are based on case-reports and retrospective studies, data on efficacy are promising. Here we report our experience with TC-325 for diffuse or refractory UGIB. Patients and methods  Data on patients receiving TC-325 for endoscopic hemostasis from November 2013 to February 2017 at our center were analyzed retrospectively. Primary endpoints were technical success (successful immediate hemostasis) and clinical success (effective hemostasis and no recurrent bleeding). Secondary endpoints were recurrent bleeding within 3 and 7 days, hospital mortality and TC-325 associated complications. TC-325 was used for bleeding not amenable to standard endoscopic treatment (e. g. diffuse bleeding) or as salvage therapy after failure of conventional methods Results  Fifty-two patients received TC-325 treatment. Most of the patients were treated for peptic ulcer bleeding (18/52 patients, 34.6 %) and post-interventional bleeding (13/52 patients, 25 %). Hemospray was used in 23/52 (44.2 %) patients as monotherapy and in 29/52 (55.8 %) patients as a salvage therapy. Application of the powder on the bleeding source was successful in all patients with no therapy-related adverse events (AEs). Immediate hemostasis was achieved in 51/52 (98.1 %) patients. Recurrent bleeding within 3 and 7 days was observed in 22/51 and 25/51 patients respectively (43.1 % and 49 %). The overall clinical success was 56.9 % on day 3 and 51 % on day 7. Total mortality was 15.4 % (8 patients), bleeding associated mortality was 3.8 % (2 patients). There were no therapy-related AEs. Conclusions  TC-325 showed a high technical success rate as monotherapy for bleeding sources not amenable to standard methods or as an “add-on” therapy after unsuccessful hemostasis. However, rebleeding was frequent in this cohort and further studies are warranted to exactly define a treatment algorithm for TC-325 use. PMID:29124127

[Comparison of the HAS-BLED and ATRIA scores for the risk of bleeding in patients aged 75 and over receiving vitamin K antagonist (VKA) therapy and educated VKA-management].

PubMed

Soave, Claire; Chidlovskii, Elena; Lebelhomme, Audrey; Gaboreau, Yoann; Pernod, Gilles; Bosson, Jean Luc; Couturier, Pascal

2015-09-01

Bleeding is the main complication on vitamin K antagonist treatment (VKA), particularly in elderly patients. However, the bleeding risk prediction in geriatric patients remains difficult. We evaluated the predictive value of the HAS-BLED and ATRIA bleeding scores in VKA-treated patients aged 75 and over. Various clinical bleeding risk factors in elderly were also studied. 208 patients were included in a case-control study: 52 hemorrhages cases were compared to 156 hemorrhage-free cases (controls), mean age 83.1 years in cases and 82.6 in controls. This elderly subgroup was provided from the prospective SCORE cohort study (study designed to validate the use of bleeding scores in an ambulatory population). The patients were included during a VKA-therapeutic education between May 2009 and May 2010 in 4 French hospitals, and followed for 1 year. The primary endpoint, collected prospectively, was the occurrence of severe and clinically relevant bleeding events. According to the Receiver operating characteristics (ROC), the ATRIA score was as effective as HAS- BLED to predict all bleeding (c-statistic: 0.59 [95% CI 0.50-0.68] vs 0.56 [0.48-0.65]) including severe bleeding (c-statistic: 0.64 [95% CI 0.49-0.79] vs 0.62 [0.49-0.75]). Multivariate Cox regression analysis showed increasing bleeding risk with anemia (OR = 2.6 [95% CI 1.34-5.23], p = 0.005), serotonin reuptake inhibitors (2.8 [1.08-7.47], 0.034), and family-management of VKA-treatment (2.8 [1.28-6.15], 0.01). ATRIA hemorrhage predictive value can be improved by adding such parameters as family-management of VKA-treatment and serotonin reuptake inhibitors treatment. ATRIA appears as relevant as HAS-BLED in predicting all bleeding including major hemorrhages in elderly patients educated VKA-management. The ATRIA bleeding score is improved by including items of serotonin reuptake inhibitors treatment and family-management of VKA-treatment.

Effectiveness of TC-325 (Hemospray) for treatment of diffuse or refractory upper gastrointestinal bleeding - a single center experience.

PubMed

Cahyadi, Oscar; Bauder, Markus; Meier, Benjamin; Caca, Karel; Schmidt, Arthur

2017-11-01

 TC-325 (Hemospray, Cook Medical) is a powder agent for endoscopic hemostasis in patients with upper gastrointestinal bleeding (UGIB). Although most publications are based on case-reports and retrospective studies, data on efficacy are promising. Here we report our experience with TC-325 for diffuse or refractory UGIB.  Data on patients receiving TC-325 for endoscopic hemostasis from November 2013 to February 2017 at our center were analyzed retrospectively. Primary endpoints were technical success (successful immediate hemostasis) and clinical success (effective hemostasis and no recurrent bleeding). Secondary endpoints were recurrent bleeding within 3 and 7 days, hospital mortality and TC-325 associated complications. TC-325 was used for bleeding not amenable to standard endoscopic treatment (e. g. diffuse bleeding) or as salvage therapy after failure of conventional methods.  Fifty-two patients received TC-325 treatment. Most of the patients were treated for peptic ulcer bleeding (18/52 patients, 34.6 %) and post-interventional bleeding (13/52 patients, 25 %). Hemospray was used in 23/52 (44.2 %) patients as monotherapy and in 29/52 (55.8 %) patients as a salvage therapy. Application of the powder on the bleeding source was successful in all patients with no therapy-related adverse events (AEs). Immediate hemostasis was achieved in 51/52 (98.1 %) patients. Recurrent bleeding within 3 and 7 days was observed in 22/51 and 25/51 patients respectively (43.1 % and 49 %). The overall clinical success was 56.9 % on day 3 and 51 % on day 7. Total mortality was 15.4 % (8 patients), bleeding associated mortality was 3.8 % (2 patients). There were no therapy-related AEs.  TC-325 showed a high technical success rate as monotherapy for bleeding sources not amenable to standard methods or as an "add-on" therapy after unsuccessful hemostasis. However, rebleeding was frequent in this cohort and further studies are warranted to exactly define a treatment algorithm for TC-325 use.

Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Jae Y.; Daignault-Newton, Stephanie; Heath, Gerard

Purpose: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. Methods and Materials: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predictmore » the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. Results: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r{sup 2}=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r{sup 2}=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. Conclusions: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.« less

Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

PubMed

Goodman, Shaun G; Wojdyla, Daniel M; Piccini, Jonathan P; White, Harvey D; Paolini, John F; Nessel, Christopher C; Berkowitz, Scott D; Mahaffey, Kenneth W; Patel, Manesh R; Sherwood, Matthew W; Becker, Richard C; Halperin, Jonathan L; Hacke, Werner; Singer, Daniel E; Hankey, Graeme J; Breithardt, Gunter; Fox, Keith A A; Califf, Robert M

2014-03-11

This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison of different platelet count thresholds to guide administration of prophylactic platelet transfusion for preventing bleeding in people with haematological disorders after myelosuppressive chemotherapy or stem cell transplantation

PubMed Central

Estcourt, Lise J; Stanworth, Simon J; Doree, Carolyn; Hopewell, Sally; Trivella, Marialena; Murphy, Michael F

2015-01-01

Background Platelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding. This is an update of a Cochrane review first published in 2004, and previously updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews looking at these questions individually; this review compares prophylactic platelet transfusion thresholds. Objectives To determine whether different platelet transfusion thresholds for administration of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect the efficacy and safety of prophylactic platelet transfusions in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy or haematopoietic stem cell transplantation (HSCT). Search methods We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6, 23 July 2015), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015. Selection criteria We included RCTs involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with haematological disorders (receiving myelosuppressive chemotherapy or undergoing HSCT) that compared different thresholds for administration of prophylactic platelet transfusions (low trigger (5 × 109/L); standard trigger (10 × 109/L); higher trigger (20 × 109/L, 30 × 109/L, 50 × 109/L); or alternative platelet trigger (for example platelet mass)). Data collection and analysis We used the standard methodological procedures expected by Cochrane. Main results Three trials met our predefined inclusion criteria and were included for analysis in the review (499 participants). All three trials compared a standard trigger (10 × 109/L) versus a higher trigger (20 × 109/L or 30 × 109/L). None of the trials compared a low trigger versus a standard trigger or an alternative platelet trigger. The trials were conducted between 1991 and 2001 and enrolled participants from fairly comparable patient populations. The original review contained four trials (658 participants); in the previous update of this review we excluded one trial (159 participants) because fewer than 80% of participants had a haematological disorder. We identified no new trials in this update of the review. Overall, the methodological quality of the studies was low across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity. Three studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no evidence of a difference in the number of participants with a clinically significant bleeding episode between the standard and higher trigger groups (three studies; 499 participants; risk ratio (RR) 1.35, 95% confidence interval (CI) 0.95 to 1.90; low-quality evidence). One study reported the number of days with a clinically significant bleeding event (adjusted for repeated measures). There was no evidence of a difference in the number of days of bleeding per participant between the standard and higher trigger groups (one study; 255 participants; relative proportion of days with World Health Organization Grade 2 or worse bleeding (RR 1.71, 95% CI 0.84 to 3.48, P = 0.162; authors’ own results; low-quality evidence). Two studies reported the number of participants with severe or life-threatening bleeding. There was no evidence of any difference in the number of participants with severe or life-threatening bleeding between a standard trigger level and a higher trigger level (two studies; 421 participants; RR 0.99, 95% CI 0.52 to 1.88; low-quality evidence). Only one study reported the time to first bleeding episode. There was no evidence of any difference in the time to the first bleeding episode between a standard trigger level and a higher trigger level (one study; 255 participants; hazard ratio 1.11, 95% CI 0.64 to 1.91; low-quality evidence). Only one study reported on all-cause mortality within 30 days from the start of the study. There was no evidence of any difference in all-cause mortality between standard and higher trigger groups (one study; 255 participants; RR 1.78, 95% CI 0.83 to 3.81; low-quality evidence). Three studies reported on the number of platelet transfusions per participant. Two studies reported on the mean number of platelet transfusions per participant. There was a significant reduction in the number of platelet transfusions per participant in the standard trigger group (two studies, mean difference −2.09, 95% CI −3.20 to −0.99; low-quality evidence). One study reported on the number of transfusion reactions. There was no evidence to demonstrate any difference in transfusion reactions between the standard and higher trigger groups (one study; 79 participants; RR 0.07, 95% CI 0.00 to 1.09). None of the studies reported on quality of life. Authors’ conclusions In people with haematological disorders who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found low-quality evidence that a standard trigger level (10 × 109/L) is associated with no increase in the risk of bleeding when compared to a higher trigger level (20 × 109/L or 30 × 109/L). There was low-quality evidence that a standard trigger level is associated with a decreased number of transfusion episodes when compared to a higher trigger level (20 × 109/L or 30 × 109/L). Findings from this review were based on three studies and 499 participants. Without further evidence, it is reasonable to continue with the current practice of administering prophylactic platelet transfusions using the standard trigger level (10 × 109/L) in the absence of other risk factors for bleeding. PMID:26576687

Comparison of different platelet count thresholds to guide administration of prophylactic platelet transfusion for preventing bleeding in people with haematological disorders after myelosuppressive chemotherapy or stem cell transplantation.

PubMed

Estcourt, Lise J; Stanworth, Simon J; Doree, Carolyn; Hopewell, Sally; Trivella, Marialena; Murphy, Michael F

2015-11-18

Platelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.This is an update of a Cochrane review first published in 2004, and previously updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews looking at these questions individually; this review compares prophylactic platelet transfusion thresholds. To determine whether different platelet transfusion thresholds for administration of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect the efficacy and safety of prophylactic platelet transfusions in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy or haematopoietic stem cell transplantation (HSCT). We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6, 23 July 2015), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015. We included RCTs involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with haematological disorders (receiving myelosuppressive chemotherapy or undergoing HSCT) that compared different thresholds for administration of prophylactic platelet transfusions (low trigger (5 x 10(9)/L); standard trigger (10 x 10(9)/L); higher trigger (20 x 10(9)/L, 30 x 10(9)/L, 50 x 10(9)/L); or alternative platelet trigger (for example platelet mass)). We used the standard methodological procedures expected by Cochrane. Three trials met our predefined inclusion criteria and were included for analysis in the review (499 participants). All three trials compared a standard trigger (10 x 10(9)/L) versus a higher trigger (20 x 10(9)/L or 30 x 10(9)/L). None of the trials compared a low trigger versus a standard trigger or an alternative platelet trigger. The trials were conducted between 1991 and 2001 and enrolled participants from fairly comparable patient populations.The original review contained four trials (658 participants); in the previous update of this review we excluded one trial (159 participants) because fewer than 80% of participants had a haematological disorder. We identified no new trials in this update of the review.Overall, the methodological quality of the studies was low across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity.Three studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no evidence of a difference in the number of participants with a clinically significant bleeding episode between the standard and higher trigger groups (three studies; 499 participants; risk ratio (RR) 1.35, 95% confidence interval (CI) 0.95 to 1.90; low-quality evidence).One study reported the number of days with a clinically significant bleeding event (adjusted for repeated measures). There was no evidence of a difference in the number of days of bleeding per participant between the standard and higher trigger groups (one study; 255 participants; relative proportion of days with World Health Organization Grade 2 or worse bleeding (RR 1.71, 95% CI 0.84 to 3.48, P = 0.162; authors' own results; low-quality evidence).Two studies reported the number of participants with severe or life-threatening bleeding. There was no evidence of any difference in the number of participants with severe or life-threatening bleeding between a standard trigger level and a higher trigger level (two studies; 421 participants; RR 0.99, 95% CI 0.52 to 1.88; low-quality evidence).Only one study reported the time to first bleeding episode. There was no evidence of any difference in the time to the first bleeding episode between a standard trigger level and a higher trigger level (one study; 255 participants; hazard ratio 1.11, 95% CI 0.64 to 1.91; low-quality evidence).Only one study reported on all-cause mortality within 30 days from the start of the study. There was no evidence of any difference in all-cause mortality between standard and higher trigger groups (one study; 255 participants; RR 1.78, 95% CI 0.83 to 3.81; low-quality evidence).Three studies reported on the number of platelet transfusions per participant. Two studies reported on the mean number of platelet transfusions per participant. There was a significant reduction in the number of platelet transfusions per participant in the standard trigger group (two studies, mean difference -2.09, 95% CI -3.20 to -0.99; low-quality evidence).One study reported on the number of transfusion reactions. There was no evidence to demonstrate any difference in transfusion reactions between the standard and higher trigger groups (one study; 79 participants; RR 0.07, 95% CI 0.00 to 1.09).None of the studies reported on quality of life. In people with haematological disorders who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found low-quality evidence that a standard trigger level (10 x 10(9)/L) is associated with no increase in the risk of bleeding when compared to a higher trigger level (20 x 10(9)/L or 30 x 10(9)/L). There was low-quality evidence that a standard trigger level is associated with a decreased number of transfusion episodes when compared to a higher trigger level (20 x 10(9)/L or 30 x 10(9)/L).Findings from this review were based on three studies and 499 participants. Without further evidence, it is reasonable to continue with the current practice of administering prophylactic platelet transfusions using the standard trigger level (10 x 10(9)/L) in the absence of other risk factors for bleeding.

Bleeding disorder education in obstetrics and gynecology residency training: a national survey.

PubMed

Dietrich, Jennifer E; Tran, Xuan G; Giardino, Angelo P

2011-04-01

The purpose of this study was to assess the educational approach to the bleeding disorder evaluation in Obstetrics and Gynecology residency training programs in the continental United States. Information was sought from chief residents regarding training experiences and fund of knowledge regarding the evaluation of menorrhagia and diagnosis of bleeding disorders during their residency. A 24-item questionnaire was sent to the chief residents at 241 non-military Obstetrics and Gynecology residency programs. The study was conducted at Texas Children's Health Plan in Houston, Texas. Chief residents at 241 non-military Obstetrics and Gynecology residency programs. Responses to questionnaires. The overall response rate was 30%. Residents reported training in the medical evaluation of menorrhagia during residency with a mean of 9.1 hours per year in the first year of residency and 11.1 hours/year in the 2(nd), 3(rd) and 4(th) years; 67.7% reported they viewed their training in the medical evaluation of menorrhagia and bleeding disorders as sufficient preparation for clinical practice; and over two thirds reported specific training in common bleeding disorders, such as von Willebrand disease. The current state of training in the evaluation of menorrhagia and bleeding disorders appeared to be mixed regarding the evaluation of dysfunctional uterine bleeding. An area for improvement was identified to better approach best clinical practice in the evaluation of women with menorrhagia and underlying bleeding disorders, which can be guided by the thoughtful approach taken in the recent NHLBI von Willebrand disease guidelines. Copyright © 2011 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Successful Endoscopic Hemostasis Is a Protective Factor for Rebleeding and Mortality in Patients with Nonvariceal Upper Gastrointestinal Bleeding.

PubMed

Han, Yong Jae; Cha, Jae Myung; Park, Jae Hyun; Jeon, Jung Won; Shin, Hyun Phil; Joo, Kwang Ro; Lee, Joung Il

2016-07-01

Rebleeding and mortality rates remain high in patients with nonvariceal upper gastrointestinal bleeding. To identify clinical and endoscopic risk factors for rebleeding and mortality in patients with nonvariceal upper gastrointestinal bleeding. This study was performed in patients with nonvariceal upper gastrointestinal bleeding who underwent upper endoscopic procedures between July 2006 and February 2013. Clinical and endoscopic characteristics were compared among patients with and without rebleeding and mortality. Logistic regression analysis was performed to determine independent risk factors for rebleeding and mortality. After excluding 64 patients, data for 689 patients with nonvariceal upper gastrointestinal bleeding were analyzed. Peptic ulcer (62.6 %) was by far the most common source of bleeding. Endoscopic intervention was performed within 24 h in 99.0 % of patients, and successful endoscopic hemostasis was possible in 80.7 % of patients. The 30-day rebleeding rate was 13.1 % (n = 93). Unsuccessful endoscopic hemostasis was found to be the only independent risk factor for rebleeding (odds ratio 79.6; 95 % confidence interval 37.8-167.6; p = 0.000). The overall 30-day mortality rate was 3.2 % (n = 23). Unsuccessful endoscopic hemostasis (odds ratio 4.9; 95 % confidence interval 1.7-13.9; p = 0.003) was also associated with increased 30-day mortality in patients with nonvariceal upper gastrointestinal bleeding. Successful endoscopic hemostasis is an independent protective factor for both rebleeding and mortality in patients with nonvariceal upper gastrointestinal bleeding.

Management and Outcomes of Bleeding Events in Patients in the Emergency Department Taking Warfarin or a Non-Vitamin K Antagonist Oral Anticoagulant.

PubMed

Singer, Adam J; Quinn, Adam; Dasgupta, Neil; Thode, Henry C

2017-01-01

Most comparisons of bleeding patients who are taking warfarin or a non-vitamin K oral anticoagulant (NOAC) have been limited to admitted patients and major bleeding events in well-controlled, clinical trial settings. We describe the clinical characteristics, interventions, and outcomes in patients who are taking warfarin or a NOAC who presented to the emergency department (ED) with any bleeding event. We conducted a structured, retrospective, observational study of nonvalvular atrial fibrillation, pulmonary embolism, or deep vein thrombosis warfarin- or NOAC-treated patients presenting with any bleeding event to a large, academic ED between January 2012 and March 2015. We used descriptive statistics to summarize baseline characteristics, treatments, and outcomes and performed subgroup analyses based on the type of anticoagulant and site of bleeding. The electronic search yielded 95 cases of patients taking a NOAC (i.e., dabigatran [33], rivaroxaban [32], or abixaban [30]) and 342 patients taking warfarin. Reversal agents were rarely used in all anticoagulant groups. Case fatality rates were similar among warfarin- and NOAC-treated patients for gastrointestinal bleeding (7% vs. 7%) and intracranial hemorrhage (18% vs. 4%), respectively. After adjustment for other factors, only intracranial hemorrhage (odds ratio 4.4; 95% confidence interval 1.4-13.3) was associated with mortality. Despite the rare use of reversal strategies, mortality was low and outcomes were comparable among patients with bleeding events presenting to the ED while taking a NOAC compared with warfarin. Copyright © 2016 Elsevier Inc. All rights reserved.

Body mass index trumps age in decision for endometrial biopsy: cohort study of symptomatic premenopausal women.

PubMed

Wise, Michelle R; Gill, Premjit; Lensen, Sarah; Thompson, John M D; Farquhar, Cynthia M

2016-11-01

Clinical guidelines recommend that women with abnormal uterine bleeding with risk factors have an endometrial biopsy to exclude hyperplasia or cancer. Given the majority of endometrial cancer occurs in postmenopausal women, it has not been widely recognized that obesity is a significant risk factor for endometrial hyperplasia and cancer in young, symptomatic, premenopausal women. We sought to evaluate the effect of body mass index on risk of endometrial hyperplasia or cancer in premenopausal women with abnormal uterine bleeding. This was a retrospective cohort study in a single large urban secondary women's health service. Participants were 916 premenopausal women referred for abnormal uterine bleeding of any cause and had an endometrial biopsy from 2008 through 2014. The primary outcome was complex endometrial hyperplasia (with or without atypia) or endometrial cancer. Almost 5% of participants had complex endometrial hyperplasia or cancer. After adjusting for clinical and demographic factors, women with a measured body mass index ≥30 kg/m 2 were 4 times more likely to develop complex hyperplasia or cancer (95% confidence interval, 1.36-11.74). Other risk factors were nulliparity (adjusted odds ratio, 3.08; 95% confidence interval, 1.43-6.64) and anemia (adjusted odds ratio, 2.23; 95% confidence interval, 1.14-4.35). Age, diabetes, and menstrual history were not significant. Obesity is an important risk factor for complex endometrial hyperplasia or cancer in premenopausal women with abnormal uterine bleeding who had an endometrial biopsy in a secondary gynecology service. As over half of women with the outcome in this study were age <45 years, deciding to biopsy primarily based on age, as currently recommended in national guidelines, potentially misses many cases or delays diagnosis. Body mass index should be the first stratification in the decision to perform endometrial biopsy and/or to refer secondary gynecology services. Copyright © 2016 Elsevier Inc. All rights reserved.

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.

PubMed

Weitz, Jeffrey I; Lensing, Anthonie W A; Prins, Martin H; Bauersachs, Rupert; Beyer-Westendorf, Jan; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Decousus, Hervé; Freitas, Maria C S; Holberg, Gerlind; Kakkar, Ajay K; Haskell, Lloyd; van Bellen, Bonno; Pap, Akos F; Berkowitz, Scott D; Verhamme, Peter; Wells, Philip S; Prandoni, Paolo

2017-03-30

Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).

Efficacy of Over-the-Scope Clips in Management of High-Risk Gastrointestinal Bleeding.

PubMed

Brandler, Justin; Baruah, Anushka; Zeb, Muhammad; Mehfooz, Ayesha; Pophali, Prachi; Wong Kee Song, Louis; AbuDayyeh, Barham; Gostout, Christopher; Mara, Kristin; Dierkhising, Ross; Buttar, Navtej

2018-05-01

Standard endoscopic therapies do not control bleeding or produce complications in as many as 20% of patients with nonvariceal gastrointestinal bleeding. Most bleeding comes from ulcers with characteristics such as high-risk vascular territories and/or large vessels. We evaluated the efficacy of using over-the-scope clips (OTSCs) as primary or rescue therapy for patients with bleeding from lesions that have a high risk for adverse outcomes. We performed a retrospective analysis of data from 67 patients with gastrointestinal bleeding from high-risk lesions who were treated with OTSCs as primary (n = 49) or rescue therapy (n = 18) at a quaternary center, from December 2011 through February 2015. The definition of high-risk lesions was lesions that were situated in the area of a major artery and larger than 2 mm in diameter and/or a deep penetrating, excavated, fibrotic ulcer with high-risk stigmata, in which a perforation could not be ruled out or thermal therapy would cause perforation, or lesions that could not be treated by standard endoscopy. Clinical severity was determined based on the Rockall score and a modified Blatchford score. Our primary outcome was the incidence of rebleeding within 30 days after OTSC placement. We assessed risk factors for rebleeding using univariate hazard models followed by multivariable analysis. Of the 67 patients, 47 (70.1%) remained free of rebleeding at 30 days after OTSC placement. We found no difference in the proportion of patients with rebleeding who received primary or rescue therapy (hazard ratio, 0.639; 95% confidence interval, 0.084-4.860; P = .6653). Only 9 rebleeding events were linked clearly to OTSCs and required intervention, indicating an OTSC success rate of 81.3%. We found no significant associations between rebleeding and clinical scores. However, on multivariable analysis, patients with coronary artery disease had a higher risk of rebleeding after OTSC independent of international normalized ratio and antiplatelet use (hazard ratio, 7.30; P = .0002). In a retrospective analysis of 67 patients with bleeding from high-risk gastrointestinal lesions, we found OTSCs to prevent rebleeding in more than 80% of cases. In the past, these lesions were treated with surgical or radiologic interventions. Patients with coronary artery disease have an increased risk of rebleeding after OTSCs, suggesting the need for escalated therapies. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Meta-analysis of five photodisinfection clinical trials for periodontitis

NASA Astrophysics Data System (ADS)

Andersen, Roger C.; Loebel, Nicolas G.; Andersen, Dane M.

2009-06-01

Photodynamic therapy(PDT) has been demonstrated to effectively kill human periopathogens in vitro. To evaluate the efficacy of PDT in vivo a series of clinical trials was carried out in multiple centers and populations. Clinical parameters including clinical attachment level, pocket probing depth and bleeding on probing were all evaluated. All groups received the standard of care, scaling and root planing, and the treatment group additionally received a single treatment of PDT. Of the total 309 patients and over 40,000 pockets treated in these 5 trials it was determined that photodynamic therapy provided a statistically significant improvement in clinical parameters over scaling and root planing alone.

The efficacy and safety of novel oral anticoagulants for the preventive treatment in atrial fibrillation patients: a systematic review and meta-analysis.

PubMed

Liu, Guang Jian; Wang, Yun Fu; Chen, Ping You; Chang, Wei; Tu, Ming Li; Chang, Li Ying; Cheng, Ping; Luo, Jie

2014-09-01

Novel oral anticoagulants, including direct factor Xa inhibitors and direct factor IIa inhibitors, have been used to prevent stroke in patients with atrial fibrillation (AF) for a decade. In this study, the efficacy and safety of the novel oral anticoagulants were assessed in AF patients. No language restrictions were applied. Study selection and data extraction were carried out by searching PubMed, EMBASE, OVID, the BIOSIS, the Web of Science, Clinical Trials Registers, Cochrane Central Register of Controlled Trials and the China Academic Library and Information System. Each database was searched from its inception date to June 2013. Using odds ratio (OR) as an indicator, we systematically evaluated the primary efficacy endpoints and safety endpoints, as well as 10 secondary endpoints. Compared to the control drugs, the novel oral anticoagulants showed an OR decreased by 26% (OR: 0.74, 95% confidence interval (CI): 0.62-0.88) for stroke or systemic embolism, decreased by 24% (OR: 0.76, 95% CI: 0.64-0.90) for major bleeding, decreased by 10% (OR: 0.90, 95% CI: 0.84-0.95) for death from any cause, decreased by 27% for disabling or fatal stroke (OR: 0.73, 95% CI: 0.54-0.97), decreased by 31% (OR: 0.69, 95% CI: 0.60-0.8) for fatal bleeding, and decreased by 8% (OR: 0.92, 95% CI: 0.88-0.95) for serious adverse events. However, there was no significant difference in acute myocardial infarction, systemic embolism, major bleeding or clinically relevant non-major, all bleeding events, all adverse events and liver function disorder, between the novel oral anticoagulants and control drugs (p > 0.05). Compared to the control drugs, the novel oral anticoagulants showed higher efficiency and safety in patients with AF, as evidenced by their superior performance not only in reducing the risk of stroke or systemic embolism with a lower risk of major bleeding but also in decreasing the incidence of death from any cause, disabling or fatal stroke, serious adverse events and fatal bleeding.

Factors Associated with Acute and Chronic Hydrocephalus in Nonaneurysmal Subarachnoid Hemorrhage.

PubMed

Kang, Peter; Raya, Amanda; Zipfel, Gregory J; Dhar, Rajat

2016-02-01

Hydrocephalus requiring external ventricular drain (EVD) or shunt placement commonly complicates aneurysmal subarachnoid hemorrhage (SAH), but its frequency is not as well known for nonaneurysmal SAH (NA-SAH). Those with diffuse bleeding may have greater risk of hydrocephalus compared to those with a perimesencephalic pattern. We evaluated the frequency of hydrocephalus in NA-SAH and whether imaging factors could predict the need for EVD and shunting. We collected admission clinical and imaging variables for 105 NA-SAH patients, including bicaudate index (BI), Hijdra sum score (HSS), intraventricular hemorrhage (IVH) score, modified Fisher scale (mFS), and bleeding pattern. Hydrocephalus was categorized as acute (need for EVD) or chronic (shunt). We applied logistic regression to determine whether hydrocephalus risk was independently related to bleeding pattern or mediated through blood volume or ventriculomegaly. Acute hydrocephalus was seen in 26 (25%) patients but was more common with diffuse (15/28, 54%) versus perimesencephalic (10/59, 17%, p < 0.001) bleeding. Patients developing acute hydrocephalus had worse clinical grade and higher BI, HSS, and IVH scores. Adjusting the relationship between hydrocephalus and diffuse bleeding for HSS (but not BI) nullified this association. Nine (35%) patients requiring EVD eventually required shunting for chronic hydrocephalus, which was associated with greater blood burden but not poor clinical grade. Acute hydrocephalus occurs in one-quarter of NA-SAH patients. The greater risk in diffuse bleeding appears to be mediated by greater cisternal blood volume but not by greater ventriculomegaly. Imaging characteristics may aid in anticipatory management of hydrocephalus in NA-SAH.

Warfarin-drug interactions: An emphasis on influence of polypharmacy and high doses of amoxicillin/clavulanate.

PubMed

Abdel-Aziz, Mahmoud I; Ali, Mostafa A Sayed; Hassan, Ayman K M; Elfaham, Tahani H

2016-01-01

The objective of this study was to investigate the effect of polypharmacy and high doses of amoxicillin/clavulanate on warfarin response in hospitalized patients. This was a prospective cross-sectional observational study on 120 patients from July 2013 to January 2014. Potentially interacting drugs were classified according to their tendency of increasing international normalized ratio (INR) or bleeding risk. The 87.5% of patients prescribed high-dose amoxicillin/clavulanate (10-12 g daily) compared with 28.9% of patients prescribed a normal dose (up to 3.6 g daily) had INR values ≥ 4 during the hospital stay (P ≤ .001). Increased number of potentially interacting drugs that are known to increase INR was a significant predictor of having INR values ≥ 4 (OR, 2.5; 95%CI, 1.3-4.7), and increased number of potentially interacting drugs that are known to increase bleeding risk was a significant predictor of experiencing bleeding episodes (OR, 3.1; 95%CI, 1.3-7.3). High doses of amoxicillin/clavulanate were associated with a higher risk of over-anticoagulation when combined with warfarin than were normal doses. Increased risk of having INR ≥ 4 and bleeding events was associated with increased numbers of potentially interacting drugs prescribed, indicating that polypharmacy is a problem of concern. Frequent monitoring of warfarin therapy along with patients' medications is necessary to avoid complications. © 2015, The American College of Clinical Pharmacology.

Postoperative gastrointestinal bleeding after an orthotopic liver transplant: a single-center experience.

PubMed

Fidan, Cihan; Kırnap, Mahir; Akdur, Aydıncan; Özçay, Figen; Selçuk, Haldun; Arslan, Gülnaz; Moray, Gökhan; Haberal, Mehmet

2014-03-01

The overall incidence, causes, and treatment of posttransplant gastrointestinal bleeding, have been previously described. In this study, we examined the causes and treatment of postoperative gastrointestinal bleeding after orthotopic liver transplant. Clinical data of 335 patients who underwent an orthotopic liver transplant at our institution between September 2001 and December 2012 were analyzed retrospectively. The diagnosis and treatment of postoperative gastrointestinal bleeding after an orthotopic liver transplant were reviewed. Gastrointestinal bleeding occurred in 13 patients (3.8%) after an orthotopic liver transplant. Five patients (38.4%) were adult and 8 patients (61.6%) were pediatric. The sites of the bleeding were Roux-en-Y anastomosis bleeding in 5 cases, peptic ulcer in 3 cases, erosive gastritis in 3 cases, gastric and esophageal varices in 1 case, and hemobilia in 1 case. These 13 patients with gastrointestinal bleeding were managed with conservative treatment, endoscopic treatment, radiologic interventional embolism, or exploratory laparotomy. No patients died because of gastro--intestinal bleeding. During follow-up, 4 patients died because of sepsis and 1 patient died of recurrence of hepatocellular carcinoma. Gastrointestinal bleeding after liver transplant and its incidence, causes, and treatment are not well-described in the literature. Diagnosis and management of gastrointestinal bleeding requires a multidisciplinary approach involving surgeons, hepatologists, advanced and experienced endoscopists, and interventional radiologists.

Development and validation of a prognostic model to predict death in patients with traumatic bleeding, and evaluation of the effect of tranexamic acid on mortality according to baseline risk: a secondary analysis of a randomised controlled trial.

PubMed

Perel, P; Prieto-Merino, D; Shakur, H; Roberts, I

2013-06-01

Severe bleeding accounts for about one-third of in-hospital trauma deaths. Patients with a high baseline risk of death have the most to gain from the use of life-saving treatments. An accurate and user-friendly prognostic model to predict mortality in bleeding trauma patients could assist doctors and paramedics in pre-hospital triage and could shorten the time to diagnostic and life-saving procedures such as surgery and tranexamic acid (TXA). The aim of the study was to develop and validate a prognostic model for early mortality in patients with traumatic bleeding and to examine whether or not the effect of TXA on the risk of death and thrombotic events in bleeding adult trauma patients varies according to baseline risk. Multivariable logistic regression and risk-stratified analysis of a large international cohort of trauma patients. Two hundred and seventy-four hospitals in 40 high-, medium- and low-income countries. We derived prognostic models in a large placebo-controlled trial of the effects of early administration of a short course of TXA [Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial]. The trial included 20,127 trauma patients with, or at risk of, significant bleeding, within 8 hours of injury. We externally validated the model on 14,220 selected trauma patients from the Trauma Audit and Research Network (TARN), which included mainly patients from the UK. We examined the effect of TXA on all-cause mortality, death due to bleeding and thrombotic events (fatal and non-fatal myocardial infarction, stroke, deep-vein thrombosis and pulmonary embolism) within risk strata in the CRASH-2 trial data set and we estimated the proportion of premature deaths averted by applying the odds ratio (OR) from the CRASH-2 trial to each of the risk strata in TARN. For the stratified analysis according baseline risk we considered the intervention TXA (1 g over 10 minutes followed by 1 g over 8 hours) or matching placebo. For the prognostic models we included predictors for death in hospital within 4 weeks of injury. For the stratified analysis we reported ORs for all causes of death, death due to bleeding, and fatal and non-fatal thrombotic events associated with the use of TXA according to baseline risk. A total of 3076 (15%) patients died in the CRASH-2 trial and 1705 (12%) in the TARN data set. Glasgow Coma Scale score, age and systolic blood pressure were the strongest predictors of mortality. Discrimination and calibration were satisfactory, with C-statistics > 0.80 in both CRASH-2 trial and TARN data sets. A simple chart was constructed to readily provide the probability of death at the point of care, while a web-based calculator is available for a more detailed risk assessment. TXA reduced all-cause mortality and death due to bleeding in each stratum of baseline risk. There was no evidence of heterogeneity in the effect of TXA on all-cause mortality (p-value for interaction = 0.96) or death due to bleeding (p= 0.98). There was a significant reduction in the odds of fatal and non-fatal thrombotic events with TXA (OR = 0.69, 95% confidence interval 0.53 to 0.89; p= 0.005). There was no evidence of heterogeneity in the effect of TXA on the risk of thrombotic events (p= 0.74). This prognostic model can be used to obtain valid predictions of mortality in patients with traumatic bleeding. TXA can be administered safely to a wide spectrum of bleeding trauma patients and should not be restricted to the most severely injured. Future research should evaluate whether or not the use of this prognostic model in clinical practice has an impact on the management and outcomes of trauma patients.

The use of recombinant factor VIIa in a patient with Noonan syndrome and life-threatening bleeding.

PubMed

Tofil, Nancy M; Winkler, Margaret K; Watts, Raymond G; Noonan, Jacqueline

2005-05-01

To present a case report of a patient with Noonan syndrome who developed life-threatening gastrointestinal bleeding shortly after cardiac surgery that was successfully treated with recombinant factor VIIa. Case report. Pediatric intensive care unit of a children's hospital. Ten-month-old with Noonan syndrome and massive gastrointestinal bleeding resulting in severe hypovolemic shock. Recombinant factor VIIa was used in this patient's severe bleeding associated with Noonan syndrome after no other supportive measures were successful. Recombinant Factor VIIa significantly decreased the patient's bleeding and allowed his hypovolemic shock to improve. Ultimately, the patient made a complete recovery. Noonan syndrome has a constellation of both cardiac and noncardiac malformations including an increased risk of bleeding, and recombinant factor VIIa is an important agent in the treatment of significant bleeding.

An Eight-Week Clinical Evaluation of an Oscillating-Rotating Power Toothbrush with a Brush Head Utilizing Angled Bristles Compared with a Sonic Toothbrush in the Reduction of Gingivitis and Plaque.

PubMed

Ccahuana-Vasquez, Renzo A; Conde, Erinn; Grender, Julie M; Cunningham, Pamela; Qaqish, Jimmy; Goyal, C Ram

2015-01-01

To evaluate and compare the efficacy of an oscillating-rotating (O-R) power toothbrush with a brush head utilizing angled bristles to a marketed sonic toothbrush in the reduction of plaque and gingivitis over an eight-week period. This study used a randomized, examiner-blind, single-center, two-treatment, parallel group, eight-week design. Subjects with mild-to-moderate plaque and gingivitis were evaluated for baseline whole mouth, gingival margin, and approximal plaque, gingivitis, and gingival bleeding. Clinical assessments were performed using the Modified Gingival Index, Gingival Bleeding Index, and the Rustogi Modified Navy Plaque Index. Subjects received either the O-R brush (Oral-B Professional Care 1000 [D16u] with Oral-B CrossAction brush head [EB50]) or the sonic brush (Sonicare DiamondClean with the standard DiamondClean brush head). Subjects brushed twice daily for two minutes per brushing with the assigned brush and a standard fluoride dentifrice for eight weeks before returning for plaque and gingivitis evaluations using the same methods. Prior to baseline and Week 8 measurements, participants abstained from oral hygiene for 12 hours. One hundred and forty-eight subjects completed the study; 75 in the O-R group and 73 in the sonic group. Both brushes demonstrated statistically significant reductions in plaque and gingivitis over the eight-week study period (p < 0.00 1). The O-R brush was statistically significantly more effective in reducing plaque and gingivitis than the sonic brush. Whole mouth, gingival margin, and approximal plaque reductions were 27.7%, 46.8%, and 29.3% greater, respectively, compared with the sonic brush, while the reductions in gingivitis, gingival bleeding, and number of bleeding sites were 34.6%, 36.4%, and 36.1% greater, respectively, for the O-R brush than for the sonic brush (p < 0.001 for all six measures). No adverse events were observed for either brush. The plaque and gingivitis reductions for the O-R power brush incorporating the angled-bristled brush head were significantly greater than for the sonic power brush.

Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction) analysis.

PubMed

Antman, Elliott M; Wiviott, Stephen D; Murphy, Sabina A; Voitk, Juri; Hasin, Yonathan; Widimsky, Petr; Chandna, Harish; Macias, William; McCabe, Carolyn H; Braunwald, Eugene

2008-05-27

We evaluated the relative contributions of the loading and maintenance doses of prasugrel on events in a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction) analysis. Prasugrel is superior to clopidogrel in preventing ischemic events in patients with an acute coronary syndrome who are undergoing percutaneous coronary intervention, but it is associated with an increased risk of major bleeding. Landmark analyses for efficacy, safety, and net clinical benefit were performed from randomization to day 3 and from day 3 to the end of the trial. Significant reductions in ischemic events, including myocardial infarction, stent thrombosis, and urgent target vessel revascularization, were observed with the use of prasugrel both during the first 3 days and from 3 days to the end of the trial. Thrombolysis In Myocardial Infarction major non-coronary artery bypass graft bleeding was similar to clopidogrel during the first 3 days but was significantly greater with the use of prasugrel from 3 days to the end of the study. Net clinical benefit significantly favored prasugrel both early and late in the trial. Both the loading dose and maintenance dose of prasugrel were superior to clopidogrel for the reduction of ischemic events. This result emphasizes the importance of maintaining high levels of inhibition of platelet aggregation via P2Y(12) receptor inhibition, not only for the prevention of periprocedural ischemic events but also during long-term follow-up. The excess major bleeding observed with the use of prasugrel occurred predominantly during the maintenance phase. Approaches to reduce the relative excess of bleeding with prasugrel should focus on the maintenance dose (e.g., reduction in maintenance dose in previously reported high-risk subgroups, such as the elderly and those patients with low body weight). (A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention; NCT00097591).

Management of overt upper gastrointestinal bleeding in a low resource setting: a real world report from Nigeria.

PubMed

Alatise, Olusegun I; Aderibigbe, Adeniyi S; Adisa, Adewale O; Adekanle, Olusegun; Agbakwuru, Augustine E; Arigbabu, Anthony O

2014-12-10

Upper gastrointestinal bleeding (UGIB) remains a common medical problem worldwide that has significant associated morbidity, mortality, and health care resource use. This study outlines the aetiology, clinical presentation, and treatment outcomes of patients with UGIB in a Nigerian low resource health facility. This was a descriptive study of consecutive patients who underwent upper gastrointestinal (GI) endoscopy for upper GI bleeding in the endoscopy unit of the Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Osun State, Nigeria from January 2007 to December 2013. During the study period, 287 (12.4%) of 2,320 patients who underwent upper GI endoscopies had UGIB. Of these, 206 (72.0%) patients were males and their ages ranged from 3 to 100 years with a median age of 49 years. The main clinical presentation included passage of melaena stool in 268 (93.4%) of individuals, 173 (60.3%) had haematemesis, 110 (38.3%) had haematochezia, and 161 (56.1%) were dizzy at presentation. Observed in 88 (30.6%) of UGIB patients, duodenal ulcer was the most common cause, followed by varices [52 (18.1%)] and gastritis [51 (17.1%)]. For variceal bleeding, 15 (28.8%) and 21 (40.4%) of patients had injection sclerotherapy and variceal band ligation, respectively. The overall rebleeding rate for endoscopic therapy for varices was 16.7%. For patients with ulcers, only 42 of 55 who had Forrest grade Ia to IIb ulcers were offered endoscopic therapy. Endoscopic therapy was áin 90.5% of the cases. No rebleeding followed endoscopic therapy for the ulcers. The obtained Rockall scores ranged from 2 to 10 and the median was 5.0. Of all patients, 92.7% had medium or high risk scores. An increase in Rockall score was significantly associated with length of hospital stay and mortality (p < 0.001). The overall mortality rate was 5.9% (17 patients). Endoscopic therapy for UGIB in a resource-poor setting such as Nigeria is feasible, significantly reduces morbidity and mortality, and is cost effective. Efforts should be made to improve the accessibility of these therapeutic procedure for patients with UGIB in Nigeria.

The effectiveness of steroids for edema, ecchymosis, and intraoperative bleeding in rhinoplasty.

PubMed

Koc, Sema; Gürbüzler, Levent; Yaman, Hüseyin; Eyibilen, Ahmet; Süren, Mustafa; Kaya, Ziya; Yelken, Kursat; Aladağ, Ibrahim

2011-01-01

The aim of this study was to investigate the dose-related effectiveness of steroids on periorbital edema, ecchymosis, and intraoperative bleeding in patients who underwent open rhinoplasty with osteotomy. Forty patients were divided into three groups: those in group 1 (n = 15) were given a single dose of 1-mg/kg intravenous (i.v.) methylprednisolone, those in group 2 (n = 15) were given a single dose of 3-mg/kg i.v. methylprednisolone preoperatively, and group 3 (n = 10) was the control group. Eyelid edema and periorbital soft-tissue ecchymosis were evaluated separately using a scale of 0-4. In groups using the steroid preoperatively, periorbital edema and ecchymosis were significantly lower compared with the control group (p < 0.05). No significant differences were seen clinically or statistically in preventing or reducing either the periorbital ecchymosis or the periorbital edema between groups 1 and 2. Also, there was no significant difference among the groups in terms of bleeding (p > 0.05). No complications with regard to the operation or steroid use were observed. Our results support that steroids significantly decrease periorbital ecchymosis and periorbital edema in open rhinoplasty with osteotomy. Additionally, our results suggest that if the dose of steroids is adjusted according to body weight, there is no significant benefit in a single dose of 3 mg/kg of methylprednisolone over a lower dose of 1 mg/kg and there is no need for higher doses of methylprednisolone administration.

Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial.

PubMed

Jairath, Vipul; Kahan, Brennan C; Gray, Alasdair; Doré, Caroline J; Mora, Ana; James, Martin W; Stanley, Adrian J; Everett, Simon M; Bailey, Adam A; Dallal, Helen; Greenaway, John; Le Jeune, Ivan; Darwent, Melanie; Church, Nicholas; Reckless, Ian; Hodge, Renate; Dyer, Claire; Meredith, Sarah; Llewelyn, Charlotte; Palmer, Kelvin R; Logan, Richard F; Travis, Simon P; Walsh, Timothy S; Murphy, Michael F

2015-07-11

Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding. In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532. Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in the restrictive policy vs 83% (25) in the liberal policy (difference 14%; 95% CI 7-21; p=0·005). Mean last recorded haemoglobin concentration was 116 (SD 24) g/L for patients on the restrictive policy and 118 (20) g/L for those on the liberal policy (difference -2·0 [95% CI -12·0 to 7·0]; p=0·50). Fewer patients received RBCs on the restrictive policy than on the liberal policy (restrictive policy 133 [33%] vs liberal policy 247 [46%]; difference -12% [95% CI -35 to 11]; p=0·23), with fewer RBC units transfused (mean 1·2 [SD 2·1] vs 1·9 [2·8]; difference -0·7 [-1·6 to 0·3]; p=0·12), although these differences were not significant. We noted no significant difference in clinical outcomes. A cluster randomised design led to rapid recruitment, high protocol adherence, separation in degree of anaemia between groups, and non-significant reduction in RBC transfusion in the restrictive policy. A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding. NHS Blood and Transplant Research and Development. Copyright © 2015 Elsevier Ltd. All rights reserved.

Recurrent coagulopathy with delayed significant bleeding after crotaline envenomation.

PubMed

O'Brien, Nicole F; DeMott, Megan C; Suchard, Jeffrey R; Clark, Richard F; Peterson, Bradley M

2009-07-01

Report of delayed significant coagulopathy, thrombocytopenia, and bleeding after Crotaline envenomation. Recurrent coagulopathy and thrombocytopenia have been described after treatment of Crotaline envenomation with Crotalidae polyvalent immune Fab (CroFab). Until now, there have been no reports of significant spontaneous bleeding despite these abnormalities. Crotalidae polyvalent immune Fab has a relatively short half-life compared with previous antivenoms used to treat snake bite. This shorter half-life allows for recurrence of venom effects. Therefore, patients with Crotaline envenomation should undergo close monitoring for recurrence of coagulopathy or thrombocytopenia after treatment with CroFab. If coagulopathy or thrombocytopenia recurs, retreatment with CroFab should be considered to prevent significant bleeding.

Hermansky-Pudlak Syndrome: A Case Report

PubMed Central

Berber, Ilhami; Erkurt, Mehmet Ali; Kuku, Irfan; Kaya, Emin; Koroglu, Mustafa; Gul, Mehmet; Bentli, Recep

2014-01-01

Objective. The aim of this paper is to report the case of a patient diagnosed with Hermansky-Pudlak syndrome, as a result of bleeding diathesis. Clinical Presentation and Intervention. A 23-year-old male presented with recurrent epistaxis and, upon physical examination, was found to be remarkable for albinism and suborbital ecchymosis. The absence of dense bodies in the platelets was demonstrated using electron microscopy. This patient was (slowly) administered one unit of a platelet suspension, and his bleeding decreased considerably. Conclusion. This case shows that Hermansky-Pudlak syndrome should be considered in the differential diagnosis of a patient presenting with bleeding diathesis, when the clinical presentation also includes oculocutaneous albinism and visual problems. PMID:24707413

Practical considerations in emergency management of bleeding in the setting of target-specific oral anticoagulants.

PubMed

Miller, Michael P; Trujillo, Toby C; Nordenholz, Kristen E

2014-04-01

The recent arrival of the target-specific oral anticoagulants (TSOACs) offers potential advantages in the field of anticoagulation. However, there are no rapid and accurate and routinely available laboratory assays to evaluate their contribution to clinical bleeding. With the expanding clinical indications for the TSOACs, and the arrival of newer reversal agents on the market, the emergency clinician will need to be familiar with drug specifics as well as methods for anticoagulation reversal. This review offers a summary of the literature and some practical strategies for the approach to the patient taking TSOACs and the management of bleeding in these cases. Copyright © 2014 Elsevier Inc. All rights reserved.

Fish oil LC-PUFAs do not affect blood coagulation parameters and bleeding manifestations: Analysis of 8 clinical studies with selected patient groups on omega-3-enriched medical nutrition.

PubMed

Jeansen, Stephanie; Witkamp, Renger F; Garthoff, Jossie A; van Helvoort, Ardy; Calder, Philip C

2018-06-01

The increased consumption of fish oil enriched-products exposes a wide diversity of people, including elderly and those with impaired health to relatively high amounts of n-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFAs). There is an ongoing debate around the possible adverse effects of n-3 LC-PUFAs on bleeding risk, particularly relevant in people with a medical history of cardiovascular events or using antithrombotic drugs. This analysis of 8 clinical intervention studies conducted with enteral medical nutrition products containing fish oil as a source of n-3 LC-PUFAs addresses the occurrence of bleeding-related adverse events and effects on key coagulation parameters (Prothrombin Time [PT], (activated) and Partial Thromboplastin Time [(a)PTT]). In all the patients considered (over 600 subjects treated with the active product in total), with moderate to severe disease, with or without concomitant use of antithrombotic agents, at home or in an Intensive Care Unit (ICU), no evidence of increased risk of bleeding with use of n-3 LC-PUFAs was observed. Furthermore there were no statistically significant changes from baseline in measured coagulation parameters. These findings further support the safe consumption of n-3 LC-PUFAs, even at short-term doses up to 10 g/day of eicosapentaenoic acid + docosahexaenoic acid (EPA + DHA) or consumed for up to 52 weeks above 1.5 g/day, in selected vulnerable and sensitive populations such as subjects with gastrointestinal cancer or patients in an ICU. We found no evidence to support any concern raised with regards to the application of n-3 LC-PUFAs and the potentially increased risk for the occurrence of adverse bleeding manifestations in these selected patient populations consuming fish oil enriched medical nutrition. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Clinical effectiveness of multiple-drug injection treatment in unruptured ectopic pregnancies: a retrospective study.

PubMed

Dai, Quan; Wang, Lu-Lu; Shao, Xiao-Hui; Wang, Si-Ming; Dong, Xiao-Qiu

2012-10-01

To study the effect of local interventional treatment of unruptured ectopic pregnancies with multiple-drug injection guided by color Doppler sonography. In this retrospective analysis, 49 patients with an unruptured ectopic pregnancy were treated with two different local injection methods administered under sonographic guidance. The patients were divided into single-drug (n = 23) and multiple-drug (n = 26) injection groups, and they received a locally administered injection of methotrexate alone or a combination including methotrexate, hemocoagulase, antibiotics, and anti-inflammatory drugs, respectively. Overall, local injection treatment was successful in 44 patients. The 5 patients with failed treatment underwent laparotomy about 1 week after single-drug injection. Serum β-human chorionic gonadotropin (β-hCG ) levels, ectopic pregnancy mass sizes, blood flow at various points after treatment, the incidence of pelvic bleeding, and the time for serum β-hCG levels to return to normal and the mass to resolve were analyzed in the remaining 44 patients. Single-drug treatment was successful in 18 patients; 10 of 23 had low to moderate pelvic bleeding after treatment, and 5 were referred for surgery. All 26 patients were successfully treated by multiple-drug injection. Only 2 patients had a small amount of pelvic bleeding. Differences between groups were statistically significant (P < .05) for surgery rates, the incidence of pelvic bleeding, transient increases in serum β-hCG levels, mean days to normal β-hCG levels, mean days of mass resolution, and mean mass diameters 1 to 6 weeks after treatment. Local multiple-drug injection under color Doppler guidance is a new, safe, and effective method for treating unruptured ectopic pregnancies. It accelerates the serum β-hCG decline and facilitates mass resolution. This regimen is associated with a very low rate of pelvic bleeding, improves the success rate of conservative treatment, and, therefore, has value as an important clinical application.

[Administration of activated recombinant factor VII (novo seven) for the control of massive bleeding in gynecology].

PubMed

Tanchev, S; Pandurski, F; Georgiev, A; Gesheva, Iu; Platikanov, V; Dinov, P

2004-01-01

We report our clinical opinion for recombinant activated factor VII (NovoSeven, Novo Nordisk, Copenhagen, Denmark) administration in gynecology patients with massive haemorrhage. 3 women with gynecology deseases and severe bleeding in recieved NovoSeven in bolus IV. The blood loss and laboratory changes in hematology and haemostasis parameters are monitored. The bleeding was ceased in all cases. Decrease in values of Hb, Er and PTT was noted. The use of recombinant factor VIIA in gynecology patients with severe bleeding is effective and safe enough and could be an alternative to the extreme surgical procedures.

Heparin as a pharmacologic intervention to induce positive scintiscan in occult gastrointestinal bleeding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chaudhuri, T.K.; Brantly, M.

1984-04-01

The value of using heparin as a pharmacologic intervention to induce a positive scintiscan was studied in a patient with chronic occult gastrointestinal bleeding. When all standard diagnostic tests (upper and lower gastrointestinal series, upper and lower endoscopy, and conventional noninterventional Tc-99m RBC imaging) fail to detect and localize gastrointestinal bleeding in a patient who has definite clinical evidence (guaiac positive stool and dropping hemoglobin, hematocrit) of chronic occult gastrointestinal oozing, heparin may be used (with proper precaution) as a last resort to aid in the scintigraphic detection and localization of chronic occult gastrointestinal bleeding.

Cost comparison of continued anticoagulation with rivaroxaban versus placebo based on the 1-year EINSTEIN-Extension trial efficacy and safety results.

PubMed

Wells, Philip S; Lensing, Anthonie W A; Haskell, Lloyd; Levitan, Bennett; Laliberté, François; Durkin, Michael; Ashton, Veronica; Xiao, Yongling; Crivera, Concetta; Lejeune, Dominique; Schein, Jeff; Lefebvre, Patrick

2018-06-01

The EINSTEIN-Extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (vs placebo) after 6-12 months of initial anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small non-significant increased risk of major bleeding (none fatal or in critical site). This study aimed to compare total healthcare cost between rivaroxaban and placebo, based on the EINSTEIN-EXT event rates. Total healthcare cost was calculated as the sum of treatment and clinical event costs from a US managed care perspective. Treatment duration and event rates were obtained from the EINSTEIN-EXT study. Adjustment on treatment duration was made by assuming a 10% non-adherence rate. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e. recurrent deep vein thrombosis [DVT], recurrent pulmonary embolism, major bleeding, clinically relevant non-major bleeding) were determined from the literature. Results were examined over a ±20% range of each cost component and over 95% confidence intervals (CIs) of event rate differences in deterministic (one-way) and probabilistic sensitivity analyses (PSA). Total healthcare cost was $1,454 lower for rivaroxaban-treated (vs placebo-treated) patients in the base-case, with a lower clinical event cost fully offsetting drug cost. The cost savings of recurrent DVT alone (-$3,102) was greater than drug cost ($2,723). Total healthcare cost remained lower for rivaroxaban in the majority (73%) of PSA (cost difference [95% CI] = -$1,454 [-$2,396, $1,231]). This study was conducted over the 1-year observation period of the EINSTEIN-EXT trial, which limited "real-world" applicability and examination of long-term economic impact. Assumptions on drug and clinical event costs were US-based and, thus, not applicable to other healthcare systems. Total healthcare costs were estimated to be lower for patients continuing rivaroxaban therapy compared to those receiving placebo in VTE patients who had completed 6-12 months of VTE treatment.

Implementation of a Multidisciplinary Bleeding and Transfusion Protocol Significantly Decreases Perioperative Blood Product Utilization and Improves Some Bleeding Outcomes.

PubMed

Timpa, Joseph G; O'Meara, L Carlisle; Goldberg, Kellen G; Phillips, Jay P; Crawford, Jack H; Jackson, Kimberly W; Alten, Jeffrey A

2016-03-01

Perioperative transfusion of blood products is associated with increased morbidity and mortality after pediatric cardiac surgery. We report the results of a quality improvement project aimed at decreasing perioperative blood product administration and bleeding after pediatric cardiopulmonary bypass (CPB) surgery. A multidisciplinary team evaluated baseline data from 99 consecutive CPB patients, focusing on the variability in transfusion management and bleeding outcomes, to create a standardized bleeding and transfusion management protocol. A total of 62 subsequent patients were evaluated after implementation of the protocol: 17 with single pass hemoconcentrated (SPHC) blood transfusion and 45 with modified ultrafiltration (MUF). Implementation of the protocol with SPHC blood led to significant decrease in transfusion of every blood product in the cardiovascular operating room and first 6 hours in cardiovascular intensive care unit ([CVICU] p < .05). Addition of MUF to the protocol led to further decrease in transfusion of all blood products compared to preprotocol. Patients <2 months old had 49% decrease in total blood product administration: 155 mL/kg preprotocol, 117 mL/kg protocol plus SPHC, and 79 mL/kg protocol plus MUF (p < .01). There were significant decreases in postoperative bleeding in the first hour after CVICU admission: 6 mL/kg preprotocol, 3.8 mL/kg protocol plus SPHC, and 2 mL/kg protocol plusMUF (p = .02). There was also significantly decreased incidence of severe postoperative bleeding (>10 mL/kg) in the first CVICU hour for protocol plus MUF patients (p < .01). Implementation of a multidisciplinary bleeding and transfusion protocol significantly decreases perioperative blood product transfusion and improves some bleeding outcomes.

Medically significant late bleeding after treated crotaline envenomation: a systematic review.

PubMed

Lavonas, Eric J; Khatri, Vaishali; Daugherty, Claire; Bucher-Bartelson, Becki; King, Thomas; Dart, Richard C

2014-01-01

We estimate the proportion of patients with crotaline snake envenomation who are treated with Crotalidae polyvalent immune Fab (ovine) antivenom and who develop medically significant late bleeding. We performed a systematic review of all published cohort studies of North American crotaline snake envenomation patients treated with Fab antivenom. We searched PubMed, Ovid MEDLINE, and EMBASE from January 1, 1997, to April 30, 2012. Data were extracted by 2 trained researchers. Late bleeding was defined as bleeding that began or recurred after initial control of the envenomation syndrome. Medically significant late bleeding was defined a priori as late bleeding treated with RBC transfusion, vasoactive drug infusion, surgery, or rehospitalization or associated with a hemoglobin decrease of greater than or equal to 3 g/dL, hematocrit decrease of greater than or equal to 8%, disability, or death. Summary incidence and 95% confidence intervals (CIs) were calculated with a random-effects Poisson regression model. Nineteen unique cohort studies were identified. Four studies collected data prospectively, and in 9 studies, patients were followed actively after hospital discharge. A total of 1,017 subjects were enrolled in these cohort studies. Late bleeding was reported in 9 subjects (0.9%; 95% CI 0.4% to 2.2%), of whom 5 subjects (0.5%; 95% CI 0.1% to 1.7%) had medically significant late bleeding. Three patients received RBC transfusion; no deaths or permanent sequelae were reported. Estimates of risk may be affected by underreporting. Medically significant late bleeding appears to be uncommon in snakebite victims treated with Fab antivenom. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Prospective analysis of delayed colorectal post-polypectomy bleeding.

PubMed

Park, Soo-Kyung; Seo, Jeong Yeon; Lee, Min-Gu; Yang, Hyo-Joon; Jung, Yoon Suk; Choi, Kyu Yong; Kim, Hungdai; Kim, Hyung Ook; Jung, Kyung Uk; Chun, Ho-Kyung; Park, Dong Il

2018-01-17

Although post-polypectomy bleeding is the most frequent complication after colonoscopic polypectomy, only few studies have investigated the incidence of bleeding prospectively. The aim of this study was to investigate the incidence of delayed post-polypectomy bleeding and its associated risk factors prospectively. Patients who underwent colonoscopic polypectomy at Kangbuk Samsung Hospital from January 2013 to December 2014 were prospectively enrolled in this study. Trained nurses contacted patients via telephone 7 and 30 days after polypectomy and completed a standardized questionnaire regarding the development of bleeding. Delayed post-polypectomy bleeding was categorized as minor or major and early or late bleeding. Major delayed bleeding was defined as a > 2-g/dL drop in the hemoglobin level, requiring hospitalization for control of bleeding or blood transfusion; late delayed bleeding was defined as bleeding occurring later than 24 h after polypectomy. A total of 8175 colonoscopic polypectomies were performed in 3887 patients. Overall, 133 (3.4%) patients developed delayed post-polypectomy bleeding. Among them, 90 (2.3%) and 43 (1.1%) patients developed minor and major delayed bleeding, respectively, and 39 (1.0%) patients developed late delayed bleeding. In the polyp-based multivariate analysis, young age (< 50 years; odds ratio [OR] 2.10; 95% confidence interval [CI] 1.18-3.68), aspirin use (OR 2.78; 95% CI 1.23-6.31), and polyp size of > 10 mm (OR 2.45; 95% CI 1.38-4.36) were significant risk factors for major delayed bleeding, while young age (< 50 years; OR 2.6; 95% CI 1.35-5.12) and immediate bleeding (OR 3.3; 95% CI 1.49-7.30) were significant risk factors for late delayed bleeding. Young age, aspirin use, polyp size, and immediate bleeding were found to be independent risk factors for delayed post-polypectomy bleeding.

[Effect of periodontal therapy on the subgingival microbiota in preeclamptic patients].

PubMed

Jaramillo, Adriana; Arce, Roger; Contreras, Adolfo; Herrera, Julián A

2012-06-01

Few studies have described subgingival microbiota in pregnant women with mild preeclampsia. Clinical periodontal and subgingival microbiota changes were identified in pregnant women with mild preeclampsia after periodontal treatment. In a secondary analysis of a randomized clinical trial, 57 preeclamptic women were studied at Hospital Universitario del Valle in Cali, Colombia. Thirty one women were randomized to the periodontal intervention group (subgingival scaling and planing ultrasonic and manual) during pregnancy and 26 to the control group (supragingival prophylaxis). Periodontal clinical parameters and subgingival microbiota were characterized at the time of acceptance into the study and again at postpartum. Eight periodontopathic bacteria and 2 herpesviruses were assessed by polymerase chain reaction. Chi-square, McNemar or Student's t tests were used, with a significance level of p≤0.05. Both groups were comparable in the clinical and microbiological variables at baseline. Periodontal treatment reduced the average pocket depth in the intervention group from 2.4±0.3 to 2.3±0.2 mm (p<0.001) and in control group 2.6±0.4 to 2.44±0.4 mm, (p<0.001) and bleeding index 16.4±1.5% to 7.9±0.7% in the intervention group(p<0.001) and 17.1±1.8% to 10±0.9% in the control group (p=0.002). The frequency of detection of microorganisms did not differ significantly between groups. Scaling/root planning and supragingival prophylaxis significantly reduced the probing depth and gingival bleeding index. Periodontal treatment was not more effective than prophylaxis in reducing periodontopathic organisms or herpesvirus.

Factors affecting bleeding risk during anticoagulant therapy in patients with atrial fibrillation: observations from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study.

PubMed

DiMarco, John P; Flaker, Gregory; Waldo, Albert L; Corley, Scott D; Greene, H Leon; Safford, Robert E; Rosenfeld, Lynda E; Mitrani, Gladys; Nemeth, Margit

2005-04-01

Stroke and systemic thromboembolism are serious problems for patients with atrial fibrillation (AF), but their incidence can be substantially reduced by appropriate anticoagulation. Bleeding is the major complication of anticoagulant treatment, and the relative risks for bleeding vs stroke must be considered when starting anticoagulation. The AFFIRM trial included patients with AF and at least one risk factor for stroke, randomly assigning them to either a rate-control or rhythm-control strategy. All patients were initially treated with warfarin. The incidence of protocol-defined major and minor bleeding was documented during follow-up. Variables associated with bleeding were determined using a Cox proportional hazards model, using baseline and time-dependent covariates. The 4060 patients in the AFFIRM trial were followed for an average of 3.5 years. Major bleeding occurred in 260 patients, an annual incidence of approximately 2% per year, with no significant difference between the rate-control and rhythm-control groups. Increased age, heart failure, hepatic or renal disease, diabetes, first AF episode, warfarin use, and aspirin use were significantly associated with major bleeding. Minor bleeding was common in both treatment arms, with 738 patients reporting this problem in one or more visits. Bleeding is a significant problem that complicates management of patients with AF. Risk factors for bleeding can be identified, and knowledge of these risk factors can be used to plan therapy.

Salivary calcium concentration and periodontal health of young adults in relation to tobacco smoking.

PubMed

Sutej, Ivana; Peros, Kristina; Benutic, Anica; Capak, Krunoslav; Basic, Kresimir; Rosin-Grget, Kata

2012-01-01

To evaluate the effect of tobacco smoking and salivary calcium on the periodontal status of young adults. Plaque index, gingival bleeding on probing, supragingival calculus, DMFT index, salivary flow, pH and salivary calcium in unstimulated salivary samples were recorded in smokers and nonsmokers. There were no significant differences between smokers and nonsmokers with respect to salivary flow (P = 0.08) and calcium level (P = 0.09). Significant correlations (P < 0.05) were found between a higher calcium level and higher probing depth (r = 0.60), higher number of teeth with probing depth of more than 4 mm (r = 0.70), greater clinical attachment level (r = 0.49) and lower number of teeth bleeding on probing (r = -0.50). Moderate smoking of tobacco cigarettes in young healthy subjects may not have a significant impact on salivary flow or calcium concentrations in unstimulated saliva, but an association exists between an increased level of salivary calcium and development of periodontal disease.

Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial.

PubMed

Christodoulides, Nicos; Nikolidakis, Dimitris; Chondros, Panagiotis; Becker, Jürgen; Schwarz, Frank; Rössler, Ralf; Sculean, Anton

2008-09-01

Recent preclinical and clinical data have suggested a potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of this study was to evaluate the clinical and microbiologic effects of the adjunctive use of PDT to non-surgical periodontal treatment. Twenty-four subjects with chronic periodontitis were randomly treated with scaling and root planing followed by a single episode of PDT (test) or scaling and root planing alone (control). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), gingival recession, and clinical attachment level (CAL) were measured at baseline and 3 and 6 months after therapy. Primary outcome variables were changes in PD and CAL. Microbiologic evaluation of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia (previously T. forsythensis), Treponema denticola, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, and Capnocytophaga spp. was performed at baseline and 3 and 6 months following therapy by using a commercially available polymerase chain reaction test. At 3 and 6 months after treatment, there were no statistically significant differences between the groups with regard to CAL, PD, FMPS, or microbiologic changes. At 3 and 6 months, a statistically significantly greater improvement in FMBS was found in the test group. The additional application of a single episode of PDT to scaling and root planing failed to result in an additional improvement in terms of PD reduction and CAL gain, but it resulted in a significantly higher reduction in bleeding scores compared to scaling and root planing alone.

Weighing the Anti-Ischemic Benefits and Bleeding Risks from Aspirin Therapy: a Rational Approach.

PubMed

Dugani, Sagar; Ames, Jeffrey M; Manson, JoAnn E; Mora, Samia

2018-02-21

The role of aspirin in secondary cardiovascular prevention is well understood; however, the role in primary prevention is less clear, and requires careful balancing of potential benefits with risks. Here, we summarize the evidence base on the benefits and risks of aspirin therapy, discuss clinical practice guidelines and decision support tools to assist in initiating aspirin therapy, and highlight ongoing trials that may clarify the role of aspirin in cardiovascular disease prevention. In 2016, the USPSTF released guidelines on the use of aspirin for primary prevention. Based on 11 trials (n = 118,445), aspirin significantly reduced all-cause mortality and nonfatal myocardial infarction, and in 7 trials that evaluated aspirin ≤ 100 mg/day, there was significant reduction in nonfatal stroke. The USPSTF recommends individualized use of aspirin based on factors including age, 10-year atherosclerotic cardiovascular disease risk score, and bleeding risk. Several ongoing trials are evaluating the role of aspirin in primary prevention, secondary prevention, and in combination therapy for atrial fibrillation. Evidence-based approaches to aspirin use should consider the anti-ischemic benefits and bleeding risks from aspirin. In this era of precision medicine, tools that provide the personalized benefit to risk assessment, such as the freely available clinical decision support tool (Aspirin-Guide), can be easily incorporated into the electronic health record and facilitate more informed decisions about initiating aspirin therapy for primary prevention. Aspirin has a complex matrix of benefits and risks, and its use in primary prevention requires individualized decision-making. Results from ongoing trials may guide healthcare providers in identifying appropriate candidates for aspirin therapy.

Small bowel lymphangiectasia and angiodysplasia: a positive association; novel clinical marker or shared pathophysiology?

PubMed

Macdonald, Jonathan; Porter, Victoria; Scott, Neil W; McNamara, Deirdre

2010-10-01

Small bowel angiodysplasia accounts for 30 to 40% of cases of obscure gastrointestinal bleeding and is associated with significant morbidity and mortality. Identifying lesions can be difficult. Small bowel capsule endoscopy (SBCE) is a significant advance on earlier diagnostic techniques. The cause of angiodysplasia is unknown and the natural history poorly understood. Many lesions are thought to arise from a degenerative process associated with ageing, local vascular anomalies, and tissue hypoxia. Nonpathologic lymphangiectasias are commonly seen throughout the small bowel and are considered a normal finding. To determine whether there is an association between lymphangiectasias, angiodysplasia, and atherosclerosis related conditions. Relevant information was collected from a dedicated SBCE database. Logistic regression analysis was used to examine associations between angiodysplasia, lymphangiectasia, patient demographics, and comorbidity. In all, 180 patients underwent SBCE during the study period, 46 (25%) had angiodysplasia and 47 (26%) lymphangiectasia. Lymphangiectasia were seen in 24 (52%) of 46 with angiodysplasia, in 16 (19%) of 84 with obscure gastrointestinal bleeding without angiodysplasia and in 7 (14%) of 50 without gastrointestinal bleeding. Logistic regression analysis confirmed a strong positive association between angiodysplasia and lymphangiectasia; odds ratio 4.42, P<0.003. Angiodysplasias were also associated with increasing age; odds ratio 1.1. There was no correlation with any other patient characteristic. Lymphangiectasia are strongly associated with the presence of small intestinal angiodysplasia and may represent a useful clinical marker for this condition. Angiodysplasia are also associated with increasing age. Conditions associated with systemic atherosclerosis did not increase the risk of angiodysplasia.

Comparison of minor bleeding complications using dabigatran or enoxaparin after cemented total hip arthroplasty.

PubMed

Gombár, Csaba; Horvath, Gyöngyi; Gálity, Hristifor; Sisák, Krisztián; Tóth, Kálmán

2014-04-01

Orally administered chemical thromboprophylactic agents for total hip replacement (THR) have become popular in recent years. Certain clinical trials suggest that the efficacy and the risk of major bleeding after administration of direct thrombin inhibitor dabigatran etexilate are equivalent to the clinical trial comparator, subcutaneous low-molecular-weight heparin enoxaparin. Our aim was to compare and evaluate the incidence of minor haemorrhagic and soft-tissue adverse effects of enoxaparin and dabigatran. 122 patients who were treated by elective cemented primary THR were enrolled in our quasi-randomised study. Two groups were formed according to which perioperative thromboprophylactic agent was used: 61 patients in enoxaparin group versus 61 patients in dabigatran group. Thigh volume changes, calculated perioperative blood loss, area of haematoma, wound bleeding, duration of wound discharge and intensity of serous wound discharge on postoperative day 3 and day 7 were recorded. The duration and intensity of serous wound discharge differed significantly between the two groups. Duration of wound discharge after drain removal was 2.2 (±2.7) days in the dabigatran group and 1.2 (±1.9) days in the enoxaparin group (p < 0.05). Significant increase in serous discharge was found in the dabigatran group (p < 0.05) on third and seventh postoperative days compared to the enoxaparin group. Both thromboprophylactic agents were found to have appropriate antithrombotic effects after THR. However, dabigatran was associated with an increased incidence of prolonged serous wound discharge, which might cause longer hospitalization and might instigate the use of prolonged antibiotic prophylaxis.

Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial.

PubMed

Eisen, Alon; Giugliano, Robert P; Ruff, Christian T; Nordio, Francesco; Gogia, Harinder S; Awasty, Vivek R; Henderson, David A; Mercuri, Michele F; Rutman, Howard; Antman, Elliott M; Braunwald, Eugene

2016-02-01

Edoxaban is a specific anti-Xa inhibitor that, in comparison to warfarin, has been found to be noninferior for the prevention of stroke or systemic embolism (SSE) and to reduce bleeding significantly in patients with nonvalvular atrial fibrillation (AF). The US Food and Drug Administration (FDA) approved the higher-dose edoxaban regimen (60/30 mg) in patients with AF and a creatinine clearance of ≤95 mL/min. We report for the first time the clinical characteristics, efficacy, and safety of the FDA-approved population in the ENGAGE AF--TIMI 48 trial. The patients included had been treated with either warfarin or edoxaban 60/30 mg and had a creatinine clearance of ≤95 mL/min. The primary efficacy was SSE, and the principal safety end point was major bleeding (International Society on Thrombosis and Haemostasis classification). Median follow-up was 2.8 years. Patients in the FDA-approved cohort were older, were more likely female, and had higher CHADS2 and HAS-BLED scores, as compared with patients not included in the FDA label. The primary end point occurred in 1.63%/y with edoxaban vs 2.02%/y with warfarin (hazard ratio [HR] 0.81, 95% CI 0.67-0.97, P = .023). Edoxaban significantly reduced the rate of hemorrhagic stroke (HR 0.47, 95% CI 0.31-0.72, P < .001) and cardiovascular death (HR 0.84, 95% CI 0.73-0.97, P = .015). Ischemic stroke rates were similar between the treatment groups (1.31%/y vs 1.39%/y, P = .97). Major bleeding was significantly lower with edoxaban (3.16%/y vs 3.77%/y; HR 0.84, 95% CI 0.72-0.98, P = .023). In the FDA-approved cohort of the ENGAGE AF--TIMI 48 trial, treatment with edoxaban 60/30 mg was superior to warfarin in the prevention of SSE and significantly reduced cardiovascular death and bleeding, especially fatal bleeding and hemorrhagic stroke. Copyright © 2015 Elsevier Inc. All rights reserved.

In vivo imaging of twist drill drainage for subdural hematoma: a clinical feasibility study on electrical impedance tomography for measuring intracranial bleeding in humans.

PubMed

Dai, Meng; Li, Bing; Hu, Shijie; Xu, Canhua; Yang, Bin; Li, Jianbo; Fu, Feng; Fei, Zhou; Dong, Xiuzhen

2013-01-01

Intracranial bleeding is one of the most severe medical emergencies in neurosurgery. Early detection or diagnosis would largely reduce the rate of disability and mortality, and improve the prognosis of the patients. Electrical Impedance Tomography (EIT) can non-invasively image the internal resistivity distribution within a human body using a ring of external electrodes, and is thus a promising technique to promptly detect the occurrence of intracranial bleedings because blood differs from other brain tissues in resistivity. However, so far there is no experimental study that has determined whether the intracranial resistivity changes in humans could be repeatedly detected and imaged by EIT. Hence, we for the first time attempt to clinically validate this by in vivo imaging the influx and efflux of irrigating fluid (5% dextrose in water, D5W) during the twist-drill drainage operation for the patients with subdural hematoma (SDH). In this study, six patients (four male, two female) with subacute or chronic SDH received the surgical operation in order to evacuate the hematoma around subdural region, and EIT measurements were performed simultaneously on each patient's head. The results showed that the resistivity significantly increased on the corresponding position of EIT images during the influx of D5W and gradually decreased back to baseline during the efflux. In the quantitative analysis, the average resistivity values demonstrated the similar results and had highly linear correlation (R(2) = 0.93 ± 0.06) with the injected D5W volumes, as well as the area of the resistivity gain(R(2) = 0.94 ± 0.05). In conclusion, it was clinically validated that intracranial resistivity changes in humans were detectable and quantifiable by the EIT method. After further technical improvements, EIT has the great potential of being a routine neuroimaging tool for early detection of intracranial bleedings.

In Vivo Imaging of Twist Drill Drainage for Subdural Hematoma: A Clinical Feasibility Study on Electrical Impedance Tomography for Measuring Intracranial Bleeding in Humans

PubMed Central

Xu, Canhua; Yang, Bin; Li, Jianbo; Fu, Feng; Fei, Zhou; Dong, Xiuzhen

2013-01-01

Intracranial bleeding is one of the most severe medical emergencies in neurosurgery. Early detection or diagnosis would largely reduce the rate of disability and mortality, and improve the prognosis of the patients. Electrical Impedance Tomography (EIT) can non-invasively image the internal resistivity distribution within a human body using a ring of external electrodes, and is thus a promising technique to promptly detect the occurrence of intracranial bleedings because blood differs from other brain tissues in resistivity. However, so far there is no experimental study that has determined whether the intracranial resistivity changes in humans could be repeatedly detected and imaged by EIT. Hence, we for the first time attempt to clinically validate this by in vivo imaging the influx and efflux of irrigating fluid (5% dextrose in water, D5W) during the twist-drill drainage operation for the patients with subdural hematoma (SDH). In this study, six patients (four male, two female) with subacute or chronic SDH received the surgical operation in order to evacuate the hematoma around subdural region, and EIT measurements were performed simultaneously on each patient’s head. The results showed that the resistivity significantly increased on the corresponding position of EIT images during the influx of D5W and gradually decreased back to baseline during the efflux. In the quantitative analysis, the average resistivity values demonstrated the similar results and had highly linear correlation (R2 = 0.93±0.06) with the injected D5W volumes, as well as the area of the resistivity gain(R2 = 0.94±0.05). In conclusion, it was clinically validated that intracranial resistivity changes in humans were detectable and quantifiable by the EIT method. After further technical improvements, EIT has the great potential of being a routine neuroimaging tool for early detection of intracranial bleedings. PMID:23372808

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com; Nolte, Marc W.; Solomon, Cristina

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii)more » the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated, with no adverse events. • Overall, human fibrinogen concentrate demonstrated a good safety profile. • This data adds to the safety information available to date on this hemostatic agent.« less

Use of concomitant aspirin in patients with atrial fibrillation: Findings from the ROCKET AF trial.

PubMed

Shah, Rohan; Hellkamp, Anne; Lokhnygina, Yuliya; Becker, Richard C; Berkowitz, Scott D; Breithardt, Günter; Hacke, Werner; Halperin, Jonathan L; Hankey, Graeme J; Fox, Keith A A; Nessel, Christopher C; Mahaffey, Kenneth W; Piccini, Jonathan P; Singer, Daniel E; Patel, Manesh R

2016-09-01

We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), in particular, those with known coronary artery disease (CAD). Patients in ROCKET AF, comparing rivaroxaban and warfarin, were analyzed. Aspirin use was assessed at baseline. Stroke and systemic embolism, myocardial infarction, death, and major or nonmajor clinically relevant (NMCR) bleeding were compared between groups. Multivariable modeling was done adjusting for baseline risk factors. A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2mg); 30.6% of those had known CAD. Patients receiving aspirin were more likely to have prior myocardial infarction (22% vs 14%; P<.001) and heart failure (68% vs 59%; P<.001). Relative efficacy of rivaroxaban versus warfarin was similar with and without aspirin use for both stroke/systemic embolism (P=.95 for interaction), and major or NMCR bleeding (P=.76 for interaction). After adjustment, aspirin use was associated with similar rates of stroke/systemic embolism (hazard ratio [HR] 1.16, 95% CI 0.98-1.37; P=.094) but higher rates of all-cause death (HR 1.27, 95% CI 1.13-1.42; P<.0001) and major or NMCR bleeding (HR 1.32, 95% CI 1.21-1.43; P<.0001). There was a significant interaction between no CAD at baseline and aspirin for all-cause death (P=.009). Aspirin use at baseline was associated with an increased risk for bleeding and all-cause death in ROCKET AF, a risk most pronounced in patients without known CAD. Although these findings may reflect unmeasured clinical factors, further investigation is warranted to determine optimal aspirin use in patients with AF. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of postoperative coagulation profiles and outcome for sugammadex versus pyridostigmine in 992 living donors after living-donor hepatectomy

PubMed Central

Moon, Young-Jin; Kim, Sung-Hoon; Kim, Jae-Won; Lee, Yoon-Kyung; Jun, In-Gu; Hwang, Gyu-Sam

2018-01-01

Abstract Donor safety is the major concern in living donor liver transplantation, although hepatic resection may be associated with postoperative coagulopathy. Recently, the use of sugammadex has been gradually increased, but sugammadex is known to prolong prothrombin time (PT) and activated partial thromboplastin time (aPTT). We compared the postoperative coagulation profiles and outcomes of sugammadex versus pyridostigmine group in donors receiving living donor hepatectomy. Consecutive donor hepatectomy performed between September 2013 and August 2016 was retrospectively analyzed. For reversal of rocuronium-induced neuromuscular blockade, donors received sugammadex 4 mg/kg or pyridostigmine 0.25 mg/kg. The primary end-points were laboratory findings (PT, aPTT, hemoglobin, platelet count) and clinically evaluated postoperative bleeding (relaparotomy for bleeding, cumulative volume collected in drains). Secondary outcomes were anesthesia time, postoperative hospital day. Of 992 donors, 383 treated with sugammadex and 609 treated with pyridostigmine for the reversal of neuromuscular blockade. There were no significant differences between both groups for drop in hemoglobin and platelet, prolongation in PT, aPTT, and the amount of 24-h drain volume. Bleeding events within 24 h were reported in 2 (0.3%) for pyridostigmine group and 0 (0%) for sugammadex group (P = .262). Anesthesia time was significantly longer in pyridostigmine group than that in sugammadex group (438.8 ± 71.4 vs. 421.3 ± 62.3, P < .001). Postoperative hospital stay was significantly longer in pyridostigmine group than that in sugammadex group (P = .002). Sugammadex 4 mg/kg was not associated with increased bleeding tendency, but associated with reduced anesthesia time and hospital stay. Therefore, sugammadex may be safely used and will decrease morbidity in donor undergoing living-donor hepatectomy. PMID:29538210

Comparison of postoperative coagulation profiles and outcome for sugammadex versus pyridostigmine in 992 living donors after living-donor hepatectomy.

PubMed

Moon, Young-Jin; Kim, Sung-Hoon; Kim, Jae-Won; Lee, Yoon-Kyung; Jun, In-Gu; Hwang, Gyu-Sam

2018-03-01

Donor safety is the major concern in living donor liver transplantation, although hepatic resection may be associated with postoperative coagulopathy. Recently, the use of sugammadex has been gradually increased, but sugammadex is known to prolong prothrombin time (PT) and activated partial thromboplastin time (aPTT). We compared the postoperative coagulation profiles and outcomes of sugammadex versus pyridostigmine group in donors receiving living donor hepatectomy.Consecutive donor hepatectomy performed between September 2013 and August 2016 was retrospectively analyzed. For reversal of rocuronium-induced neuromuscular blockade, donors received sugammadex 4 mg/kg or pyridostigmine 0.25 mg/kg. The primary end-points were laboratory findings (PT, aPTT, hemoglobin, platelet count) and clinically evaluated postoperative bleeding (relaparotomy for bleeding, cumulative volume collected in drains). Secondary outcomes were anesthesia time, postoperative hospital day.Of 992 donors, 383 treated with sugammadex and 609 treated with pyridostigmine for the reversal of neuromuscular blockade. There were no significant differences between both groups for drop in hemoglobin and platelet, prolongation in PT, aPTT, and the amount of 24-h drain volume. Bleeding events within 24 h were reported in 2 (0.3%) for pyridostigmine group and 0 (0%) for sugammadex group (P = .262). Anesthesia time was significantly longer in pyridostigmine group than that in sugammadex group (438.8 ± 71.4 vs. 421.3 ± 62.3, P < .001). Postoperative hospital stay was significantly longer in pyridostigmine group than that in sugammadex group (P = .002).Sugammadex 4 mg/kg was not associated with increased bleeding tendency, but associated with reduced anesthesia time and hospital stay. Therefore, sugammadex may be safely used and will decrease morbidity in donor undergoing living-donor hepatectomy.

Variceal bleeding and portal hypertension: new lights on old horizon.

PubMed

Bhasin, D K; Siyad, I

2004-02-01

New clinical, endoscopic, and imaging modalities for diagnosing varices and predicting bleeding are being investigated. Transnasal endoscopy and ultrathin battery-powered esophagoscopes are being used to improve patient comfort and compliance. Patients who respond to portal pressure-reducing drugs not only have a reduced risk of bleeding, but also a reduced risk of developing other complications, with improved survival. Nitrates have been shown to have no definite role in primary prophylaxis against variceal bleeding. The hemodynamic response to treatment has an independent prognostic value for the risk of variceal bleeding. Newer drugs have been investigated for reducing the hepatic venous pressure gradient, but with little success. Survival after bleeding has increased due to improved patient care and technological advances. Combined radiographic and endoscopic management of gastric varices is evolving and appears to be promising. Nonvariceal bleeding from portal hypertensive gastropathy is increasingly being recognized as a potential cause of bleeding in patients with portal hypertension, and pharmacotherapy with octreotide appears to be promising for the treatment of this condition. Variceal band ligation in children has been found to be as safe and effective as in adults.

Variable Resistance to Plasminogen Activator Initiated Fibrinolysis for Intermediate-Risk Pulmonary Embolism.

PubMed

Stubblefield, William B; Alves, Nathan J; Rondina, Matthew T; Kline, Jeffrey A

2016-01-01

We examine the clinical significance and biomarkers of tissue plasminogen activator (tPA)-catalyzed clot lysis time (CLT) in patients with intermediate-risk pulmonary embolism (PE). Platelet-poor, citrated plasma was obtained from patients with PE. Healthy age- and sex-matched patients served as disease-negative controls. Fibrinogen, α2-antiplasmin, plasminogen, thrombin activatable fibrinolysis inhibitor (TAFI), plasminogen activator Inhibitor 1 (PAI-1), thrombin time and D-dimer were quantified. Clotting was induced using CaCl2, tissue factor, and phospholipid. Lysis was induced using 60 ng/mL tPA. Time to 50% clot lysis (CLT) was assessed by both thromboelastography (TEG) and turbidimetry (A405). Compared with disease-negative controls, patients with PE exhibited significantly longer mean CLT on TEG (+2,580 seconds, 95% CI 1,380 to 3,720 sec). Patients with PE and a short CLT who were treated with tenecteplase had increased risk of bleeding, whereas those with long CLT had significantly worse exercise tolerance and psychometric testing for quality of life at 3 months. A multivariate stepwise removal regression model selected PAI-1 and TAFI as predictive biomarkers of CLT. The CLT from TEG predicted increased risk of bleeding and clinical failure with tenecteplase treatment for intermediate-risk PE. Plasmatic PAI-1 and TAFI were independent predictors of CLT.

Clinical update on thrombolytic use in pulmonary embolism: A focus on intermediate-risk patients.

PubMed

Eberle, Hannah; Lyn, Raquel; Knight, Tamara; Hodge, Emily; Daley, Mitchell

2018-06-12

Current literature on clinical controversies surrounding the use of thrombolytic agents in patients with intermediate-risk pulmonary embolism (PE) is reviewed. PE is a major cause of morbidity and mortality. When used in conjunction with anticoagulation, thrombolysis has been shown to reduce hemodynamic decompensation in select patients, but thrombolytic therapy is associated with high risks of bleeding and intracranial hemorrhage and its role in treating patients with intermediate-risk PE remains controversial. In the PEITHO study, the largest trial to date involving only patients with intermediate-risk PE ( n = 1,006), patients receiving the thrombolytic agent tenecteplase were significantly ( p = 0.02) less likely than those receiving unfractionated heparin to develop the primary outcome, a composite of death from any cause and hemodynamic decompensation or collapse within 7 days. However, a meta-analysis of data from clinical trials of systemic thrombolytic therapy in intermediate-risk PE generally showed a lack of benefit in terms of all-cause mortality and long-term complications. Novel strategies for treatment of intermediate-risk PE, including low-dose thrombolysis and catheter-directed thrombolysis, are being investigated in an attempt to identify strategies that provide therapeutic outcomes equivalent to those provided by traditional thrombolytic modalities but with a decreased risk of bleeding. The use of thrombolysis in the treatment of intermediate-risk PE is complicated by high rates of bleeding and should be limited to patients who clinically deteriorate rather than given as a standard-of-care treatment in this population. Data for low-dose thrombolysis remain limited. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Different doses of prophylactic platelet transfusion for preventing bleeding in people with haematological disorders after myelosuppressive chemotherapy or stem cell transplantation

PubMed Central

Estcourt, Lise J; Stanworth, Simon; Doree, Carolyn; Trivella, Marialena; Hopewell, Sally; Blanco, Patricia; Murphy, Michael F

2015-01-01

Background Platelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding. This is an update of a Cochrane review first published in 2004, and updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews; this review compares different platelet transfusion doses. Objectives To determine whether different doses of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect their efficacy and safety in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy with or without haematopoietic stem cell transplantation (HSCT). Search methods We searched for randomised controlled trials in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015. Selection criteria Randomised controlled trials involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with malignant haematological disorders or undergoing HSCT that compared different platelet component doses (low dose 1.1 × 1011/m2 ± 25%, standard dose 2.2 × 1011/m2 ± 25%, high dose 4.4 × 1011/m2 ± 25%). Data collection and analysis We used the standard methodological procedures expected by The Cochrane Collaboration. Main results We included seven trials (1814 participants) in this review; six were conducted during one course of treatment (chemotherapy or HSCT). Overall the methodological quality of studies was low to moderate across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity. Five studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no difference in the number of participants with a clinically significant bleeding episode between the low-dose and standard-dose groups (four studies; 1170 participants; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.13; moderate-quality evidence); low-dose and high-dose groups (one study; 849 participants; RR 1.02, 95% CI 0.93 to 1.11; moderate-quality evidence); or high-dose and standard-dose groups (two studies; 951 participants; RR 1.02, 95% CI 0.93 to 1.11; moderate-quality evidence). Three studies reported the number of days with a clinically significant bleeding event per participant. There was no difference in the number of days of bleeding per participant between the low-dose and standard-dose groups (two studies; 230 participants; mean difference −0.17, 95% CI −0.51 to 0.17; low quality evidence). One study (855 participants) showed no difference in the number of days of bleeding per participant between high-dose and standard-dose groups, or between low-dose and high-dose groups (849 participants). Three studies reported the number of participants with severe or life-threatening bleeding. There was no difference in the number of participants with severe or life-threatening bleeding between a low-dose and a standard-dose platelet transfusion policy (three studies; 1059 participants; RR 1.33, 95% CI 0.91 to 1.92; low-quality evidence); low-dose and high-dose groups (one study; 849 participants; RR 1.20, 95% CI 0.82 to 1.77; low-quality evidence); or high-dose and standard-dose groups (one study; 855 participants; RR 1.11, 95% CI 0.73 to 1.68; low-quality evidence). Two studies reported the time to first bleeding episodes; we were unable to perform a meta-analysis. Both studies (959 participants) individually found that the time to first bleeding episode was either the same, or longer, in the low-dose group compared to the standard-dose group. One study (855 participants) found that the time to the first bleeding episode was the same in the high-dose group compared to the standard-dose group. Three studies reported all-cause mortality within 30 days from the start of the study. There was no difference in all-cause mortality between treatment arms (low-dose versus standard-dose: three studies; 1070 participants; RR 2.04, 95% CI 0.70 to 5.93; low-quality evidence; low-dose versus high-dose: one study; 849 participants; RR 1.33, 95% CI 0.50 to 3.54; low-quality evidence; and high-dose versus standard-dose: one study; 855 participants; RR 1.71, 95% CI 0.51 to 5.81; low-quality evidence). Six studies reported the number of platelet transfusions; we were unable to perform a meta-analysis. Two studies (959 participants) out of three (1070 participants) found that a low-dose transfusion strategy led to more transfusion episodes than a standard-dose. One study (849 participants) found that a low-dose transfusion strategy led to more transfusion episodes than a high-dose strategy. One study (855 participants) out of three (1007 participants) found no difference in the number of platelet transfusions between the high-dose and standard-dose groups. One study reported on transfusion reactions. This study’s authors suggested that a high-dose platelet transfusion strategy may lead to a higher rate of transfusion-related adverse events. None of the studies reported quality-of-life. Authors’ conclusions In haematology patients who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found no evidence to suggest that a low-dose platelet transfusion policy is associated with an increased bleeding risk compared to a standard-dose or high-dose policy, or that a high-dose platelet transfusion policy is associated with a decreased risk of bleeding when compared to a standard-dose policy. A low-dose platelet transfusion strategy leads to an increased number of transfusion episodes compared to a standard-dose strategy. A high-dose platelet transfusion strategy does not decrease the number of transfusion episodes per participant compared to a standard-dose regimen, and it may increase the number of transfusion-related adverse events. Findings from this review would suggest a change from current practice, with low-dose platelet transfusions used for people receiving in-patient treatment for their haematological disorder and high-dose platelet transfusion strategies not being used routinely. PMID:26505729

Evaluation of clinical outcomes among nonvalvular atrial fibrillation patients treated with rivaroxaban or warfarin, stratified by renal function
.

PubMed

Weir, Matthew R; Haskell, Lloyd; Berger, Jeffrey S; Ashton, Veronica; Laliberté, François; Crivera, Concetta; Brown, Kip; Lefebvre, Patrick; Schein, Jeffrey

2018-05-01

Renal dysfunction increases the risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF). Adult NVAF patients with ≥ 6 months prior to first warfarin or rivaroxaban dispensing were selected from the IMS Health Real-World Data Adjudicated Claims database (05/2011 - 06/2015) with electronic medical records. Ischemic stroke events, thromboembolic events (venous thromboembolism, myocardial infarction, or ischemic stroke), and major bleeding events were compared between patients by renal function identified by 1) relevant ICD-9-CM diagnosis codes and 2) estimated creatinine clearance (eCrCl). Baseline confounders were adjusted using inverse probability of treatment weights. The diagnosis-based analysis included 39,872 rivaroxaban and 48,637 warfarin users (3,572 and 8,230 with renal dysfunction, respectively). The eCrCl-based analysis included 874 rivaroxaban and 1,069 warfarin users (66 and 208 with eCrCl < 60 mL/min, respectively). In the diagnosis-based analysis, rivaroxaban users with renal dysfunction had a significantly lower stroke rate (HR = 0.55, p = 0.0004) compared to warfarin users; rivaroxaban users with and without renal dysfunction had significantly lower thromboembolic event rates (HR = 0.62, p < 0.0001; and HR = 0.64, p < 0.0001, respectively), and similar major bleeding rates to warfarin users. In the eCrCl-based analysis, rivaroxaban users with eCrCl ≥ 60 mL/min had a significantly lower thromboembolic event rate, but other outcomes were not statistically significant. Rivaroxaban-treated NVAF patients with diagnosed renal dysfunction had a significantly lower stroke rate compared to warfarin-treated patients. Regardless of renal dysfunction diagnoses, rivaroxaban users had lower thromboembolic event rates compared to warfarin users, and a similar rate of major bleeding. eCrCl-based analysis was limited by a small sample size.
.

Minimizing bleeding complications in spinal tumor surgery with preoperative Onyx embolization via dual-lumen balloon catheter.

PubMed

Ladner, Travis R; He, Lucy; Lakomkin, Nikita; Davis, Brandon J; Cheng, Joseph S; Devin, Clinton J; Mocco, J

2016-02-01

Intraoperative bleeding is a significant risk in surgery for highly vascular spinal tumors, but preoperative embolization can safely decrease intraoperative blood loss in extrinsic spine tumors. Onyx, widely used for cerebrovascular embolization, has been increasingly used as an embolic agent for preoperative spinal tumor embolization. The Scepter catheter, a dual-lumen balloon catheter, may improve tumor parenchymal penetration without the danger and limitations of significant embolic reflux. This may reduce bleeding risk during spinal surgery. Eleven consecutive cases of preoperative Onyx embolization of extrinsic spinal tumors were identified, all of whom had subsequent spinal surgery. Demographic data and clinical variables were collected. Patients were divided into Scepter (n=6) and non-Scepter (n=5) groups. The Mann-Whitney U test was used to compare continuous outcome variables and the Fisher exact test was used to compare categorical variables. Estimated blood loss in the Scepter group was significantly lower than in the non-Scepter group (584±124 vs 2400±738 mL, p=0.004). The volume of intraoperative transfusion was also significantly lower (1.2±0.4 vs 5.8±1.7 units, p=0.004). There was no significant difference in the number of vessels embolized, vials of Onyx used, use of coiling adjunct, contrast load, radiation dose, or fluoroscopy time per pedicle (p>0.05). The addition of the Scepter catheter to preoperative Onyx embolization is safe and feasible. In this small series, the Scepter catheter was associated with a reduction of intraoperative bleeding by 76% and a 79% lower transfusion volume. This was not accompanied by any unwanted increase in vials of Onyx used, contrast load, radiation dose, or fluoroscopy time. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases

PubMed Central

Richter-Schrag, Hans-Jürgen; Glatz, Torben; Walker, Christine; Fischer, Andreas; Thimme, Robert

2016-01-01

AIM To evaluate rebleeding, primary failure (PF) and mortality of patients in whom over-the-scope clips (OTSCs) were used as first-line and second-line endoscopic treatment (FLET, SLET) of upper and lower gastrointestinal bleeding (UGIB, LGIB). METHODS A retrospective analysis of a prospectively collected database identified all patients with UGIB and LGIB in a tertiary endoscopic referral center of the University of Freiburg, Germany, from 04-2012 to 05-2016 (n = 93) who underwent FLET and SLET with OTSCs. The complete Rockall risk scores were calculated from patients with UGIB. The scores were categorized as < or ≥ 7 and were compared with the original Rockall data. Differences between FLET and SLET were calculated. Univariate and multivariate analysis were performed to evaluate the factors that influenced rebleeding after OTSC placement. RESULTS Primary hemostasis and clinical success of bleeding lesions (without rebleeding) was achieved in 88/100 (88%) and 78/100 (78%), respectively. PF was significantly lower when OTSCs were applied as FLET compared to SLET (4.9% vs 23%, P = 0.008). In multivariate analysis, patients who had OTSC placement as SLET had a significantly higher rebleeding risk compared to those who had FLET (OR 5.3; P = 0.008). Patients with Rockall risk scores ≥ 7 had a significantly higher in-hospital mortality compared to those with scores < 7 (35% vs 10%, P = 0.034). No significant differences were observed in patients with scores < or ≥ 7 in rebleeding and rebleeding-associated mortality. CONCLUSION Our data show for the first time that FLET with OTSC might be the best predictor to successfully prevent rebleeding of gastrointestinal bleeding compared to SLET. The type of treatment determines the success of primary hemostasis or primary failure. PMID:27895403

Association between diabetes-related factors and clinical periodontal parameters in type-2 diabetes mellitus.

PubMed

Kim, Eun-Kyong; Lee, Sang Gyu; Choi, Youn-Hee; Won, Kyu-Chang; Moon, Jun Sung; Merchant, Anwar T; Lee, Hee-Kyung

2013-11-07

Evidence consistently shows that diabetes is a risk factor for increased prevalence of gingivitis and periodontitis. But there is a controversy about the relationship between diabetes related factors and periodontal health. The aim of the present study is to explore the relationship between diabetes related factors such as glycosylated hemoglobin, fasting blood glucose, duration of diabetes and compliance to diabetes self management and periodontal health status. Periodontal health of 125 participants with type-2 diabetes mellitus was measured by the number of missing teeth, community periodontal index (CPI), Russell's periodontal index and papillary bleeding index. Information on sociodemographic factors, oral hygiene behavior, duration and compliance to self management of diabetes, levels of glycosylated hemoglobin(HbA1c) and fasting blood glucose(FBG) were collected by interview and hospital medical records. Statistically, independent t-test, an analysis of variance (ANOVA), chi-squared test and multiple regression analyses were used to assess the association between diabetes-related factors and periodontal health. Periodontal parameters including the number of missing teeth and papillary bleeding index were significantly influenced by duration of diabetes, FBG and compliance to self management of diabetes. CPI was significantly influenced by duration of diabetes, FBG and HbA1C. And Russell's periodontal index was significantly influenced by duration of diabetes, FBG, HbA1C and compliance to self management of diabetes. Results of multiple linear regression analysis showed that the duration of diabetes showed significant positive correlation with all of the periodontal health parameters, except for missing teeth. HbA1c was correlated with Russell's periodontal and papillary bleeding index. FBG and compliance to self management of diabetes were correlated with missing teeth and papillary bleeding index respectively. Diabetes-related factors such as duration of diabetes, FBG, HbA1c and compliance to self management of diabetes were significantly correlated with periodontal health among individuals with type-2 diabetes.

Long-term prophylaxis in severe factor VII deficiency.

PubMed

Siboni, S M; Biguzzi, E; Mistretta, C; Garagiola, I; Peyvandi, F

2015-11-01

The spectrum of bleeding problems in FVII deficiency is highly variable and FVII levels and causative genetic mutations correlate poorly with the bleeding risk. Long-term prophylaxis is generally initiated in order to prevent subsequent CNS bleeding after a first event or in patients with other major/ life threatening/ frequent bleeding symptoms as gastrointestinal bleeding or hemarthrosis. However few data are available in the literature regarding FVII prophylaxis and clinical decisions cannot be based on evidence. We report the data available in the literature on FVII prophylaxis and our personal experience regarding three patients affected by severe FVII deficiency. Specific papers on long-term prophylaxis in severe FVII deficiency were identified using the database, PUBMED. The most frequent indications for long-term prophylaxis were CNS bleeding (58%), hemartrosis (15%) and GI bleeding (9%). Patients were treated with various dosages and frequency. Prophylactic treatment with 10-30U/kg (pdFVII) or 20-30mcg/kg (rFVIIa) twice or three times/weeks was described to be effective. In the literature and in our experience, prophylaxis can be considered in patients with severe FVII deficiency and severe bleeding phenotype. A dose of 10-30U/kg (pdFVII) or 20-30 microg/kg (rFVIIa) twice or three times/week is usually administrated, but dose and frequency can be tailored based on the clinical follow-up of the patients. Since hemarthrosis is a frequent manifestation, a suggestion to improve the outcomes of patients with severe FVII deficiency is to monitor joint condition in order to identify early arthropathy that could be another indication to start secondary prophylaxis. © 2015 John Wiley & Sons Ltd.

Women with congenital factor VII deficiency: clinical phenotype and treatment options from two international studies.

PubMed

Napolitano, M; Di Minno, M N D; Batorova, A; Dolce, A; Giansily-Blaizot, M; Ingerslev, J; Schved, J-F; Auerswald, G; Kenet, G; Karimi, M; Shamsi, T; Ruiz de Sáez, A; Dolatkhah, R; Chuansumrit, A; Bertrand, M A; Mariani, G

2016-09-01

A paucity of data exists on the incidence, diagnosis and treatment of bleeding in women with inherited factor VII (FVII) deficiency. Here we report results of a comprehensive analysis from two international registries of patients with inherited FVII deficiency, depicting the clinical picture of this disorder in women and describing any gender-related differences. A comprehensive analysis of two fully compatible, international registries of patients with inherited FVII deficiency (International Registry of Factor VII deficiency, IRF7; Seven Treatment Evaluation Registry, STER) was performed. In our cohort (N = 449; 215 male, 234 female), the higher prevalence of mucocutaneous bleeds in females strongly predicted ensuing gynaecological bleeding (hazard ratio = 12.8, 95% CI 1.68-97.6, P = 0.014). Menorrhagia was the most prevalent type of bleeding (46.4% of patients), and was the presentation symptom in 12% of cases. Replacement therapies administered were also analysed. For surgical procedures (n = 50), a receiver operator characteristic analysis showed that the minimal first dose of rFVIIa to avoid postsurgical bleeding during the first 24 hours was 22 μg kg(-1) , and no less than two administrations. Prophylaxis was reported in 25 women with excellent or effective outcomes when performed with a total weekly rFVIIa dose of 90 μg kg(-1) (divided as three doses). Women with FVII deficiency have a bleeding disorder mainly characterized by mucocutaneous bleeds, which predicts an increased risk of ensuing gynaecological bleeding. Systematic replacement therapy or long-term prophylaxis with rFVIIa may reduce the impact of menorrhagia on the reproductive system, iron loss and may avoid unnecessary hysterectomies. © 2016 John Wiley & Sons Ltd.

Clinical and Economic Impact of a Multisciplinary Intervention to Reduce Bleeding Risk in Patients With Acute Coronary Syndrome.

PubMed

de Lorenzo-Pinto, Ana; Herranz-Alonso, Ana; Cuéllar-Basterrechea, Begoña; Bellón-Cano, José María; Sanjurjo-Sáez, María; Bueno, Héctor

2017-10-01

To evaluate the clinical and economic impact of a multidisciplinary program to reduce bleeding events in patients with acute coronary syndrome through optimization of antithrombotic therapy. We designed a preintervention (PRE) and postintervention (POST) quasi-experimental study using a retrospective analysis of 2 cohorts. The first cohort was analyzed to detect correctable measures contributing to bleeding (PRE). Afterward, a quality improvement intervention with a bundle of recommendations was implemented. Finally, a second cohort of patients was evaluated to investigate the impact of the measures on bleeding reduction (POST). The impact on health outcomes was evaluated through comparison of the percentage of in-hospital bleeding events and 30-day readmissions between the 2 cohorts. The economic analysis took into account the costs associated with the implementation of the program and the cost-savings associated with the prevention of bleeding events and 30-day readmissions. A total of 677 patients were included (377 in PRE and 300 in POST). The total bleeding rate was reduced after the implementation of the bundled intervention by 29.2% (31.6% in POST vs 22.3% in PRE; OR, 0.62; 95%CI, 0.44-0.88) while 30-day readmission rates were 7.7% in PRE and 5% in POST (P=.20). The estimated avoided cost was €95 113.6 per year, meaning that €10.1 would be obtained in return for each euro invested during the first year and €36.3 during the following years. This multidisciplinary program has proven to be effective in reducing bleeding events and is economically attractive. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Net clinical benefit of rivaroxaban compared with warfarin in atrial fibrillation: Results from ROCKET AF.

PubMed

Barnett, Adam S; Cyr, Derek D; Goodman, Shaun G; Levitan, Bennett S; Yuan, Zhong; Hankey, Graeme J; Singer, Daniel E; Becker, Richard C; Breithardt, Günter; Berkowitz, Scott D; Halperin, Jonathan L; Hacke, Werner; Mahaffey, Kenneth W; Nessel, Christopher C; Fox, Keith A A; Patel, Manesh R; Piccini, Jonathan P

2018-04-15

The aim of this study was to determine the net clinical benefit (NCB) of rivaroxaban compared with warfarin in patients with atrial fibrillation. This was a retrospective analysis of 14,236 patients included in ROCKET AF who received at least one dose of study drug. We analyzed NCB using four different methods: (1) composite of death, stroke, systemic embolism, myocardial infarction, and major bleeding; (2) method 1 with fatal or critical organ bleeding substituted for major bleeding; (3) difference between the rate of ischemic stroke or systemic embolism minus 1.5 times the difference between the rate of intracranial hemorrhage; and (4) weighted sum of differences between rates of death, ischemic stroke or systemic embolism, intracranial hemorrhage, and major bleeding. Rivaroxaban was associated with a lower risk of the composite outcome of death, myocardial infarction, stroke, or systemic embolism (rate difference per 10,000 patient-years [RD]=-86.8 [95% CI -143.6 to -30.0]) and fatal or critical organ bleeding (-41.3 [-68 to -14.7]). However, rivaroxaban was associated with a higher risk of major bleeding other than fatal or critical organ bleeding (55.9 [14.7 to 97.2]). Method 1 showed no difference between treatments (-35.5 [-108.4 to 37.3]). Methods 2-4 favored treatment with rivaroxaban (2: -96.8 [-157.0 to -36.8]; 3: -65.2 [-112.3 to -17.8]; 4: -54.8 [-96.0 to -10.2]). Rivaroxaban was associated with favorable NCB compared with warfarin. The NCB was attributable to lower rates of ischemic events and fatal or critical organ bleeding. Copyright © 2017 Elsevier B.V. All rights reserved.

A rare case of bleeding disorder: Glanzmann's thrombasthenia.

PubMed

Swathi, Jami; Gowrishankar, A; Jayakumar, S A; Jain, Karun

2017-01-01

Glanzmann's thrombasthenia (GT) is a rare bleeding disorder, which is characterized by a lack of platelet aggregation. It is characterized by qualitative or quantitative abnormalities of the platelet membrane glycoprotein IIb/IIIa. Physiologically, this platelet receptor normally binds several adhesive plasma proteins, and this facilitates attachment and aggregation of platelets to ensure thrombus formation at sites of vascular injury. The lack of resultant platelet aggregation in GT leads to mucocutaneous bleeding whose manifestation may be clinically variable, ranging from easy bruising to severe and potentially life-threatening hemorrhages. To highlight this rare but potentially life-threating disorder, GT. We report a case of GT that was first detected because of the multiple episodes of gum bleeding. The patient was an 18-year-old girl who presented with a history of repeated episodes of gum bleeding since childhood. Till the first visit to our hospital, she had not been diagnosed with GT despite a history of bleeding tendency, notably purpura in areas of easy bruising, gum bleeding, and prolonged bleeding time after abrasions and insect stings. GT was diagnosed on the basis of prolonged bleeding time, lack of platelet aggregation with adenosine di phosphate, epinephrine and collagen. GT should always be considered as differential diagnosis while evaluating any case of bleeding disorder.

A Rare Case of Bleeding Disorder: Glanzmann's Thrombasthenia

PubMed Central

Swathi, Jami; Gowrishankar, A.; Jayakumar, S. A.; Jain, Karun

2017-01-01

Background: Glanzmann's thrombasthenia (GT) is a rare bleeding disorder, which is characterized by a lack of platelet aggregation. It is characterized by qualitative or quantitative abnormalities of the platelet membrane glycoprotein IIb/IIIa. Physiologically, this platelet receptor normally binds several adhesive plasma proteins, and this facilitates attachment and aggregation of platelets to ensure thrombus formation at sites of vascular injury. The lack of resultant platelet aggregation in GT leads to mucocutaneous bleeding whose manifestation may be clinically variable, ranging from easy bruising to severe and potentially life-threatening hemorrhages. Objective: To highlight this rare but potentially life-threating disorder, GT. Case Report: We report a case of GT that was first detected because of the multiple episodes of gum bleeding. The patient was an 18-year-old girl who presented with a history of repeated episodes of gum bleeding since childhood. Till the first visit to our hospital, she had not been diagnosed with GT despite a history of bleeding tendency, notably purpura in areas of easy bruising, gum bleeding, and prolonged bleeding time after abrasions and insect stings. GT was diagnosed on the basis of prolonged bleeding time, lack of platelet aggregation with adenosine di phosphate, epinephrine and collagen. Conclusion: GT should always be considered as differential diagnosis while evaluating any case of bleeding disorder. PMID:29063905

[Antithrombotic therapy and nonvariceal upper gastrointestinal bleeding].

PubMed

Belanová, Veronika; Gřiva, Martin

2015-12-01

The incidence of acute upper gastrointestinal bleeding is about 85-108/100,000 inhabitants per year, nonvariceal bleeding accounts for 80-90%. Antiplatelet and anticoagulation treatment are the significant risk factors for upper gastrointestinal bleeding. To evaluate the occurrence of upper gastrointestinal bleeding in the general community of patients in a county hospital. And to compare the role played by antiplatelet and anticoagulation drugs and other risk medication. Retrospective analysis of patients over 18 years of age who underwent endoscopy for acute upper gastrointestinal bleeding or anaemia (haemoglobin<100 g/l) with proved source of blood losses in upper gastrointestinal tract during a hospital stay in 2013 (from January to June). We included 111 patients of average age 69±15 years, men 60%. Nonvariceal bleeding accounted for 90% of the cases. None of the patients with variceal bleeding (10% of patients) took antiplatelet or anticoagulation therapy. There were 100 patients with nonvariceal bleeding of average age 70±15, 61% men. With the symptoms of acute bleeding (hematemesis, melena) presented in 73% of patients. The most frequent cause of bleeding was gastric and duodenal ulcer (54%). 32% of patients with nonvariceal bleeding had antiplatelets, 19% anticoagulants and 10% used nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors or corticosteroids. 30-days mortality of patients with nonvariceal bleeding was 11%, annual mortality was 23%. There was no significant difference in mortality, blood transfusion requirements or surgical intervention between the patients with antithrombotic agents and without them. 25% of patients (8 patients) using acetylsalicylic acid did not fulfil the indication for this treatment. Among the patients examined by endoscopy for symptomatic nonvariceal bleeding and/or anaemia (haemoglobin<100 g/l) significantly higher portions of patients are taking antiplatelet rather than anticoagulation therapy. This may be caused by greater use of these drugs in the population, but on the other hand it may reflect an association with greater risk of gastrointestinal bleeding. With regard to that, it is alarming, that there still exists a nonnegligible percentage of patients taking acetylsalicylic acid even though they do not meet the indication for the prescription according to the guidelines.

Efficacy of combined intravenous immunoglobulins and steroids in children with primary immune thrombocytopenia and persistent bleeding symptoms

PubMed Central

Parodi, Emilia; Giordano, Paola; Rivetti, Elisa; Giraudo, Maria Teresa; Ansaldi, Giulia; Davitto, Mirella; Mondino, Anna; Farruggia, Piero; Amendola, Giovanni; Matarese, Sofia M.R.; Rossi, Francesca; Russo, Giovanna; Ramenghi, Ugo

2014-01-01

Background The aim of this study was to investigate the effect of the combined administration of intravenous immunoglobulins and steroids as a second-line therapy in 34 children with primary immune thrombocytopenia and persistent, symptomatic bleeding. Materials and methods Combined therapy (intravenous immunoglobulins 0.4 g/kg daily on days 1 and 2, and methylprednisolone 20 mg/kg daily on days 1–3) was administered to 12 patients with newly diagnosed ITP who did not respond to the administration of a single therapy (either intravenous immunoglobulins or steroids) and to 22 children with persistent and chronic disease who required frequent administrations (i.e. more frequently than every 30 days) of either immunoglobulins or steroids (at the same standard dosages) in order to control active bleeding. Results A response (i.e. platelet count >50×109/L and remission of active bleeding) was observed in 8/12 (67%) patients with newly diagnosed ITP. The clinical presentation of responders and non-responders did not differ apparently. Patients in the chronic/persistent phase of disease had a significantly longer median period of remission from symptoms compared with the previous longest period of remission (p=0.016). The treatment was well tolerated. Discussion Our data suggest that the combined approach described is a well-tolerated therapeutic option for children with primary immune thrombocytopenia and persistent bleeding symptoms that can be used in both emergency and/or maintenance settings. PMID:24887226

Retrospective analysis of surgery and trans-arterial embolization for major non-variceal upper gastrointestinal bleeding.

PubMed

Griffiths, Ewen A; McDonald, Chris R; Bryant, Robert V; Devitt, Peter G; Bright, Tim; Holloway, Richard H; Thompson, Sarah K

2016-05-01

With proton pump inhibitors and current sophisticated endoscopic techniques, the number of patients requiring surgical intervention for upper gastrointestinal bleeding has decreased considerably while trans-arterial embolization is being used more often. There are few direct comparisons between the effectiveness of surgery and embolization. A retrospective study of patients from two Australian teaching hospitals who had surgery or trans-arterial embolization (n = 103) for severe upper gastrointestinal haemorrhage between 2004 and 2012 was carried out. Patient demographics, co-morbidities, disease pathology, length of stay, complications, and overall clinical outcome and mortality were compared. There were 65 men and 38 women. The median age was 70 (range 36-95) years. Patients requiring emergency surgical intervention (n = 79) or trans-arterial embolization (n = 24) were compared. The rate of re-bleeding after embolization (42%) was significantly higher compared with the surgery group (19%) (P = 0.02). The requirement for further intervention (either surgery or embolization) was also higher in the embolization group (33%) compared with the surgery group (13%) (P = 0.03). There was no statistical difference in mortality between the embolization group (5/24, 20.8%) and the surgical group (13/79, 16.5%) (P = 0.75). Emergency surgery and embolization are required in 2.6% of patients with upper gastrointestinal bleeding. Both techniques have high mortalities reflecting the age, co-morbidities and severity of bleeding in this patient group. © 2014 Royal Australasian College of Surgeons.