21 CFR 607.30 - Updating blood product listing information.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Updating blood product listing information. 607.30... (CONTINUED) BIOLOGICS ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.30 Updating blood product...

21 CFR 607.30 - Updating blood product listing information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Updating blood product listing information. 607.30... (CONTINUED) BIOLOGICS ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.30 Updating blood product...

49 CFR 1313.8 - Contract summary for grain products-not involving a port.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Contract summary for grain products-not involving... RAILROAD CONTRACTS FOR THE TRANSPORTATION OF AGRICULTURAL PRODUCTS § 1313.8 Contract summary for grain... grain products that does not involve service to or from a port must contain the information specified in...

21 CFR 607.65 - Exemptions for blood product establishments.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for further manufacturing use, or preparation of red blood cells for transfusion are not acts... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Exemptions for blood product establishments. 607... BLOOD AND BLOOD PRODUCTS Exemptions § 607.65 Exemptions for blood product establishments. The following...

21 CFR 607.65 - Exemptions for blood product establishments.

Code of Federal Regulations, 2013 CFR

2013-04-01

... for further manufacturing use, or preparation of red blood cells for transfusion are not acts... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Exemptions for blood product establishments. 607... BLOOD AND BLOOD PRODUCTS Exemptions § 607.65 Exemptions for blood product establishments. The following...

21 CFR 607.65 - Exemptions for blood product establishments.

Code of Federal Regulations, 2014 CFR

2014-04-01

... for further manufacturing use, or preparation of red blood cells for transfusion are not acts... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Exemptions for blood product establishments. 607... BLOOD AND BLOOD PRODUCTS Exemptions § 607.65 Exemptions for blood product establishments. The following...

21 CFR 607.65 - Exemptions for blood product establishments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for further manufacturing use, or preparation of red blood cells for transfusion are not acts... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Exemptions for blood product establishments. 607... BLOOD AND BLOOD PRODUCTS Exemptions § 607.65 Exemptions for blood product establishments. The following...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.

PubMed

Vostal, Jaroslav G; Buehler, Paul W; Gelderman, Monique P; Alayash, Abdu I; Doctor, Alan; Zimring, James C; Glynn, Simone A; Hess, John R; Klein, Harvey; Acker, Jason P; Spinella, Philip C; D'Alessandro, Angelo; Palsson, Bernhard; Raife, Thomas J; Busch, Michael P; McMahon, Timothy J; Intaglietta, Marcos; Swartz, Harold M; Dubick, Michael A; Cardin, Sylvain; Patel, Rakesh P; Natanson, Charles; Weisel, John W; Muszynski, Jennifer A; Norris, Philip J; Ness, Paul M

2018-01-01

The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy. © 2017 AABB.

Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD).

PubMed

2012-11-01

All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63·12, 58·13 and 28·72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of self-sufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO. © 2012 World Health Organization. Vox Sanguinis © 2012 International Society of Blood Transfusion.

Update on the use of blood and blood products in ruminants.

PubMed

Balcomb, Christie; Foster, Derek

2014-07-01

The use of whole blood and/or blood products is indicated in ruminant medicine. The goal of this article is to summarize previous literature on blood groups in ruminants and camelids, list indications for transfusion, and describe collection and transfusion techniques applicable to small ruminants and cattle that can be used in practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Splitting blood and blood product packaging reduces donor exposure for patients undergoing cardiopulmonary bypass.

PubMed

Nuszkowski, M M; Jonas, R A; Zurakowski, D; Deutsch, N

2015-11-01

Cardiopulmonary bypass for congenital heart surgery requires packed red cells (PRBC) and fresh frozen plasma (FFP) to be available, both for priming of the circuit as well as to replace blood loss. This study examines the hypothesis that splitting one unit of packed red blood cells and one unit of fresh frozen plasma into two half units reduces blood product exposure and wastage in the Operating Room. Beginning August 2013, the blood bank at Children's National Medical Center began splitting one unit of packed red blood cells (PRBC) and one unit of fresh frozen plasma (FFP) for patients undergoing cardiopulmonary bypass (CPB). The 283 patients who utilized CPB during calendar year 2013 were divided into 2 study groups: before the split and after the split. The principal endpoints were blood product usage and donor exposure intra-operatively and within 72 hours post-operatively. There was a significant decrease in median total donor exposures for FFP and cryoprecipitate from 5 to 4 per case (p = 0.007, Mann-Whitney U-test). However, there was no difference in the volume of blood and blood products used; in fact, there was a significant increase in the amount of FFP that was wasted with the switch to splitting the unit of FFP. We found that modification of blood product packaging can decrease donor exposure. Future investigation is needed as to how to modify packaging to minimize wastage. © The Author(s) 2015.

AgRISTARS: Foreign commodity production forecasting. Country summary report, Australia

NASA Technical Reports Server (NTRS)

Henninger, D. L.; Reed, C. R. (Principal Investigator)

1981-01-01

Australia is one of the world's major growers and exporters of wheat and as such is one of the countries of interest in the AgRISTARS program which endeavors to develop technology to estimate crop production using aerospace remote sensing. A compilation of geographic, political, and agricultural information on Australia is presented. Also included is a summary of the aerospace remote sensing, meteorological, and ground-observed data which were collected with respect to Australia, as well as a summary of contacts between AgRISTARS and Australia personnel.

21 CFR 607.65 - Exemptions for blood product establishments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... use, or preparation of red blood cells for transfusion are not acts requiring such transfusion... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Exemptions for blood product establishments. 607.65... (CONTINUED) BIOLOGICS ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND...

21 CFR 607.37 - Inspection of establishment registrations and blood product listings.

Code of Federal Regulations, 2014 CFR

2014-04-01

... blood product listings. 607.37 Section 607.37 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.37 Inspection of establishment registrations and blood product listings. (a) A copy of the Form FD-2830 (Blood...

21 CFR 607.37 - Inspection of establishment registrations and blood product listings.

Code of Federal Regulations, 2013 CFR

2013-04-01

... blood product listings. 607.37 Section 607.37 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.37 Inspection of establishment registrations and blood product listings. (a) A copy of the Form FD-2830 (Blood...

21 CFR 607.37 - Inspection of establishment registrations and blood product listings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... blood product listings. 607.37 Section 607.37 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.37 Inspection of establishment registrations and blood product listings. (a) A copy of the Form FD-2830 (Blood...

Summary of strategies for planning Productivity Improvement and Quality Enhancement (PIQE)

NASA Technical Reports Server (NTRS)

1986-01-01

The Summary of NASA Strategies for Productivity Improvement and Quality Enhancement respond to NASA's eighth top goal: Establish NASA as a leader in the development and application of advanced technology and management practices which contribute to significant increases in both Agency and national productivity. The Strategies provide the framework for development of the agency-wide Productivity Improvement and Quality Enhancement (PIQE) Plans.

76 FR 39405 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... blood donors and its implications for selective testing of blood donors. On August 3, 2011, the...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

Blood product transfusion and wastage rates in obstetric hemorrhage.

PubMed

Yazer, Mark H; Dunbar, Nancy M; Cohn, Claudia; Dillon, Jessica; Eldib, Howida; Jackson, Bryon; Kaufman, Richard; Murphy, Michael F; O'Brien, Kerry; Raval, Jay S; Seheult, Jansen; Staves, Julie; Waters, Jonathan H

2018-03-07

Bleeding emergencies can complicate pregnancies. Understanding the disposition of the products that are issued in this clinical setting can help inform inventory levels at hospitals where obstetric patients are seen. Patients who had an obstetric hemorrhage of any etiology between January 2013 and June 2017, and whose resuscitation began with uncrossmatched red blood cells (RBCs) or emergency-issued plasma or platelets (PLT), were included. The disposition of all blood products issued within 6 hours of the first uncrossmatched or emergency-issued product was documented, as was basic patient demographic information. In total, 301 women with an obstetric hemorrhage from seven academic institutions were identified. Their mean ± standard deviation age was 30.9 ± 6.1 years, 45.2% delivered by Cesarean section, and 40.5% delivered vaginally, while 12% did not deliver. The largest single etiology of hemorrhage was related to abnormal placentation. Of the 2280 issued RBC units, 55% were transfused, 43% were returned, and 2% were wasted. The rates of transfusion of the other blood products ranged from 58% for plasma units to 82% for cryoprecipitate. Seventeen percent of the issued cryoprecipitate units were wasted, the highest of any blood product. The rate of a patient receiving a transfusion when at least one blood product had been ordered ranged from 74% for PLTs to 91% for cryoprecipitate. Although the rates of receiving a transfusion of at least one blood product when one is ordered was high, many of the issued units were returned, especially for RBCs. © 2018 AABB.

21 CFR 607.21 - Times for establishment registration and blood product listing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Times for establishment registration and blood... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.21 Times for establishment registration and blood product listing. The owner or operator of an...

21 CFR 607.21 - Times for establishment registration and blood product listing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Times for establishment registration and blood... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.21 Times for establishment registration and blood product listing. The owner or operator of an...

21 CFR 607.21 - Times for establishment registration and blood product listing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Times for establishment registration and blood... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.21 Times for establishment registration and blood product listing. The owner or operator of an...

21 CFR 607.21 - Times for establishment registration and blood product listing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Times for establishment registration and blood... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.21 Times for establishment registration and blood product listing. The owner or operator of an...

21 CFR 607.21 - Times for establishment registration and blood product listing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Times for establishment registration and blood... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.21 Times for establishment registration and blood product listing. The owner or operator of an...

75 FR 35494 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... transfusions and the status of laboratory tests. On July 27, 2010, the committee will discuss blood donor...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

21 CFR 607.25 - Information required for establishment registration and blood product listing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... registration and blood product listing. 607.25 Section 607.25 Food and Drugs FOOD AND DRUG ADMINISTRATION... FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.25 Information required for establishment registration and blood product listing. (a) Form...

21 CFR 607.25 - Information required for establishment registration and blood product listing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... registration and blood product listing. 607.25 Section 607.25 Food and Drugs FOOD AND DRUG ADMINISTRATION... FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.25 Information required for establishment registration and blood product listing. (a) Form...

21 CFR 607.25 - Information required for establishment registration and blood product listing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... registration and blood product listing. 607.25 Section 607.25 Food and Drugs FOOD AND DRUG ADMINISTRATION... FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.25 Information required for establishment registration and blood product listing. (a) Form...

A rational framework for production decision making in blood establishments.

PubMed

Ramoa, Augusto; Maia, Salomé; Lourenço, Anália

2012-07-24

SAD_BaSe is a blood bank data analysis software, created to assist in the management of blood donations and the blood production chain in blood establishments. In particular, the system keeps track of several collection and production indicators, enables the definition of collection and production strategies, and the measurement of quality indicators required by the Quality Management System regulating the general operation of blood establishments. This paper describes the general scenario of blood establishments and its main requirements in terms of data management and analysis. It presents the architecture of SAD_BaSe and identifies its main contributions. Specifically, it brings forward the generation of customized reports driven by decision making needs and the use of data mining techniques in the analysis of donor suspensions and donation discards.

A Rational Framework for Production Decision Making in Blood Establishments.

PubMed

Ramoa, Augusto; Maia, Salomé; Lourenço, Anália

2012-12-01

SAD_BaSe is a blood bank data analysis software, created to assist in the management of blood donations and the blood production chain in blood establishments. In particular, the system keeps track of several collection and production indicators, enables the definition of collection and production strategies, and the measurement of quality indicators required by the Quality Management System regulating the general operation of blood establishments. This paper describes the general scenario of blood establishments and its main requirements in terms of data management and analysis. It presents the architecture of SAD_BaSe and identifies its main contributions. Specifically, it brings forward the generation of customized reports driven by decision making needs and the use of data mining techniques in the analysis of donor suspensions and donation discards.

Accurate costs of blood transfusion: a microcosting of administering blood products in the United Kingdom National Health Service.

PubMed

Stokes, Elizabeth A; Wordsworth, Sarah; Staves, Julie; Mundy, Nicola; Skelly, Jane; Radford, Kelly; Stanworth, Simon J

2018-04-01

In an environment of limited health care resources, it is crucial for health care systems which provide blood transfusion to have accurate and comprehensive information on the costs of transfusion, incorporating not only the costs of blood products, but also their administration. Unfortunately, in many countries accurate costs for administering blood are not available. Our study aimed to generate comprehensive estimates of the costs of administering transfusions for the UK National Health Service. A detailed microcosting study was used to cost two key inputs into transfusion: transfusion laboratory and nursing inputs. For each input, data collection forms were developed to capture staff time, equipment, and consumables associated with each step in the transfusion process. Costing results were combined with costs of blood product wastage to calculate the cost per unit transfused, separately for different blood products. Data were collected in 2014/15 British pounds and converted to US dollars. A total of 438 data collection forms were completed by 74 staff. The cost of administering blood was $71 (£49) per unit for red blood cells, $84 (£58) for platelets, $55 (£38) for fresh-frozen plasma, and $72 (£49) for cryoprecipitate. Blood administration costs add substantially to the costs of the blood products themselves. These are frequently incurred costs; applying estimates to the blood components supplied to UK hospitals in 2015, the annual cost of blood administration, excluding blood products, exceeds $175 (£120) million. These results provide more accurate estimates of the total costs of transfusion than those previously available. © 2018 AABB.

21 CFR 607.20 - Who must register and submit a blood product list.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Who must register and submit a blood product list... BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.20 Who must register and submit a blood product list. (a) Owners or operators of all establishments, not exempt under...

21 CFR 607.20 - Who must register and submit a blood product list.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Who must register and submit a blood product list... BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.20 Who must register and submit a blood product list. (a) Owners or operators of all establishments, not exempt under...

21 CFR 607.20 - Who must register and submit a blood product list.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Who must register and submit a blood product list... BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.20 Who must register and submit a blood product list. (a) Owners or operators of all establishments, not exempt under...

21 CFR 607.20 - Who must register and submit a blood product list.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Who must register and submit a blood product list... BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.20 Who must register and submit a blood product list. (a) Owners or operators of all establishments, not exempt under...

21 CFR 607.20 - Who must register and submit a blood product list.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Who must register and submit a blood product list... BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.20 Who must register and submit a blood product list. (a) Owners or operators of all establishments, not exempt under...

Summary of Public Comments and Responses for Final NESHAP for Pharmaceuticals Production

EPA Pesticide Factsheets

This document provides summaries of public comments and EPA responses related to the final standards for the reduction of hazardous air pollutants (HAP) emitted through the manufacture of pharmaceutical products

Strategies to reduce blood product utilization in obstetric practice.

PubMed

Neb, Holger; Zacharowski, Kai; Meybohm, Patrick

2017-06-01

Patient blood management (PBM) aims to improve patient outcome and safety by reducing the number of unnecessary RBC transfusions and vitalizing patient-specific anemia reserves. Although PBM is increasingly recognized as best clinical practice in elective surgery, implementation of PBM is restrained in the setting of obstetrics. This review summarizes recent findings to reduce blood product utilization in obstetric practice. PBM-related evidence-based benefits should be urgently adopted in the field of obstetric medicine. Intravenous iron can be considered a safe, effective strategy to replenish iron stores and to correct both pregnancy-related and hemorrhage-related iron deficiency anemia. In addition to surgical techniques and the use of uterotonics, recent findings support early administration of tranexamic acid, fibrinogen and a coagulation factor concentrate-based, viscoelastically guided practice in case of peripartum hemorrhage to manage coagulopathy. In patients with cesarean section, autologous red cell blood salvage may reduce blood product utilization, although its use in this setting is controversial. Implementation of PBM in obstetric practice offers large potential to reduce blood loss and transfusion requirements of allogeneic blood products, even though large clinical trials are lacking in this specific field. Intravenous iron supplementation may be suggested to increase peripartum hemoglobin levels. Additionally, tranexamic acid and point-of-care-guided supplementation of coagulation factors are potent methods to reduce unnecessary blood loss and blood transfusions in obstetrics.

Australian experience with frozen blood products on military operations.

PubMed

Neuhaus, Susan J; Wishaw, Ken; Lelkens, Charles

2010-02-15

Historically, the Australian Defence Force (ADF) has sourced all its blood supplies from the Australian Red Cross Blood Service. Recent ADF operations in the Middle East have highlighted a need to rely on other nations' blood supply systems. In 2008, the ADF embedded a surgical and intensive care team into the Netherlands-led forward health facility at the Uruzgan Medical Centre at Tarin Kowt in Afghanistan. To date, three teams have provided 2-month rotations as part of the North Atlantic Treaty Organization International Security Assistance Force in Afghanistan. The Netherlands armed forces use a sophisticated system for supply of liquid and frozen blood products (frozen red cells, plasma and platelets). We review Australian experience with the Dutch system of supplying blood products for major trauma resuscitation in Afghanistan.

21 CFR 607.22 - How and where to register establishments and list blood products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... blood products. 607.22 Section 607.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.22 How and where to register establishments and list blood products. (a) The first registration of an...

21 CFR 607.22 - How and where to register establishments and list blood products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... blood products. 607.22 Section 607.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.22 How and where to register establishments and list blood products. (a) The first registration of an...

21 CFR 607.22 - How and where to register establishments and list blood products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... blood products. 607.22 Section 607.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.22 How and where to register establishments and list blood products. (a) The first registration of an...

Frozen blood products: clinically effective and potentially ideal for remote Australia.

PubMed

Holley, A; Marks, D C; Johnson, L; Reade, M C; Badloe, J F; Noorman, F

2013-01-01

The development of effective cryopreservation techniques for both red blood cells and platelets, which maintain ex vivo biological activity, in combination with frozen plasma, provides for a unique blood banking strategy. This technology greatly enhances the storage life of these products. The rationale and potential advantages of using cryopreservation techniques for the provision of blood products to remote and military environments have been effectively demonstrated in several conflicts over the last decade. Current haemostatic resuscitation doctrine for the exsanguinating patient supports the use of red blood cells, platelets and frozen plasma early in the resuscitation. We believe an integrated fresh-frozen blood bank inventory could facilitate provision of blood products, not only in the military setting but also in regional Australia, by overcoming many logistic and geographical challenges. The processes involved in production and point of care thawing are sufficiently well developed and achievable to make this technology a viable option. The potential limitations of cryopreservation and subsequent product thawing need to be considered if such a strategy is to be developed. A substantial body of international experience using cryopreserved products in remote settings has already been accrued. This experience provides a template for the possible creation of an Australian integrated fresh-frozen blood bank inventory that could conceivably enhance the care of patients in both regional Australia and in the military setting.

Erythroid cells in vitro: from developmental biology to blood transfusion products.

PubMed

Migliaccio, Anna Rita; Whitsett, Carolyn; Migliaccio, Giovanni

2009-07-01

Red blood cells (RBCs) transfusion plays a critical role in numerous therapies. Disruption of blood collection by political unrest, natural disasters and emerging infections and implementation of restrictions on the use of erythropoiesis-stimulating agents in cancer may impact blood availability in the near future. These considerations highlight the importance of developing alternative blood products. Knowledge about the processes that control RBC production has been applied to the establishment of culture conditions allowing ex-vivo generation of RBCs in numbers close to those (2.5 x 10 cells/ml) present in a transfusion, from cord blood, donated blood units or embryonic stem cells. In addition, experimental studies demonstrate that such cells protect mice from lethal bleeding. Therefore, erythroid cells generated ex vivo may be suitable for transfusion provided they can be produced safely in adequate numbers. However, much remains to be done to translate a theoretical production of approximately 2.5 x 10 RBCs in the laboratory into a 'clinical grade production process'. This review summarizes the state-of-the-art in establishing ex-vivo culture conditions for erythroid cells and discusses the most compelling issues to be addressed to translate this progress into a clinical grade transfusion product.

[Qualitative evaluation of blood products records in a hospital].

PubMed

Lartigue, B; Catillon, E

2012-02-01

This study aimed at evaluating the qualitative performance of blood products traceability from paper and electronic medical records in a hospital. Quality of date/time documentation was assessed by detection, for 20minutes or more, of chronological errors and inter-source inconsistencies, in a random sample of 168 blood products transfused during 2009. A receipt date/time was confirmed in 52% of paper records; a data entry error was attested in 25% of paper records, and 21% of electronic records. A transfusion date/time was notified in 93% of paper records, with a data entry error in 26% of paper records and 25% of electronic records. The patient medical record held at least one date/time error in 18% and 17%, for receipt and transfusion respectively. Environmental factors (clinical setting, urgency, blood product category) did not contributed to data error rates. Although blood products traceability has good quantitative results, the recorded documentation is not qualitative. In our study, data entry errors are similar in electronic or paper records, but the global failure rate is lesser in electronic records because omissions are controlled. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

78 FR 2677 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...

Parvovirus transmission by blood products - a cause for concern?

PubMed

Norja, Päivi; Lassila, Riitta; Makris, Mike

2012-11-01

The introduction of dual viral inactivation of clotting factor concentrates has practically eliminated infections by viruses associated with significant pathogenicity over the last 20 years. Despite this, theoretical concerns about transmission of infection have remained, as it is known that currently available viral inactivation methods are unable to eliminate parvovirus B19 or prions from these products. Recently, concern has been raised following the identification of the new parvoviruses, human parvovirus 4 (PARV4) and new genotypes of parvovirus B19, in blood products. Parvoviruses do not cause chronic pathogenicity similar to human immunodeficiency virus or hepatitis C virus, but nevertheless may cause clinical manifestations, especially in immunosuppressed patients. Manufacturers should institute measures, such as minipool polymerase chain reaction testing, to ensure that their products contain no known viruses. So far, human bocavirus, another new genus of parvovirus, has not been detected in fractionated blood products, and unless their presence can be demonstrated, routine testing during manufacture is not essential. Continued surveillance of the patients and of the safety of blood products remains an important ongoing issue. © 2012 Blackwell Publishing Ltd.

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of registrant; blood product... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product Establishments § 607.35 Notification of registrant; blood product establishment registration number and NDC...

77 FR 29667 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

Improving appropriateness of blood utilization through prospective review of requests for blood products: the role of pathology residents as consultants.

PubMed

Haldiman, Lindsey; Zia, Hamid; Singh, Gurmukh

2014-01-01

To evaluate the effectiveness of prospective review of orders for fresh-frozen plasma (FFP) and platelets in reducing blood-product use, and of the effectiveness of preparing pathology residents to serve as clinical consultants. At our 572-bed tertiary-care hospital, we developed guidelines for the use of blood products in collaboration with a variety of departments. For patients whose condition(s) met generally accepted criteria, we identified trigger points to allow for quick release by blood bank staff of blood products. For patients whose condition(s) did not meet the applicable criteria, the on-call pathology resident reviewed the medical record of that patient to determine whether there were any extenuating circumstances; consulted with the ordering physician and attending pathologist, as needed; and advised the house staff on appropriate use of blood products. We evaluated the change in use of blood products between the years 2009 and 2012 to assess the effectiveness of the program. We observed a decrease of 38.8% and 31.4% in the use of FFP and platelets, respectively (29.7% and 21.1%, respectively, when normalized for the number of discharges). If projected to the national level, this improvement would translate to an annual cost reduction of approximately $130 million. Prospective review of orders for blood products can significantly improve use of these products, thereby reducing risk to patients and avoiding unnecessary healthcare costs. The involvement of pathology residents in the prospective review process provides an excellent opportunity for their training as laboratory consultants. Copyright© by the American Society for Clinical Pathology (ASCP).

Blood and Blood Product Conservation: Results of Strategies to Improve Clinical Outcomes in Open Heart Surgery Patients at a Tertiary Hospital.

PubMed

Khan, Junaid H; Green, Emily A; Chang, Jimmin; Ayala, Alexandria M; Barkin, Marilyn S; Reinys, Emily E; Stanton, Jeffrey; Stanten, Russell D

2017-12-01

Blood product usage is a quality outcome for patients undergoing cardiac surgery. To address an increase in blood product usage since the discontinuation of aprotinin, blood conservation strategies were initiated at a tertiary hospital in Oakland, CA. Improving transfusion rates for open heart surgery patients requiring Cardiopulmonary bypass (CPB) involved multiple departments in coordination. Specific changes to conserve blood product usage included advanced CPB technology upgrades, and precise individualized heparin dose response titration assay for heparin and protamine management. Retrospective analysis of blood product usage pre-implementation, post-CPB changes and post-Hemostasis Management System (HMS) implementation was done to determine the effectiveness of the blood conservation strategies. Statistically significant decrease in packed red blood cells, fresh frozen plasma, cryoprecipitate, and platelet usage over the stepped implementation of both technologies was observed. New oxygenator and centrifugal pump technologies reduced active circuitry volume and caused less damage to blood cells. Individualizing heparin and protamine dosing to a patient using the HMS led to transfusion reductions as well. Overall trends toward reductions in hospital length of stay and intensive care unit stay, and as a result, blood product cost and total hospitalization cost are positive over the period of implementation of both CPB circuit changes and HMS implementation. Although they are multifactorial in nature, these trends provide positive enforcement to the changes implemented.

75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, CBER, FDA. FDA...

77 FR 67013 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

..., 2012, the Committee will meet in open session to discuss labeling of Red Blood Cells with historical...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Blood...

TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage.

PubMed

Fleming, Kevin; Redfern, Roberta E; March, Rebekah L; Bobulski, Nathan; Kuehne, Michael; Chen, John T; Moront, Michael

2017-12-01

Complex cardiac procedures often require blood transfusion because of surgical bleeding or coagulopathy. Thrombelastography (TEG) was introduced in our institution to direct transfusion management in cardiothoracic surgery. The goal of this study was to quantify the effect of TEG on transfusion rates peri- and postoperatively. All patients who underwent complex cardiac surgery, defined as open multiple valve repair/replacement, coronary artery bypass grafting with open valve repair/replacement, or aortic root/arch repair before and after implementation of TEG were identified and retrospectively analyzed. Minimally invasive cases were excluded. Patient characteristics and blood use were compared with t test and chi-square test. A generalized linear model including patient characteristics, preoperative and postoperative lab values, and autotransfusion volume was used to determine the impact of TEG on perioperative, postoperative, and total blood use. In total, 681 patients were identified, 370 in the pre-TEG period and 311 patients post-TEG. Patient demographics were not significantly different between periods. Mean units of red blood cells, plasma, and cryoprecipitate were significantly reduced after TEG was implemented (all, p < .0001); use of platelets was reduced but did not reach significance. Mean units of all blood products in the perioperative period and over the entire stay were reduced by approximately 40% (both, p < .0001). Total proportion of patients exposed to transfusion was significantly lower after introduction of TEG ( p < .01). Controlling for related factors on multivariate analysis, such as preoperative laboratory values and autotransfusion volume, use of TEG was associated with significant reduction in perioperative and overall blood product transfusion. TEG-directed management of blood product administration during complex cardiac surgeries significantly reduced the units of blood products received perioperatively but not blood usage more than

Drone transportation of blood products.

PubMed

Amukele, Timothy; Ness, Paul M; Tobian, Aaron A R; Boyd, Joan; Street, Jeff

2017-03-01

Small civilian unmanned aerial vehicles (drones) are a novel way to transport small goods. To the best of our knowledge there are no studies examining the impact of drone transport on blood products, describing approaches to maintaining temperature control, or component physical characteristics during drone transport. Six leukoreduced red blood cell (RBC) and six apheresis platelet (PLT) units were split using sterile techniques. The larger parent RBC and PLT units, as well as six unthawed plasma units frozen within 24 hours of collection (FP24), were placed in a cooler, attached to the drone, and flown for up to 26.5 minutes with temperature logging. Ambient temperatures during the experimental window ranged between -1 and 18°C across 2 days. The difference between the ambient and unit temperatures was approximately 20°C for PLT and FP24 units. After flight, the RBC parent units were centrifuged and visually checked for hemolysis; the PLTs were checked for changes in mean PLT volumes (MPVs), pH, and PLT count; and the frozen air bubbles on the back of the FP24 units were examined for any changes in size or shape, as evidence of thawing. There was no evidence of RBC hemolysis; no significant changes in PLT count, pH, or MPVs; and no changes in the FP24 bubbles. The temperature of all units was maintained during transport and flight. There was no adverse impact of drone transport on RBC, PLT, or FP24 units. These findings suggest that drone transportation systems are a viable option for the transportation of blood products. © 2016 AABB.

Prehospital Blood Product Administration Opportunities in Ground Transport ALS EMS - A Descriptive Study.

PubMed

Mix, Felicia M; Zielinski, Martin D; Myers, Lucas A; Berns, Kathy S; Luke, Anurahda; Stubbs, James R; Zietlow, Scott P; Jenkins, Donald H; Sztajnkrycer, Matthew D

2018-06-01

IntroductionHemorrhage remains the major cause of preventable death after trauma. Recent data suggest that earlier blood product administration may improve outcomes. The purpose of this study was to determine whether opportunities exist for blood product transfusion by ground Emergency Medical Services (EMS). This was a single EMS agency retrospective study of ground and helicopter responses from January 1, 2011 through December 31, 2015 for adult trauma patients transported from the scene of injury who met predetermined hemodynamic (HD) parameters for potential transfusion (heart rate [HR]≥120 and/or systolic blood pressure [SBP]≤90). A total of 7,900 scene trauma ground transports occurred during the study period. Of 420 patients meeting HD criteria for transfusion, 53 (12.6%) had a significant mechanism of injury (MOI). Outcome data were available for 51 patients; 17 received blood products during their emergency department (ED) resuscitation. The percentage of patients receiving blood products based upon HD criteria ranged from 1.0% (HR) to 5.9% (SBP) to 38.1% (HR+SBP). In all, 74 Helicopter EMS (HEMS) transports met HD criteria for blood transfusion, of which, 28 patients received prehospital blood transfusion. Statistically significant total patient care time differences were noted for both the HR and the SBP cohorts, with HEMS having longer time intervals; no statistically significant difference in mean total patient care time was noted in the HR+SBP cohort. In this study population, HD parameters alone did not predict need for ED blood product administration. Despite longer transport times, only one-third of HEMS patients meeting HD criteria for blood administration received prehospital transfusion. While one-third of ground Advanced Life Support (ALS) transport patients manifesting HD compromise received blood products in the ED, this represented 0.2% of total trauma transports over the study period. Given complex logistical issues involved in

Dietary supplements and related products: a brief summary.

PubMed

Rapaka, Rao S; Coates, Paul M

2006-03-27

We were gratified by the interest expressed in publishing a large number of presentations from the NIDA organized Workshop on "Natureceuticals (Natural Products), Nutraceuticals, Herbal Botanicals, Psychoactives: Drug Discovery and Drug-Drug Interactions". The number of manuscripts received necessitated two volumes of proceedings. In this brief summary of the second volume, we present an introduction to the roles of organizations such as National Center for Complementary and Alternate Medicine and Office of Dietary Supplements, both at the National Institutes of Health, and the Food and Drug Administration. These agencies are involved in research and regulation of dietary supplements and related products. Next, a brief summary of each of the fifteen articles is provided. The first four articles are related to regulatory and standardization aspects: issues related to botanicals (Khan); USP and dietary supplements (Srinivasan); dietary supplement reference materials (Sander et al.); and proposed cGMPs and the scientific basis behind the proposed regulations by FDA (Melethil). The next three articles relate to the methodologies employed in research: LC/MS for the pharmacokinetic analysis polyphenols from dietary supplements (Barnes et al.); proteomic analysis of grape seed extract (Kim et al.); and a nematode model, C. elegans, in Alzheimer's and ginkgo biloba extract for mechanistic studies; another model, a hepatocyte tissue culture model for drug herbal interaction, is reviewed later and presented by Venkataramanan. The next four chapters are on specific dietary supplements: green tea and the polyphenolic catechins (Zaveri); curcumin (Maheswari et al.); tocotrienols (alpha-tocotrienol, Sen and Roy), gamma-tocotrienol (Sree Kumar et al.). This topic is followed by drug interaction studies: in vitro and in vivo assessment methodologies (Venkataramanan); flavonoid-drug interactions (Morris); MDR and CYP3A4-mediated drug-herb interaction (Pal and Mitra); and evidence

Simulation-optimization model for production planning in the blood supply chain.

PubMed

Osorio, Andres F; Brailsford, Sally C; Smith, Honora K; Forero-Matiz, Sonia P; Camacho-Rodríguez, Bernardo A

2017-12-01

Production planning in the blood supply chain is a challenging task. Many complex factors such as uncertain supply and demand, blood group proportions, shelf life constraints and different collection and production methods have to be taken into account, and thus advanced methodologies are required for decision making. This paper presents an integrated simulation-optimization model to support both strategic and operational decisions in production planning. Discrete-event simulation is used to represent the flows through the supply chain, incorporating collection, production, storing and distribution. On the other hand, an integer linear optimization model running over a rolling planning horizon is used to support daily decisions, such as the required number of donors, collection methods and production planning. This approach is evaluated using real data from a blood center in Colombia. The results show that, using the proposed model, key indicators such as shortages, outdated units, donors required and cost are improved.

21 CFR 607.7 - Establishment registration and product listing of blood banks and other firms manufacturing human...

Code of Federal Regulations, 2013 CFR

2013-04-01

... blood banks and other firms manufacturing human blood and blood products. 607.7 Section 607.7 Food and... ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS General Provisions § 607.7 Establishment registration and product listing of blood banks and other firms...

21 CFR 607.7 - Establishment registration and product listing of blood banks and other firms manufacturing human...

Code of Federal Regulations, 2012 CFR

2012-04-01

... blood banks and other firms manufacturing human blood and blood products. 607.7 Section 607.7 Food and... ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS General Provisions § 607.7 Establishment registration and product listing of blood banks and other firms...

21 CFR 607.7 - Establishment registration and product listing of blood banks and other firms manufacturing human...

Code of Federal Regulations, 2014 CFR

2014-04-01

... blood banks and other firms manufacturing human blood and blood products. 607.7 Section 607.7 Food and... ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS General Provisions § 607.7 Establishment registration and product listing of blood banks and other firms...

[Logistic and production process in a regional blood center: modeling and analysis].

PubMed

Baesler, Felipe; Martínez, Cristina; Yaksic, Eduardo; Herrera, Claudia

2011-09-01

The blood supply chain is a complex system that considers different interconnected elements that have to be synchronized correctly to satisfy in quality and quantity the final patient requirements. To determine the blood center maximum production capacity, as well as the determination of the necessary changes for a future production capacity expansion. This work was developed in the Blood Center of Concepción, Chile, operations management tools were applied to model it and to propose improvement alternatives for the production process. The use of simulation is highlighted, which permitted the replication of the center behavior and the evaluation of expansion alternatives. It is possible to absorb a 100% increment in blood demand, without making major changes or investments in the production process. Also it was possible to determine the subsequent steps in terms of investments in equipment and human resources for a future expansion of the center coverage. The techniques used to model the production process of the blood center of Concepción, Chile, allowed us to analyze how it operates, to detect "bottle necks", and to support the decision making process for a future expansion of its capacity.

Distribution of di(2-ethylhexyl) phthalate and products in blood and blood components.

PubMed Central

Rock, G; Labow, R S; Tocchi, M

1986-01-01

In order to impart flexibility, plastic medical devices incorporate liquid plasticizers into their structure. Data from several laboratories, including ours, have shown that these compounds leach from blood bags and tubing during collection of blood, storage of various blood components and during kidney dialysis and cell and plasma apheresis procedures. After the plasticizer di(2-ethylhexyl) phthalate leaches from poly(vinyl chloride) blood packs, it is converted by a plasma enzyme to a more toxic metabolite, mono(2-ethylhexyl) phthalate. Blood fractionation products from outdated plasma contain mono(2-ethylhexyl) phthalate, the highest level being found in normal serum albumin. Recently, we have reported that di(2-ethylhexyl) phthalate actually binds to the red blood cell membrane and reduces its osmotic fragility. Current methods of red cells storage, which permit utilization up to 35 days after collection, are not possible without this membrane stabilization. Platelets are now stored for 5 days in the Fenwal PL 732 polyolefin bag. Although stated to be essentially free of liquid plasticizers, a significant level of leaching from this bag into the extracts of stored platelet concentrates was observed. PMID:3709456

9 CFR 310.20 - Saving of blood from livestock as an edible product.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Saving of blood from livestock as an... AND VOLUNTARY INSPECTION AND CERTIFICATION POST-MORTEM INSPECTION § 310.20 Saving of blood from livestock as an edible product. Blood may be saved for edible purposes at official establishments provided...

9 CFR 310.20 - Saving of blood from livestock as an edible product.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Saving of blood from livestock as an... AND VOLUNTARY INSPECTION AND CERTIFICATION POST-MORTEM INSPECTION § 310.20 Saving of blood from livestock as an edible product. Blood may be saved for edible purposes at official establishments provided...

9 CFR 310.20 - Saving of blood from livestock as an edible product.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Saving of blood from livestock as an... AND VOLUNTARY INSPECTION AND CERTIFICATION POST-MORTEM INSPECTION § 310.20 Saving of blood from livestock as an edible product. Blood may be saved for edible purposes at official establishments provided...

9 CFR 310.20 - Saving of blood from livestock as an edible product.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Saving of blood from livestock as an... AND VOLUNTARY INSPECTION AND CERTIFICATION POST-MORTEM INSPECTION § 310.20 Saving of blood from livestock as an edible product. Blood may be saved for edible purposes at official establishments provided...

9 CFR 310.20 - Saving of blood from livestock as an edible product.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Saving of blood from livestock as an... AND VOLUNTARY INSPECTION AND CERTIFICATION POST-MORTEM INSPECTION § 310.20 Saving of blood from livestock as an edible product. Blood may be saved for edible purposes at official establishments provided...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan.

PubMed

Sultan, Sadia; Zaheer, Hasan Abbas; Waheed, Usman; Baig, Mohammad Amjad; Rehan, Asma; Irfan, Syed Mohammed

2018-01-01

Internal quality control (IQC) is the backbone of quality assurance program. In blood banking, the quality control of blood products ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients. The main objective of this study is to analyze the IQC of blood products as an indicator of our blood bank performance. An observational cross-sectional study was conducted at the blood bank of Liaquat National Hospital and Medical College, from January 2014 to December 2015. A total of 100 units of each blood components were arbitrarily chosen during the study. Packed red cell units were evaluated for hematocrit (HCT); random platelet concentrates were evaluated for pH, yield, and culture; fresh frozen plasma (FFP) and cryoprecipitate (CP) were evaluated for unit volume, factor VIII, and fibrinogen concentrations. A total of 400 units were tested for IQC. The mean HCT of packed red cells was 69.5 ± 7.24, and in 98% units, it met the standard (<80% of HCT). The mean platelet yield was 8.8 ± 3.40 × 10 9 /L and pH was ≥6.2 in 98% bags; cultures were negative in 97% of units tested. Mean factor VIII and fibrinogen levels were found to be 84.24 ± 15.01 and 247.17 ± 49.69 for FFP, respectively. For CP, mean factor VIII and fibrinogen level were found to be 178.75 ± 86.30 and 420.7 ± 75.32, respectively. The IQC of blood products at our blood bank is in overall compliance and met recommended international standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit, and staff competencies can improve the quality performance of the transfusion services.

Blood products use in France: a nationwide cross-sectional survey.

PubMed

Fillet, Anne-Marie; Desmarets, Maxime; Assari, Suzanne; Quaranta, Jean-François; François, Anne; Pugin, Aurore; Schuhmacher, Anne; Lassale, Bernard; Monnet, Elisabeth; Cabre, Philippe; Legrand, Dominique; Binda, Delphine; Djoudi, Rachid

2016-12-01

Blood products use has increased in France between 2000 and 2011. To understand the reasons for this increase, data about transfused patients and transfusion practices needed to be updated. A nationwide cross-sectional survey was performed with health care establishments. Diagnoses and indication for the transfusion, pretransfusion laboratory results, and blood products used were collected during a randomly selected 24-hour period in 2011. All patients who received at least one blood product delivered on the survey day were included. A total of 10,794 blood products were requested for 4720 patients: 8688 red blood cell (RBC) units, 842 platelet (PLT) concentrates, and 1264 fresh-frozen plasma (FFP) units. Hematologic and cancer pathologies included 46% of transfused patients, 34% of the patients had transfusions in a surgical context, and 32.4% of transfused patients were receiving medication with an impact on transfusion. Nearly half of RBC transfusions were performed with hemoglobin levels of less than 8 g/dL. PLT transfusions for prophylactic indication were prescribed with PLT counts of less than 20 × 10 9 and 50 × 10 9 /L in 56.9 and 86.6% of patients, respectively. RBCs and PLTs transfusion practices were in agreement with national guidelines. FFP units were involved in 8.0% of all prescriptions. Among these, 57.4% were requested in the context of an acute hemorrhage and 8.4% for plasma exchange. The median of FFP use (n = 2) in a nonsurgical context, excluding plasma exchange, suggests an insufficient dosing of FFP. Except for insufficient FFP dosing per patient and limitations on assessment of indications for prescribing, transfusion practices were in agreement with national guidelines. © 2016 AABB.

Follicle vascularity coordinates corpus luteum blood flow and progesterone production.

PubMed

de Tarso, S G S; Gastal, G D A; Bashir, S T; Gastal, M O; Apgar, G A; Gastal, E L

2017-03-01

Colour Doppler ultrasonography was used to compare the ability of preovulatory follicle (POF) blood flow and its dimensions to predict the size, blood flow and progesterone production capability of the subsequent corpus luteum (CL). Cows (n=30) were submitted to a synchronisation protocol. Follicles ≥7mm were measured and follicular wall blood flow evaluated every 12h for approximately 3.5 days until ovulation. After ovulation, cows were scanned daily for 8 days and similar parameters were evaluated for the CL. Blood samples were collected and plasma progesterone concentrations quantified. All parameters were positively correlated. Correlation values ranged from 0.26 to 0.74 on data normalised to ovulation and from 0.31 to 0.74 on data normalised to maximum values. Correlations between calculated ratios of both POF and CL in data normalised to ovulation and to maximum values ranged from moderate (0.57) to strong (0.87). Significant (P<0.0001) linear regression analyses were seen in all comparisons. In conclusion, higher correlations were observed between the dimensions of POF and/or CL and blood flow of both structures, as well as POF and/or CL blood flow with plasma progesterone concentrations of the resultant CL. These findings indicate that follicle vascularity coordinates CL blood flow and progesterone production in synchronised beef cows.

[Factors associated with the satisfaction of prescribers of blood products in Burkina Faso].

PubMed

Sawadogo, S; Kafando, E; Nébié, K; Ouédraogo, A-S; Ouattara, S; Dahourou, H; Fretz, C; Deneys, V

2017-11-01

The National Blood Transfusion Centre, unique operator of blood transfusion in Burkina Faso is engaged into the quality process according to ISO 9001. Therefore, the assessment of customer satisfaction is a main part of its system. Our study conceives "customer satisfaction" as dependant to the perceived service quality based on SERVQUAL model. To identify factors associated with the satisfaction of blood products prescribers in order to help decision-makers for continuous improvement of services. We conducted a cross-sectional survey among prescribers of blood components in Ouagadougou, between February 27 and April 30, 2015. We used an anonymous self-administered questionnaire, including 13 items associated to the 5 dimensions of SERVQUAL model. The different satisfaction gaps were calculated and linear regression was used to determine statistical associations with a significance level of 5%. The return rate was 94.5% about the 256 questionnaires distributed. A total of 30% of respondents were satisfied to very satisfied. The overall global gap of satisfaction was -5.74. The product delivery time, the efficacy and safety of blood products, the medical and clinical support, the pro-activity of the communication, the management of blood products reservation and the satisfaction of needs in blood products were the factors associated with the prescribers' satisfaction. This first study in blood transfusion services in our context was been useful to assess customer satisfaction and identify the main axes on which targeting priority actions in order to effectively use available resources. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Application of Six Sigma/CAP methodology: controlling blood-product utilization and costs.

PubMed

Neri, Robert A; Mason, Cindy E; Demko, Lisa A

2008-01-01

Blood-product components are a limited commodity whose cost is rising. Many patients benefit from their use, but patients who receive transfusions face an unnecessary increased risk for developing infections; fatal, febrile, or allergic reactions; and circulatory overload. To improve patient care, safety, and resource stewardship, transfusion practices must be evaluated for appropriateness (Wilson et al. 2002). A multihospital health system undertook a rigorous study of blood-product utilization patterns and management processes to address cost-control problems in the organization. The system leveraged two process improvement tools widely implemented outside of the healthcare industry: (1) Six Sigma methodology to identify blood-utilization drivers and to standardize transfusion practice, and (2) change acceleration process model to drive effective change. The initiative resulted in a decreased rate of inappropriate transfusions of packed red blood cell from 16 percent to less than 5 percent, improved clinician use of a blood-component order form, establishment of internal benchmarks, enhanced laboratory-to-clinician communication, and better blood-product expense control. The project further demonstrated how out-of-industry tools and methodologies can be adopted, adapted, and systematically applied to generate positive change (Black and Revere 2006).

Mining consumer reviews to generate ratings of different product attributes while producing feature-based review-summary

NASA Astrophysics Data System (ADS)

Kangale, Akshay; Krishna Kumar, S.; Arshad Naeem, Mohd; Williams, Mark; Tiwari, M. K.

2016-10-01

With the massive growth of the internet, product reviews increasingly serve as an important source of information for customers to make choices online. Customers depend on these reviews to understand users' experience, and manufacturers rely on this user-generated content to capture user sentiments about their product. Therefore, it is in the best interest of both customers and manufacturers to have a portal where they can read a complete comprehensive summary of these reviews in minimum time. With this in mind, we arrived at our first objective which is to generate a feature-based review-summary. Our second objective is to develop a predictive model to know the next week's product sales based on numerical review ratings and textual features embedded in the reviews. When it comes to product features, every user has different priorities for different features. To capture this aspect of decision-making, we have designed a new mechanism to generate a numerical rating for every feature of the product individually. The data have been collected from a well-known commercial website for two different products. The validation of the model is carried out using a crowd-sourcing technique.

Effect of calcitriol on in vitro whole blood cytokine production in critically ill dogs.

PubMed

Jaffey, J A; Amorim, J; DeClue, A E

2018-06-01

Hypovitaminosis D has been identified as a predictor of mortality in human beings, dogs, cats and foals. However, the immunomodulatory effects of vitamin D in critically ill dogs has not been evaluated. The aim of this study was to evaluate the effect of calcitriol on cytokine production from whole blood collected from critically ill dogs in vitro. Twelve critically ill dogs admitted to a veterinary intensive care unit (ICU) were enrolled in a prospective cohort study. Whole blood from these dogs was incubated with calcitriol (2×10 -7 M) or ethanol (control) for 24h. Subsequent to this incubation, lipopolysaccharide (LPS)-stimulated whole blood production of tumor necrosis factor (TNF)-α, interleukin (IL)-6 and IL-10 were measured using a canine-specific multiplex assay. Calcitriol significantly increased LPS-stimulated whole blood production of IL-10 and decreased TNF-α production without significantly altering IL-6 production. There was no significant difference in whole blood cytokine production capacity between survivors and non-survivors at the time of discharge from the ICU or 30days after discharge. These data suggests that calcitriol induces an anti-inflammatory phenotype in vitro in whole blood from critically ill dogs. Copyright © 2018 Elsevier Ltd. All rights reserved.

Transfusions of blood products and cancer outcomes.

PubMed

Velásquez, J F; Cata, J P

2015-10-01

Approximately half of cancer patients scheduled for major surgery are anemic. Also, a significant number of patients will present to the operating room with low platelet counts and coagulopathic disorders. Unfortunately, administration of red blood cells, platelets concentrates and fresh-frozen plasma is associated with unwanted adverse effects including fever, hemolytic reactions and transfusion-related immunomodulation (TRIM). TRIM is a multifactorial immunologic phenomenon in the recipient mediated by donor leukocytes, microparticles such as ectosomes, and growth factors. As some of these molecules are secreted in a time-dependent manner, blood storage time may play an important in TRIM, although the evidence is limited. Perioperative administration of red blood cells and associated TRIM has also been associated with increased recurrence of certain solid tumors, such as colorectal, lung, and hepatobiliary tumors. In this continuing education article, we review the available evidence on how perioperative blood product transfusions can affect oncological outcomes, such as cancer recurrence. Copyright © 2014 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Patient safety with blood products administration using wireless and bar-code technology.

PubMed

Porcella, Aleta; Walker, Kristy

2005-01-01

Supported by a grant from the Agency for Healthcare Research and Quality, a University of Iowa Hospitals and Clinics interdisciplinary research team created an online data-capture-response tool utilizing wireless mobile devices and bar code technology to track and improve blood products administration process. The tool captures 1) sample collection, 2) sample arrival in the blood bank, 3) blood product dispense from blood bank, and 4) administration. At each step, the scanned patient wristband ID bar code is automatically compared to scanned identification barcode on requisition, sample, and/or product, and the system presents either a confirmation or an error message to the user. Following an eight-month, 5 unit, staged pilot, a 'big bang,' hospital-wide implementation occurred on February 7, 2005. Preliminary results from pilot data indicate that the new barcode process captures errors 3 to 10 times better than the old manual process.

Cytokine production by oral and peripheral blood neutrophils in adult periodontitis.

PubMed

Galbraith, G M; Hagan, C; Steed, R B; Sanders, J J; Javed, T

1997-09-01

Proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-alpha) and interleukin 1 beta (IL-1 beta) also possess bone-resorptive properties, and are generally considered to play a role in the pathogenesis of periodontal disease. In the present study, TNF-alpha and IL-1 beta production by oral and peripheral blood polymorphonuclear leukocytes (PMN) was examined in 40 patients with adult periodontitis and 40 orally healthy matched controls. Oral PMN released considerable amounts of both cytokines in unstimulated culture, and there was no difference between patients and controls when the cytokine levels were corrected for cell number. However, when the effect of disease activity was examined, cytokine release by oral PMN was found to be greatest in patients with advanced periodontitis. Within the healthy control group, IL-1 beta production by oral PMN was significantly higher in males (Mann-Whitney test, P = 0.0008). Examination of IL-1 beta production by peripheral blood PMN exposed to recombinant human granulocyte-macrophage colony stimulating factor revealed no difference between the patient and control groups. In contrast, IL-1 beta production by peripheral blood PMN was significantly reduced in patients with advanced disease (Mann-Whitney test, P = 0.02), and peripheral PMN IL-1 beta synthesis was greater in female controls (Mann-Whitney test, P = 0.054). No effect of race on cytokine production could be discerned in patients or controls. These results indicate that several factors influence cytokine production in oral health and disease, and that a dichotomy in cytokine gene expression exists between oral and peripheral blood PMN in adult periodontitis.

19 CFR 151.41 - Information on entry summary.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 2 2010-04-01 2010-04-01 false Information on entry summary. 151.41 Section 151... Products § 151.41 Information on entry summary. On the entry summary for petroleum or petroleum products in.... If the exact volumetric quantity cannot be determined in advance, the entry summary may be made for...

Clinical use of indium-111 labeled blood products

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

Loken, M.K.; Clay, M.E.; Carpenter, R.T.

1985-12-01

Following the introduction of In-111 oxine as a label for blood cells by McAffee and Thakur in 1976, these procedures have become increasingly important in the practice of nuclear medicine. Of particular interest are studies involving the use of labeled leukocytes for the detection of focal infection. The clinical utility of labeled platelets is less well developed, although the use of platelets to detect the formation of thrombi in blood vessels and on vascular grafts and prostheses is gaining prominence. This report summarizes the techniques presently employed at the University of Minnesota for the labeling of blood products, and theirmore » clinical use. Consideration also is given to the desired expertise and cost factors involved in the labeling of leukocytes and platelets.43 references.« less

Comparing two botulinum toxin type A formulations using manufacturers' product summaries.

PubMed

Wenzel, R; Jones, D; Borrego, J A

2007-08-01

Because of the unique pharmacology and clinical versatility of botulinum toxin (BoNT), particularly BoNT serotype A (BoNTA), a need exists for discussion of the current data on similarities and differences between two BoNTA products, BOTOX and Dysport. We compared the physiochemical and pharmacological properties of BOTOX and Dysport using information from the Summary of Product Characteristics (SmPC) documents from a number of countries around the world. Our analysis based on the SmPC documents demonstrated distinct differences in physical characteristics, breadth of approved indications, dosing and administration, and the incidence and severity of adverse events. BOTOX and Dysport are not bioequivalent. Many of the differences between BOTOX and Dysport discussed within are probably related to the differences in their physical characteristics.

NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHOD SUMMARIES FOR COLLECTION AND ANALYSIS OF METALS AND VOCS IN BLOOD AND URINE (CDC-COMPENDIUM)

EPA Science Inventory

This compendium includes method summaries provided by the Centers for Disease Control and Prevention/National Center for Environmental Health (CDC/NCEH) for collection and shipping of blood and urine samples for analysis of metals and volatile organic compounds (VOCs). It provide...

77 FR 7588 - Blood Products Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Blood Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION... Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, Contact 1- 301...

Characteristics and Outcomes of Blood Product Transfusion During Critical Care Transport.

PubMed

Mena-Munoz, Jorge; Srivastava, Udayan; Martin-Gill, Christian; Suffoletto, Brian; Callaway, Clifton W; Guyette, Francis X

2016-01-01

Civilian out-of-hospital transfusions have not been adequately studied. This study seeks to characterize patients receiving out-of-hospital blood product transfusion during critical care transport. We studied patients transported by a regional critical care air-medical service who received blood products during transport. This service carries two units of uncrossmatched packed Red Blood Cells (pRBCs) on every transport in addition to blood obtained from referring facilities. The pRBC are administered according to a protocol for the treatment of hemorrhagic shock or based on medical command physician order. Transfusion amount was categorized into three groups based on the volume transfused (<350 mL, 350-700 mL, >700 mL). The association between prehospital transfusion and in-hospital outcomes (mortality, subsequent blood transfusion and emergent surgery) was estimated using logistic regression models, controlling for age, first systolic blood pressure, first heart rate, Glasgow Coma Score, time of transfer, and length of hospital admission. Among the 1,440 critical care transports with transfusions examined, 81% were for medical patients, being gastrointestinal hemorrhage the most common indication (26%, CI 24-28%). pRBC transfusions were associated with emergent surgery (OR = 1.81, 95% CI = 1.31-2.52) and in-hospital transfusions (OR = 2.00, 95% CI = 1.46-2.76). Those with transfusions >700 mL were associated with emergent surgery (OR = 1.79, 95% CI = 1.10-2.92) and mortality (OR = 2.11; 95% CI = 1.21-3.69). In this sample, the majority of patients receiving blood products during air-medical transport were transfused for medic conditions; gastrointestinal hemorrhage was the most common chief complaint. The pRBC transfusions were associated with emergent surgery and in-hospital transfusion. Transfusions of >700 mL were associated with mortality.

21 CFR 607.7 - Establishment registration and product listing of blood banks and other firms manufacturing human...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products. 607.7 Section 607.7 Food and... manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and...

21 CFR 607.7 - Establishment registration and product listing of blood banks and other firms manufacturing human...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products. 607.7 Section 607.7 Food and... manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and...

Studies on the mechanism of endogenous pyrogen production. II. Role of cell products in the regulation of pyrogen release from blood leukocytes.

PubMed

Bodel, P

1974-09-01

Some characteristics of the process by which endogenous pyrogen (EP), the mediator of fever, is released from cells were examined by using human blood leukocytes incubated in vitro. Studies were designed to examine a possible role for leukocyte products, including EP, in the induction, augmentation, or suppression of pyrogen release by blood leukocytes. Products of stimulated leukocytes, including a partially purified preparation of EP, did not induce significant activation of nonstimulated cells. Also, no evidence was obtained that stimulated cell products either augment or inhibit pyrogen production by other stimulated cells. A feedback control of EP production was thus not observed. A crude preparation of EP, containing other products of activated cells, maintained its pyrogenicity when incubated at pH 7.4 but not at pH 5.0. These studies thus provide no support for hypothesized control mechanisms regulating production of EP by blood leukocytes. By contrast, local inactivation of EP at inflammatory sites may modify the amount of EP entering the blood, and hence fever.

Transfusion: -80°C Frozen Blood Products Are Safe and Effective in Military Casualty Care.

PubMed

Noorman, Femke; van Dongen, Thijs T C F; Plat, Marie-Christine J; Badloe, John F; Hess, John R; Hoencamp, Rigo

2016-01-01

The Netherlands Armed Forces use -80°C frozen red blood cells (RBCs), plasma and platelets combined with regular liquid stored RBCs, for the treatment of (military) casualties in Medical Treatment Facilities abroad. Our objective was to assess and compare the use of -80°C frozen blood products in combination with the different transfusion protocols and their effect on the outcome of trauma casualties. Hemovigilance and combat casualties data from Afghanistan 2006-2010 for 272 (military) trauma casualties with or without massive transfusions (MT: ≥6 RBC/24hr, N = 82 and non-MT: 1-5 RBC/24hr, N = 190) were analyzed retrospectively. In November 2007, a massive transfusion protocol (MTP; 4:3:1 RBC:Plasma:Platelets) for ATLS® class III/IV hemorrhage was introduced in military theatre. Blood product use, injury severity and mortality were assessed pre- and post-introduction of the MTP. Data were compared to civilian and military trauma studies to assess effectiveness of the frozen blood products and MTP. No ABO incompatible blood products were transfused and only 1 mild transfusion reaction was observed with 3,060 transfused products. In hospital mortality decreased post-MTP for MT patients from 44% to 14% (P = 0.005) and for non-MT patients from 12.7% to 5.9% (P = 0.139). Average 24-hour RBC, plasma and platelet ratios were comparable and accompanying 24-hour mortality rates were low compared to studies that used similar numbers of liquid stored (and on site donated) blood products. This report describes for the first time that the combination of -80°C frozen platelets, plasma and red cells is safe and at least as effective as standard blood products in the treatment of (military) trauma casualties. Frozen blood can save the lives of casualties of armed conflict without the need for in-theatre blood collection. These results may also contribute to solutions for logistic problems in civilian blood supply in remote areas.

Novel, high-yield red blood cell production methods from CD34-positive cells derived from human embryonic stem, yolk sac, fetal liver, cord blood, and peripheral blood.

PubMed

Olivier, Emmanuel; Qiu, Caihong; Bouhassira, Eric E

2012-08-01

The current supply of red blood cells expressing rare blood groups is not sufficient to cover all the existing transfusion needs for chronically transfused patients, such as sickle cell disease homozygous carriers, because of alloimmunization. In vitro production of cultured red blood cells is slowly emerging as a possible complement to the existing collection-based red blood cell procurement system. The yield of cultured red blood cells can theoretically be maximized by amplifying the stem, progenitor, or precursor compartment. Here, we combined methods designed to expand these three compartments to optimize the yield of cultured red blood cells and found that exposing CD34(+) cells to a short pulse of cytokines favorable for erythroid differentiation prior to stem cell expansion followed by progenitor expansion produced the highest yield of erythroid cells. This novel serum-free red blood cell production protocol was efficient on CD34(+) cells derived from human embryonic stem cells, 6-8-week yolk sacs, 16-18-week fetal livers, cord blood, and peripheral blood. The yields of cells obtained with these new protocols were larger by an order of magnitude than the yields observed previously. Globin expression analysis by high-performance liquid chromatography revealed that these expansion protocols generally yielded red blood cells that expressed a globin profile similar to that expected for the developmental age of the CD34(+) cells.

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

Red blood cell production

MedlinePlus Videos and Cool Tools

... body's tissues in exchange for carbon dioxide, which is carried to and eliminated by the lungs. Red blood cells are formed in the red bone marrow ... 2 days. The body makes about two million red blood cells every second. Blood is made up of both cellular and liquid components. ...

Studies on the Mechanism of Endogenous Pyrogen Production II. Role of Cell Products in the Regulation of Pyrogen Release from Blood Leukocytes

PubMed Central

Bodel, Phyllis

1974-01-01

Some characteristics of the process by which endogenous pyrogen (EP), the mediator of fever, is released from cells were examined by using human blood leukocytes incubated in vitro. Studies were designed to examine a possible role for leukocyte products, including EP, in the induction, augmentation, or suppression of pyrogen release by blood leukocytes. Products of stimulated leukocytes, including a partially purified preparation of EP, did not induce significant activation of nonstimulated cells. Also, no evidence was obtained that stimulated cell products either augment or inhibit pyrogen production by other stimulated cells. A feedback control of EP production was thus not observed. A crude preparation of EP, containing other products of activated cells, maintained its pyrogenicity when incubated at pH 7.4 but not at pH 5.0. These studies thus provide no support for hypothesized control mechanisms regulating production of EP by blood leukocytes. By contrast, local inactivation of EP at inflammatory sites may modify the amount of EP entering the blood, and hence fever. PMID:4426696

9 CFR 4.10 - Summary action.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Summary action. 4.10 Section 4.10 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL... Practice § 4.10 Summary action. (a) In any situation where the Administrator has reason to believe that any...

NHEXAS PHASE I MARYLAND STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHOD SUMMARIES FOR COLLECTION AND ANALYSIS OF METALS, PESTICIDE METABOLITES, AND VOCS IN BLOOD AND URINE (CDC-COMPENDIUM)

EPA Science Inventory

This compendium includes method summaries provided by the Centers for Disease Control and Prevention/National Center for Environmental Health (CDC/NCEH) for the collection and shipping of blood and urine samples for analysis of metals and volatile organic compounds (VOCs). It pro...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHOD SUMMARIES FOR COLLECTION AND ANALYSIS OF METALS, PESTICIDE METABOLITES, AND VOC IN BLOOD AND URINE (CDC-COMPENDIUM)

EPA Science Inventory

This compendium includes method summaries provided by the Centers for Disease Control and Prevention/National Center for Environmental Health (CDC/NCEH) for the collection and shipping of blood and urine samples for analysis of metals and volatile organic compounds (VOCs). It pro...

Clinical review: Canadian National Advisory Committee on Blood and Blood Products - Massive Transfusion Consensus Conference 2011: report of the panel

PubMed Central

2011-01-01

In June 2011 the Canadian National Advisory Committee on Blood and Blood Products sponsored an international consensus conference on transfusion and trauma. A panel of 10 experts and two external advisors reviewed the current medical literature and information presented at the conference by invited international speakers and attendees. The Consensus Panel addressed six specific questions on the topic of blood transfusion in trauma. The questions focused on: ratio-based blood resuscitation in trauma patients; the impact of survivorship bias in current research conclusions; the value of nonplasma coagulation products; the role of protocols for delivery of urgent transfusion; the merits of traditional laboratory monitoring compared with measures of clot viscoelasticity; and opportunities for future research. Key findings include a lack of evidence to support the use of 1:1:1 blood component ratios as the standard of care, the importance of early use of tranexamic acid, the expected value of an organized response plan, and the recommendation for an integrated approach that includes antifibrinolytics, rapid release of red blood cells, and a foundation ratio of blood components adjusted by results from either traditional coagulation tests or clot viscoelasticity or both. The present report is intended to provide guidance to practitioners, hospitals, and policy-makers. PMID:22188866

Blood derived products in pediatrics: New laboratory tools for optimizing potency assignment and reducing side effects.

PubMed

Amiral, Jean; Seghatchian, Jerard

2017-04-01

Neonates and children can develop rare bleeding disorders due to congenital/acquired coagulation Factor deficiencies, or allo-immune/autoimmune complications, or can undergo surgeries at high haemorrhagic risk. They then need specialized transfusion of blood components/products, or purified blood extracted products or recombinant proteins. Blood-derived therapies conventionally used for management of affected infants with genetic/acquired deficiencies, bleeding problems (coagulation Factor reduced or missing) or thrombotic disorders (reduced or missing anticoagulant proteins) pose some additional risks. These remedial therapies can cause tolerance when used very early in life and, sometimes needed, repeatedly. The introduction of recombinant proteins has allowed manufacturers to produce large amounts of the proteins usually present at very low concentration in blood. This has also changed the risk pattern of plasma-extracted products, especially in terms of continual reduction of viral transmission. Many efforts have been made over these past decades to reduce the risks associated with the use of all these products in terms of viral and bacterial safety, as well as immune disorders but they are not the objective of this article. Other associated side effects are the presence of undesired activities in blood products, which can produce thrombotic events or adverse reactions. The progressive introduction of blood derived products has greatly improved the prognosis and quality of life of affected patients. This concerns whole blood, but also blood cell concentrates, mainly platelets and red blood cells, plasma, while the blood extracted products are increasingly replaced by recombinant proteins. All these therapeutic products, i.e. blood extracted drugs, improve health and quality of life for hemophiliac's A or B, or patients with auto/allo-immune thrombocytopenias or with rare bleeding disorders, and those with thrombotic events occurring in childhood, which are

GATEWAY Report Brief: Evaluating OLED Lighting in the Accounting Office of DeJoy, Knauf & Blood LLP

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

None

Summary of GATEWAY report evaluating a new lighting system, at the offices of the accounting firm of DeJoy, Knauf & Blood, LLP in Rochester, NY, that incorporates a number of different OLED luminaires. Evaluation of the OLED products included efficacy performance, field measurements of panel color, flicker measurements, and staff feedback.

Apheresis product identification in the transplant center: development of point-of-care protocols for extended blood typing of stem cell apheresis products.

PubMed

Cummerow, C; Schwind, P; Spicher, M; Spohn, G; Geisen, C; Seifried, E; Bönig, H

2012-06-01

Transfusion of the 'wrong' stem cell product would almost inevitably be lethal, yet assays to confirm the contents of the product bag, except by checking labels and paperwork, are lacking. To increase the likelihood that a product mix-up would be detected in the transplant center, we developed a simple protocol for extended blood typing and hence, for confirmation of donor/product identity, on a tube segment. Apheresis samples were applied, directly or after erythrocyte enrichment, to commercially available blood typing assays, including lateral flow cards and gel agglutination cards. Without sample modification, low hematocrit and high leukocyte count obviated definitive blood typing. Using the most simple erythrocyte enrichment protocol, that is, centrifugation, reliable blood group analysis became possible with either assay. Other, more cumbersome pre-analytical protocols were also successful but provided no advantage. The preferred method was validated on 100 samples; ABD was correctly identified in 100% of cases. Of the other Rh Ags, all except two 'small e', in both cases in heterozygous individuals, were detected; there were no false positives. A simple, inexpensive point-of-care assay for extended blood typing of apheresis products is available, which can reduce the fatal risk of administering the wrong stem cell product.

Utilization of natural products for treatment of blood diseases.

PubMed

Miles, D H; Nguyen, C L; Miles, D H

1998-12-01

This chapter presents an introduction to several diseases of the blood including infectious mononucleosis, leukemia, thrombosis and coagulation, bone marrow disorders, malaria, and anemia. In addition a survey of the recent literature is presented relative to natural products that have been utilized for the treatment of these diseases. The natural products that are reported represent a wide range of structural types and present interesting mechanisms of action. Thus the possibility exists that new drugs may be developed from these natural products which are more effective than those currently on the market.

In vitro lysis and acute transfusion reactions with hemolysis caused by inappropriate storage of canine red blood cell products.

PubMed

Patterson, J; Rousseau, A; Kessler, R J; Giger, U

2011-01-01

Transfusion of red blood cell (RBC) products carries considerable risk for adverse reactions, including life-threatening hemolytic reactions. To report the occurrence and investigation of life-threatening acute transfusion reactions with hemolysis in dogs likely related to inappropriate blood product storage. Four dogs with acute transfusion reactions and other recipients of blood products. Medical records were reviewed from 4 dogs with suspected acute hemolytic transfusion reactions after receiving RBC products at a veterinary clinic over a 1-month period. Medical records of other animals receiving blood products in the same time period also were reviewed. Blood compatibility and product quality were assessed, subsequent transfusions were closely monitored, and products were diligently audited. During or immediately after RBC product transfusion, 4 dogs developed hemolysis, hemoglobinuria, or both. Two dogs died and 1 was euthanized because of progressive clinical signs compatible with an acute hemolytic transfusion reaction. Blood type and blood compatibility were confirmed. RBC units from 2 blood banks were found to be hemolyzed after storage in the clinic's refrigerator; no bacterial contamination was identified. After obtaining a new refrigerator dedicated to blood product storage, the problem of hemolyzed units and acute transfusion reactions with hemolysis completely resolved. Acute life-threatening transfusion reactions can be caused by inappropriate storage of RBC products. In addition to infectious disease screening and ensuring blood-type compatibility, quality assessment of blood products, appropriate collection, processing, and storage techniques as well as recipient monitoring are critical to provide safe, effective transfusions. Copyright © 2011 by the American College of Veterinary Internal Medicine.

[Promising technologies of packed red blood cells production and storage].

PubMed

Maksimov, A G; Golota, A S; Krassiĭ, A B

2013-10-01

The current article is dedicated to promising technologies of packed red blood cells production and storage. The following new technical approaches are presented: (1) erythrocytes storage in strict anaerobic argon-hydrogen environment, (2) lyophilization of erythrocyte suspension by its atomization in nitrogen gas, (3) lyophilization of erythrocytes by directional freezing under the influence of radio frequency radiation, (4) automated pharming of antigen free packed red blood cells from progenitor cell directly at the battlefield.

Spine tumor resection among patients who refuse blood product transfusion: a retrospective case series.

PubMed

Kisilevsky, Alexandra E; Stobart, Liam; Roland, Kristine; Flexman, Alana M

2016-12-01

To describe the perioperative blood conservation strategies and postoperative outcomes in patients who undergo complex spinal surgery for tumor resection and who also refuse blood product transfusion. A retrospective case series. A single-center, tertiary care and academic teaching hospital in Canada. All adult patients undergoing elective major spine tumor resection and refusing blood product transfusion who were referred to our institutional Blood Utilization Program between June 1, 2004, and May 9, 2014. Data on the use of iron, erythropoietin, preoperative autologous blood donation, acute normovolemic hemodilution, antifibrinolytic therapy, cell salvage, intraoperative hypotension, and active warming techniques were collected. Data on perioperative hemoglobin nadir, adverse outcomes, and hospital length of stay were also collected. Four patients who refused blood transfusion (self-identified as Jehovah's Witnesses) underwent non-emergent complex spine surgery for recurrent chondrosarcoma, meningioma, metastatic adenocarcinoma, and metastatic malignant melanoma. All patients received 1 or more perioperative blood conservation strategy including preoperative iron and/or erythropoietin, intraoperative antifibrinolytic therapy, and cell salvage. No patients experienced severe perioperative anemia (average hemoglobin nadir, 124 g/L) or anemia-related postoperative complications. Patients who decline blood product transfusion can successfully undergo major spine tumor resection. Careful patient selection and timely referral for perioperative optimization such that the risk of severe anemia is minimized are important for success. Copyright © 2016 Elsevier Inc. All rights reserved.

Guidelines on product liability for the hospital blood bank. The British Committee for Standards in Haematology.

PubMed

1990-01-01

This report aims to clarify the position of the hospital blood bank in the light of product liability legislation contained in the Consumer Protection Act of 1987. Blood has been defined a 'product' under this Act. The potential for the blood bank to be seen in the role of 'supplier', 'keeper' or even 'producer' in the chain of product supply to the patient is explained and advice given on the resulting implications for blood bank practice. It will be necessary to define, adopt and implement standard operating procedures (SOP) for all blood bank activities. Guidance is given on the format, preparation and content of SOPs and specimen examples offered. The fundamental importance of quality assurance is emphasized.

Army Air Ambulance Blood Product Program in the Combat Zone and Challenges to Best Practices.

PubMed

Powell-Dunford, Nicole; Quesada, Jose F; Gross, Kirby R; Shackelford, Stacy A

2016-08-01

Identify challenges and best practices in the development of an austere air ambulance transfusion program. A search of PubMed using combinations of the key terms 'prehospital,' 'blood product,' 'red blood cells,' 'damage control resuscitation,' 'transfusion,' 'air ambulance,' 'medical evacuation,' and 'medevac' yielded 196 articles for further analysis, with 14 articles suitable for addressing the background of prehospital transfusion within a helicopter. Retrospective analysis of unclassified briefs, after action reports, and procedures was also undertaken along with interview of subject matter experts. The initial series of 15 transfusions were discussed telephonically among flight crew, trauma surgeons, and lab specialists. Review of Joint Theater System data was readily available for 84 U.S. Army air ambulance transfusions between May-December 2012, with December marking the redeployment of the 25(th) Combat Aviation Brigade. Standardized implementation enabled safe blood product administration for 84 causalities from May-December 2012 without blood product shortage, expiration, or transfusion reaction. Challenges included developing transfusion competency, achieving high quality blood support, countering the potential for anti-U.S. sentiment, and diversity in coalition transfusion practices. Blood product administration aboard the air ambulance is logistically complex, requiring blood bank integration. Repetitive training enabled emergency medical technicians (EMTs) with basic medical training to safely perform transfusion in accordance with clinical operating guidelines. In the austere environment, logistic factors are significant challenges and political sensitivities are important considerations. Best practices may facilitate new en route transfusion programs. Powell-Dunford N, Quesada JF, Gross KR, Shackelford SA. Army air ambulance blood product program in the combat zone and challenges to best practices. Aerosp Med Hum Perform. 2016; 87(8):728-734.

The manufacture of blood plasma products in Scotland: a brief history.

PubMed

Foster, Peter R

2016-02-01

A number of essential clinical products are derived from human blood plasma, including immunoglobulin products for the treatment of infections and disorders of immunity; albumin for protein and fluid replacement and coagulation factors for the treatment of haemophilia and other disorders of haemostasis. For many years, these protein pharmaceuticals were manufactured by the Scottish National Blood Transfusion Service (SNBTS) at its Scottish Protein Fractionation Centre (PFC) in Edinburgh, a contribution which ended with the closure of the PFC in 2008. The origins and development of plasma fractionation in Scotland are summarised in this article, as well as issues which contributed to the closure of the PFC. © The Author(s) 2015.

Red blood cells, still vital after all these years: Commentary on Canadian Blood Services' International Symposium 2017.

PubMed

Qadri, Syed M; Donkor, David A; Yan, Matthew; Ning, Shuoyan; Branch, Donald R; Seghatchian, Jerard; Sheffield, William P

2018-04-01

Canadian Blood Services (CBS), Canada's national blood transfusion service, has for many years sponsored an annual conference, for the education and awareness of interested participants, showcasing the latest evidence-based understanding of both basic science and clinical issues in transfusion medicine and science. The 15th iteration of this symposium took place September 9, 2017 and focused on some of the vital aspects of red blood cells (RBC), in line with the" 3Rs" concept, namely the provision of the Right red blood cell (RBC) product to the Right patient at the Right time. Presentations touched upon: the evolution of blood banking in North America; the monocyte monolayer assay as a predictor of post-transfusion hemolysis; hemoglobin-based oxygen carriers; RBC alloimmunization; serological approaches to complex RBC antibody problems; randomized clinical trials related to the age of stored RBC; RBC genotyping; pathophysiology, prevention and treatment of hemolytic disease of the fetus and newborn (HDFN); and testing and timing in perinatal serology. This commentary provides summaries of all speakers' presentations annotated with relevant references. Special thanks are due to all contributors for their praiseworthy approaches in sharing their experiences and knowledge on this interesting scientific/clinical and management theme. Copyright © 2018 Elsevier Ltd. All rights reserved.

Blood Levels of Zinc in Creole Horses Used in Sera Production

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

Baptista, Tatyana S.; Instituto Butantan, Av Vital Brasil 1500 05503-900 Sao Paulo, SP; Zamboni, Cibele B.

2010-08-04

Using Neutron Activation Analysis Zn concentrations were determined in blood of horses (Creole breed). No significant difference was observed between male (0.0029{+-}.0007 gL{sup -1}) and female (0.0031{+-}.0011 gL{sup -1}) animals. These data are an important support to understand the physiological functions of Zn in blood during the process of sera production at Butantan Institute (Sao Paulo, Brazil) using horses.

THE EFFECTS OF EXPERIMENTAL PLETHORA ON BLOOD PRODUCTION.

PubMed

Robertson, O H

1917-08-01

With the purpose of determining whether a diminished activity of the bone marrow could be brought about experimentally, plethora was produced in rabbits by means of repeated small transfusions of blood. Counts of the number of reticulated red cells in the circulating blood were made during the course of the experiments as an index to changes in the activity of the bone marrow. With the development of plethora, the number of reticulated cells in the blood decreased. In the majority of the plethoric animals, this diminution was extreme, and in some instances, reticulated cells practically disappeared from the blood. A comparison of the red bone marrow of these animals with that of normal controls revealed a marked reduction in the content of reticulated cells. After a number of transfusions, there occurred in some of the plethoric rabbits a sudden and marked drop in hemoglobin. The hemoglobin continued to fall until a severe grade of anemia was reached. This was followed by an extremely rapid regeneration accompanied by a striking rise in color index. During regeneration, the reticulated cells were enormously increased in number. Taken together, these facts show that the bone marrow is markedly influenced by plethora. The diminished number of reticulated cells observed, both in the circulating blood and in the marrow, would make it appear that a decided decrease in blood production occurs. The reduction in the number of these cells cannot be due to changes in the constitution of the red cells put out by the bone marrow, as a result of an increased quantity of hemoglobin in the body, because during regeneration from the above mentioned anemia, when the color index was very high, reticulated cells were still present in large numbers. That the activity of the bone marrow does actually diminish during plethora is further evidenced by the occurrence of the anemia. The most reasonable explanation of this phenomenon is that the recipient develops an immunity against the

Whole Blood Activation Results in Altered T Cell and Monocyte Cytokine Production Profiles by Flow Cytometry

NASA Technical Reports Server (NTRS)

Crucian, Brian E.; Sams, Clarence F.

2001-01-01

An excellent monitor of the immune balance of peripheral circulating cells is to determine their cytokine production patterns in response to stimuli. Using flow cytometry, a positive identification of cytokine producing cells in a mixed culture may be achieved. Recently, the ability to assess cytokine production following a whole-blood activation culture has been described. In this study, whole blood activation was compared to traditional PBMC activation and the individual cytokine secretion patterns for both T cells, T cell subsets and monocytes was determined by flow cytometry. RESULTS: For T cell cytokine assessment (IFNg/IL-10 and IL-21/L-4) following PMA +ionomycin activation: (1) a Significantly greater percentages of T cells producing IFNgamma and IL-2 were observed following whole-blood culture and (2) altered T cell cytokine production kinetics were observed by varying whole blood culture times. Four-color analysiS was used to allow assessment of cytokine production by specific T cell subsets. It was found that IFNgamma production was significantly elevated in the CD3+/CD8+ T cell population as compared to the CD3+/CD8- population following five hours of whole blood activation. Conversely, IL-2 and IL-10 production were Significantly elevated in the CD3+/CD8- T cell population as compared to the CD3+/CD8+ population. Monocyte cytokine production was assessed in both culture systems following LPS activation for 24 hours. A three-color flow cytometric was used to assess two cytokines (IL-1a/IL-12 and TNFa/IL-10) in conjunction with CD14. Nearly all monocytes were stimulated to produce IL-1a, IL-12 and TNFa. equally well in both culture systems, however monocyte production of IL-10 was significantly elevated in whole blood culture as compared to PBMC culture. IL-12 producing monocytes appeared to be a distinct subpopulation of the IL-1a producing set, whereas IL-10 and TNFa producing monocytes were largely mutually exclusive. IL-10 and TNFa producing

Storage duration and white blood cell content of red blood cell (RBC) products increases adhesion of stored RBCs to endothelium under flow conditions.

PubMed

Anniss, Angela M; Sparrow, Rosemary L

2006-09-01

Adherence of red blood cells (RBCs) to vascular endothelium impairs blood flow and decreases oxygen delivery. Although RBCs may be stored for up to 42 days before transfusion under current blood banking guidelines, little is known of how changes to RBCs during storage may affect their adherence properties. The influence of RBC product storage time and white blood cell (WBC) burden on the adherence of RBCs for transfusion to vascular endothelium under conditions of continuous flow was investigated in this study. RBC samples were collected from nonleukoreduced (S-RBC), buffy coat-poor (BCP-RBC), and leukofiltered (LF-RBC) products at fixed time points during storage. Samples were perfused, at controlled shear stress and temperature, across a confluent endothelial cell (EC) monolayer with a parallel-flow chamber mounted to an inverted microscope. RBC-EC interactions were recorded with a digital camera attached to the microscope. The number of RBCs adhering to the EC layer increased significantly with storage time in all RBC products; however, WBC reduction delayed this increase. LF-RBCs were also significantly less adherent than S-RBC or BCP-RBC products on Day 1 of storage (p < 0.05). The strength of RBC attachment to vascular endothelium was significantly stronger in S-RBC products compared to BCP-RBC and LF-RBC products. Our findings indicate that product storage time and WBC burden increase the number and strength of adhesion of RBCs to vascular endothelium. These results may lead to greater understanding of the interaction of transfused RBCs with recipient endothelium and the biologic consequences of this adherence.

Postoperative acute kidney injury following intraoperative blood product transfusions during cardiac surgery.

PubMed

Kindzelski, Bogdan A; Corcoran, Philip; Siegenthaler, Michael P; Horvath, Keith A

2018-01-01

This study explored the nature of the association between intraoperative usage of red blood cell, fresh frozen plasma, cryoprecipitate or platelet transfusions and acute kidney injury. A total of 1175 patients who underwent cardiac surgery between 2008 and 2013 were retrospectively analyzed. We assessed the association between: (1) preoperative patient characteristics and acute kidney injury, (2) intraoperative blood product usage and acute kidney injury, (3) acute kidney injury and 30-day mortality or re-hospitalization. In our cohort of 1175 patients, 288 patients (24.5%) developed acute kidney injury. This included 162 (13.8%), 69 (5.9%) and 57 (4.9%) developing stage 1, stage 2 or stage 3 acute kidney injury, respectively. Increased red blood cell, fresh frozen plasma or platelet transfusions increased the odds of developing acute kidney injury. Specifically, every unit of red blood cells, fresh frozen plasma or platelets transfused was associated with an increase in the covariate-adjusted odds ratio of developing ⩾ stage 2 kidney injury of 1.18, 1.19 and 1.04, respectively. Intraoperative blood product transfusions were independently associated with an increased odds of developing acute kidney injury following cardiac surgery. Further randomized studies are needed to better define intraoperative transfusion criteria.

Relevancy of Serum Calcium in Predicting Blood Product Transfusion in Trauma

DTIC Science & Technology

2017-08-10

reduction. Most pre-hospital or field medical criteria used to predict blood product needs in trauma patients rely on a combination of physiological ...This effect was age specific for the subject group aged 40 years and below. Patients with normal blood pressure could give medical teams a false...transfusion, as well as transfusion of more than four units within 4 hours, even after controlling for other clinical variables. This effect was age

Effects of dorzolamide on choroidal blood flow, ciliary blood flow, and aqueous production in rabbits.

PubMed

Reitsamer, Herbert A; Bogner, Barbara; Tockner, Birgit; Kiel, Jeffrey W

2009-05-01

To determine the effects of topical dorzolamide (a carbonic anhydrase inhibitor) on choroidal and ciliary blood flow and the relationship between ciliary blood flow and aqueous flow. The experiments were performed in four groups of pentobarbital-anesthetized rabbits treated with topical dorzolamide (2%, 50 microL). In all groups, intraocular pressure (IOP) and mean arterial pressure (MAP) at the eye level were measured continuously by direct cannulation. In group 1, aqueous flow was measured by fluorophotometry before and after dorzolamide treatment. In group 2, aqueous flow was measured after dorzolamide at normal MAP and while MAP was held constant at 80, 55, or 40 mm Hg with occluders on the aorta and vena cava. In group 3, the same MAP levels were used, and ciliary blood flow was measured transsclerally by laser Doppler flowmetry (LDF). In group 4, choroidal blood flow was measured by LDF with the probe tip positioned in the vitreous over the posterior pole during ramp increases and decreases in MAP before and after dorzolamide. Dorzolamide lowered IOP by 19% (P < 0.01) and aqueous flow by 17% (P < 0.01), and increased ciliary blood flow by 18% (P < 0.01), which was associated with a significant reduction in ciliary vasculature resistance (-7%, P < 0.01). Dorzolamide shifted the relationship between ciliary blood flow and aqueous flow downward relative to the previously determined control relationship in the rabbit. Dorzolamide did not alter choroidal blood flow, choroidal vascular resistance, or the choroidal pressure flow relationship. Acute topical dorzolamide is a ciliary vasodilator and has a direct inhibitory effect on aqueous production, but it does not have a detectable effect on choroidal hemodynamics at the posterior pole in the rabbit.

Pricing behavior of non-profit agencies. The case of blood products.

PubMed

Jacobs, P; Wilder, R P

1984-04-01

In this study we examine the pricing behavior of a non-profit agency, the American National Red Cross blood service units. Two alternative hypotheses are presented: one in which the agency maximizes profits,, and one in which output is maximized subject to a breakeven constraint. Following a general approach developed by Eckstein and Fromm , pricing equations for separate blood products are applied to cross-sectional data from Red Cross blood centers to determine the impact of demand, cost, competition, and subsidy variables. The impact of these variables, in particular the impact of the fixed subsidy on price, is shown to be consistent with the output-maximizing model.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHOD SUMMARIES FOR COLLECTION AND ANALYSIS OF METALS, PESTICIDE METABOLITES, AND VOC IN BLOOD AND URINE (CDC-COMPENDIUM)

EPA Science Inventory

This compendium includes method summaries provided by the Centers for Disease Control and Prevention/National Center for Environmental Health (CDC/NCEH) for the collection and shipping of blood and urine samples for analysis of metals and volatile organic compounds (VOCs). The pr...

Rational and timely haemostatic interventions following cardiac surgery - coagulation factor concentrates or blood bank products.

PubMed

Tang, Mariann; Fenger-Eriksen, Christian; Wierup, Per; Greisen, Jacob; Ingerslev, Jørgen; Hjortdal, Vibeke; Sørensen, Benny

2017-06-01

Cardiac surgery may cause a serious coagulopathy leading to increased risk of bleeding and transfusion demands. Blood bank products are commonly first line haemostatic intervention, but has been associated with hazardous side effect. Coagulation factor concentrates may be a more efficient, predictable, and potentially a safer treatment, although prospective clinical trials are needed to further explore these hypotheses. This study investigated the haemostatic potential of ex vivo supplementation of coagulation factor concentrates versus blood bank products on blood samples drawn from patients undergoing cardiac surgery. 30 adults were prospectively enrolled (mean age=63.9, females=27%). Ex vivo haemostatic interventions (monotherapy or combinations) were performed in whole blood taken immediately after surgery and two hours postoperatively. Fresh-frozen plasma, platelets, cryoprecipitate, fibrinogen concentrate, prothrombin complex concentrate (PCC), and recombinant FVIIa (rFVIIa) were investigated. The haemostatic effect was evaluated using whole blood thromboelastometry parameters, as well as by thrombin generation. Immediately after surgery the compromised maximum clot firmness was corrected by monotherapy with fibrinogen or platelets or combination therapy with fibrinogen. At two hours postoperatively the coagulation profile was further deranged as illustrated by a prolonged clotting time, a reduced maximum velocity and further diminished maximum clot firmness. The thrombin lagtime was progressively prolonged and both peak thrombin and endogenous thrombin potential were compromised. No monotherapy effectively corrected all haemostatic abnormalities. The most effective combinations were: fibrinogen+rFVIIa or fibrinogen+PCC. Blood bank products were not as effective in the correction of the coagulopathy. Coagulation factor concentrates appear to provide a more optimal haemostasis profile following cardiac surgery compared to blood bank products. Copyright © 2017

Implementation of a transfusion algorithm to reduce blood product utilization in pediatric cardiac surgery.

PubMed

Whitney, Gina; Daves, Suanne; Hughes, Alex; Watkins, Scott; Woods, Marcella; Kreger, Michael; Marincola, Paula; Chocron, Isaac; Donahue, Brian

2013-07-01

The goal of this project is to measure the impact of standardization of transfusion practice on blood product utilization and postoperative bleeding in pediatric cardiac surgery patients. Transfusion is common following cardiopulmonary bypass (CPB) in children and is associated with increased mortality, infection, and duration of mechanical ventilation. Transfusion in pediatric cardiac surgery is often based on clinical judgment rather than objective data. Although objective transfusion algorithms have demonstrated efficacy for reducing transfusion in adult cardiac surgery, such algorithms have not been applied in the pediatric setting. This quality improvement effort was designed to reduce blood product utilization in pediatric cardiac surgery using a blood product transfusion algorithm. We implemented an evidence-based transfusion protocol in January 2011 and monitored the impact of this algorithm on blood product utilization, chest tube output during the first 12 h of intensive care unit (ICU) admission, and predischarge mortality. When compared with the 12 months preceding implementation, blood utilization per case in the operating room odds ratio (OR) for the 11 months following implementation decreased by 66% for red cells (P = 0.001) and 86% for cryoprecipitate (P < 0.001). Blood utilization during the first 12 h of ICU did not increase during this time and actually decreased 56% for plasma (P = 0.006) and 41% for red cells (P = 0.031), indicating that the decrease in OR transfusion did not shift the transfusion burden to the ICU. Postoperative bleeding, as measured by chest tube output in the first 12 ICU hours, did not increase following implementation of the algorithm. Monthly surgical volume did not change significantly following implementation of the algorithm (P = 0.477). In a logistic regression model for predischarge mortality among the nontransplant patients, after accounting for surgical severity and duration of CPB, use of the transfusion

77 FR 45638 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

Multicomponent exercise decreases blood pressure, heart rate and double product in normotensive and hypertensive older patients with high blood pressure.

PubMed

Coelho-Júnior, Hélio José; Asano, Ricardo Yukio; Gonçalvez, Ivan de Oliveira; Brietzke, Cayque; Pires, Flávio Oliveira; Aguiar, Samuel da Silva; Feriani, Daniele Jardim; Caperuto, Erico Chagas; Uchida, Marco Carlos; Rodrigues, Bruno

2018-02-26

The present study aimed to investigate the effects of a 6-month multicomponent exercise program on blood pressure, heart rate, and double product of uncontrolled and controlled normotensive and hypertensive older patients. The study included 183 subjects, 97 normotensives, of which 53 were controlled normotensives (CNS), and 44 uncontrolled normotensives (UNS), as well as 86 hypertensives, of which 43 were controlled hypertensives (CHS), and 43 uncontrolled hypertensives (UHS). Volunteers were recruited and blood pressure and heart rate measurements were made before and after a 6-month multicomponent exercise program. The program of physical exercise was performed twice a week for 26 weeks. The physical exercises program was based on functional and walking exercises. Exercise sessions were performed at moderate intensity. The results indicated that UHS showed a marked decrease in systolic (-8.0mmHg), diastolic (-11.1mmHg), mean (-10.1mmHg), and pulse pressures, heart rate (-6.8bpm), and double product (-1640bpmmmHg), when compared to baseline. Similarly, diastolic (-5.5mmHg) and mean arterial (-4.8mmHg) pressures were significantly decreased in UNS. Concomitantly, significant changes could be observed in the body mass index (-0.9kg/m 2 ; -1.5kg/m 2 ) and waist circumference (-3.3cm; only UHS) of UNS and UHS, which may be associated with the changes observed in blood pressure. In conclusion, the data of the present study indicate that a 6-month multicomponent exercise program may lead to significant reductions in blood pressure, heart rate, and double product of normotensive and hypertensive patients with high blood pressure values. Copyright © 2018 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

49 CFR 1313.2 - Contract summary filing requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Contract summary filing requirement. 1313.2... FOR THE TRANSPORTATION OF AGRICULTURAL PRODUCTS § 1313.2 Contract summary filing requirement. (a) Rail... promptly file with the Board a summary of each contract entered into for the transportation of agricultural...

21 CFR 607.37 - Inspection of establishment registrations and blood product listings.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Inspection of establishment registrations and blood product listings. 607.37 Section 607.37 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... product listings should be directed to the Department of Health and Human Services, Food and Drug...

Ebola virus convalescent blood products: where we are now and where we may need to go.

PubMed

Burnouf, Thierry; Seghatchian, Jerard

2014-10-01

The world is regularly exposed to emerging infections with the potential to burst into a pandemic. One possible way to treat patients, when no other treatment is yet developed,is passive immunization performed by transfusing blood, plasma or plasma immunoglobul infractions obtained from convalescent donors who have recovered from the disease and have developed protective antibodies. The most recent on-going epidemic is caused by the Ebola virus, a filovirus responsible for Ebola virus disease, a severe, often lethal, hemorrhagic fever. Recently, the use of convalescent blood products was proposed by the WHO as one early option for treating patients with Ebola virus disease. This publication provides an overview of the various convalescent blood products and technological options that could theoretically be considered when there is a need to rely on this therapeutic approach.In countries without access to advanced blood-processing technologies, the choice may initially be restricted to convalescent whole blood or plasma. In technologically advanced countries, additional options for convalescent blood products are available, including virally inactivated plasma and fractionated immunoglobulins. The preparation of minipool immunoglobulins is also a realistic option to consider.

Effect of patient age on blood product transfusion after cardiac surgery.

PubMed

Ad, Niv; Massimiano, Paul S; Burton, Nelson A; Halpin, Linda; Pritchard, Graciela; Shuman, Deborah J; Holmes, Sari D

2015-07-01

Blood product transfusion after cardiac surgery is associated with increased morbidity and mortality. Transfusion thresholds are often lower for the elderly, despite the lack of clinical evidence for this practice. This study examined the role of age as a predictor for blood transfusion. A total of 1898 patients were identified who had nonemergent cardiac surgery, between January 2007 and August 2013, without intra-aortic balloon pumps or reoperations, and with short (<24 hours) intensive care unit stays (age ≥75 years; n = 239). Patients age ≥75 years were propensity-score matched to those age <75 years to balance covariates, resulting in 222 patients per group. Analyses of the matched sample examined age as a continuous variable, scaled in 5-year increments. After matching, covariates were balanced between older and younger patients. Older age significantly predicted postoperative (odds ratio = 1.39, P = .028), but not intraoperative (odds ratio = 0.96, P = .559), blood transfusion. Older age predicted longer length of stay (B = 0.21, P < .001), even after adjustment for blood product transfusion (B = 0.20, P < .001). As expected, older age was a significant predictor for poorer survival, even with multivariate adjustment (hazard ratio = 1.34, P = .042). In patients with a routine postoperative course, older age was associated with more postoperative blood transfusion. Older age was also predictive of longer length of stay and poorer survival, even after accounting for clinical factors. Continued study into effects of transfusion, particularly in the elderly, should be directed toward hospital transfusion protocols to optimize perioperative care. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

The effect of retrograde autologous priming on intraoperative blood product transfusion in coronary artery bypass grafting.

PubMed

Nanjappa, A; Gill, J; Sadat, U; Colah, S; Abu-Omar, Y; Nair, S

2013-11-01

Retrograde autologous priming (RAP) of the cardiopulmonary bypass (CPB) circuit could reduce the degree of haemodilution associated with priming with acellular solutions. However, there is no strong evidence to prove that the practice of RAP reduced intraoperative packed red cell (PRC) or blood product transfusion. To evaluate the effect of RAP on intraoperative PRC usage in coronary artery bypass grafting (CABG). This study is a prospective, observational study on patients who underwent first-time, isolated CABG using CPB between April 2012 and July 2012. Two groups of patients were identified: 1. Non-RAP group (n=128) and 2. RAP group (n=73). The primary outcome for the study was the amount of PRC and blood product usage between the induction of anaesthesia and the cessation of CPB. Use of PRC and blood products in the operating room was comparable in both groups. Univariate logistic regression showed that RAP was not an independent predictor of PRC or blood product transfusion (p=0.43). Multivariate logistic regression showed that CPB time, preoperative haemoglobin (Hb) levels and creatinine clearance were independent predictors of blood product transfusion. Practising RAP with mean volumes of 300 ml does not necessarily reduce PRC and other blood product transfusion requirements during CABG. In our practice, RAP was performed, aiming at displacing CPB circuit prime volume with which the perfusionist felt comfortable and dictated by haemodynamic parameters prior to commencing CPB. We presume this is the case in many units around the world. This practice, in our opinion, is not enough to achieve the benefits of RAP, if any, in the form of a reduction of packed red cell transfusion requirements. The true advantages of RAP in cardiac surgery need to be studied in a prospective, randomized, controlled trial.

The productivity limit of manufacturing blood cell therapy in scalable stirred bioreactors

PubMed Central

Bayley, Rachel; Ahmed, Forhad; Glen, Katie; McCall, Mark; Stacey, Adrian

2017-01-01

Abstract Manufacture of red blood cells (RBCs) from progenitors has been proposed as a method to reduce reliance on donors. Such a process would need to be extremely efficient for economic viability given a relatively low value product and high (2 × 1012) cell dose. Therefore, the aim of these studies was to define the productivity of an industry standard stirred‐tank bioreactor and determine engineering limitations of commercial red blood cells production. Cord blood derived CD34+ cells were cultured under erythroid differentiation conditions in a stirred micro‐bioreactor (Ambr™). Enucleated cells of 80% purity could be created under optimal physical conditions: pH 7.5, 50% oxygen, without gas‐sparging (which damaged cells) and with mechanical agitation (which directly increased enucleation). O2 consumption was low (~5 × 10–8 μg/cell.h) theoretically enabling erythroblast densities in excess of 5 × 108/ml in commercial bioreactors and sub‐10 l/unit production volumes. The bioreactor process achieved a 24% and 42% reduction in media volume and culture time, respectively, relative to unoptimized flask processing. However, media exchange limited productivity to 1 unit of erythroblasts per 500 l of media. Systematic replacement of media constituents, as well as screening for inhibitory levels of ammonia, lactate and key cytokines did not identify a reason for this limitation. We conclude that the properties of erythroblasts are such that the conventional constraints on cell manufacturing efficiency, such as mass transfer and metabolic demand, should not prevent high intensity production; furthermore, this could be achieved in industry standard equipment. However, identification and removal of an inhibitory mediator is required to enable these economies to be realized. Copyright © 2016 The Authors Journal of Tissue Engineering and Regenerative Medicine Published by John Wiley & Sons Ltd. PMID:27696710

Increased blood product use among coronary artery bypass patients prescribed preoperative aspirin and clopidogrel

PubMed Central

Ray, Joel G; Deniz, Stacy; Olivieri, Anthony; Pollex, Erika; Vermeulen, Marian J; Alexander, Kurian S; Cain, David J; Cybulsky, Irene; Hamielec, Cindy M

2003-01-01

Background The administration of antiplatelet drugs before coronary artery bypass graft surgery (CABG) is associated with an increased risk of major hemorrhage and related surgical reexploration. Little is known about the relative effect of combined clopidogrel and aspirin on blood product use around the time of CABG. We evaluated the associated risk between the combined use of aspirin and clopidogrel and the transfusion of blood products perioperatively. Methods We retrospectively studied a cohort of 659 individuals who underwent a first CABG, without concomitant valvular or aortic surgery, at a single large Canadian cardiac surgical centre between January 2000 and April 2002. The four study exposure groups were those prescribed aspirin (n = 105), clopidogrel (n = 11), the combination of both (n = 46), or neither drug (n = 497), within 7 days prior to CABG. The primary study outcome was the excessive transfusion of blood products during CABG and up to the second post-operative day, defined as ≥ 2 units of packed red blood cells (PRBC), ≥ 2 units of fresh frozen plasma, ≥ 5 units of cryoprecipitate or ≥ 5 units of platelets. Secondary outcomes included the mean number of transfused units of each type of blood product. Results A greater mean number of units of PRBC were transfused among those who received clopidogrel alone (2.9) or in combination with aspirin (2.4), compared to those on aspirin alone (1.9) or neither antiplatelet drug (1.4) (P = 0.001). A similar trend was seen for the respective mean number of transfused units of platelets (3.6, 3.7, 1.3 and 1.0; P < 0.001) and fresh frozen plasma (2.5, 3.1, 2.3, 1.6; P = 0.01). Compared to non-users, the associated risk of excessive blood product transfusion was highest among recipients of aspirin and clopidogrel together (adjusted OR 2.2, 95% CI 1.1–4.3). No significant association was seen among lone users of aspirin (adjusted OR 1.0, 95% CI 0.6–1.6) or clopidogrel (adjusted OR 0.7, 95% CI 0.2–2

BLOOD PRODUCT TRANSFUSIONS IN GREAT APES: A RETROSPECTIVE REVIEW OF 12 CASES.

PubMed

Hahn, Alicia; Sturgeon, Ginger; Rossi, Joseph

2017-06-01

Although the administration of blood and blood products can be lifesaving, transfusions in exotic species are less common because of the lack of knowledge of a species' blood groups, the availability of species-specific donors, and possible adverse effects. Recently, blood groups were elucidated in great apes; however, few reports have been published regarding actual transfusion situations in these species. This information is critical because poorly executed transfusions can compromise already weakened patients or result in the death of the recipient. In 2014, a retrospective survey of U.S. zoos housing great apes received 45 of 67 responses; from which, 12 transfusion cases in great apes were identified, including Sumatran orangutans ( Pongo pygmaeus sumatraensis, n = 4), chimpanzee ( Pan troglodytes , n = 1), and western lowland gorillas ( Gorilla gorilla gorilla, n = 7). These animals, ranging from birth to 31 yr, received intravenous transfusions of whole blood, packed red blood cells, or human albumin. Overall, animals that received transfusions for anemia because of chronic illness or blood loss survived, but those individuals with concurrent life-threatening issues did not survive. No adverse reactions related to the transfusion occurred, except in two orangutans given human albumin.

Concise review: stem cell-based approaches to red blood cell production for transfusion.

PubMed

Shah, Siddharth; Huang, Xiaosong; Cheng, Linzhao

2014-03-01

Blood transfusion is a common procedure in modern medicine, and it is practiced throughout the world; however, many countries report a less than sufficient blood supply. Even in developed countries where the supply is currently adequate, projected demographics predict an insufficient supply as early as 2050. The blood supply is also strained during occasional widespread disasters and crises. Transfusion of blood components such as red blood cells (RBCs), platelets, or neutrophils is increasingly used from the same blood unit for multiple purposes and to reduce alloimmune responses. Even for RBCs and platelets lacking nuclei and many antigenic cell-surface molecules, alloimmunity could occur, especially in patients with chronic transfusion requirements. Once alloimmunization occurs, such patients require RBCs from donors with a different blood group antigen combination, making it a challenge to find donors after every successive episode of alloimmunization. Alternative blood substitutes such as synthetic oxygen carriers have so far proven unsuccessful. In this review, we focus on current research and technologies that permit RBC production ex vivo from hematopoietic stem cells, pluripotent stem cells, and immortalized erythroid precursors.

The harmonization of the regulation of blood products: a European perspective.

PubMed

Seitz, R; Heiden, M; Nübling, C M; Unger, G; Löwer, J

2008-05-01

The development of blood products as medicines initially took place on the national level in various countries, which resulted in considerable diversity of mechanisms and stringency of regulatory oversight. The scenario changed dramatically with the catastrophic experience that severe virus infections had been transmitted by blood products world-wide. Blood products, which had been regulated differently in the member states, became subject to the European pharmaceutical legislation in 1989. A specialized directive regulating the blood transfusion sector and the collection of plasma for fractionation was enacted in 2002. The European Community, particularly the Commission and the European Medicines Agency, is continuously refining the requirements, providing detailed technical and scientific guidance. In addition, institutions of the Council of Europe play an important role in the transfusion sector, the elaboration of the European Pharmacopoeia prescriptions, and the co-ordination of Official Medicines Control Laboratory or Laboratories batch release. However, further and sustained efforts towards international harmonization are needed. There are already important mechanisms in place, such as the International Conference on Harmonization initiative, which is producing internationally recognized guidelines on central issues. Another important achievement is the common technical document format, which enables the use of uniform applications for marketing authorization. However, there is still room for progress, for example, questions regarding regulatory requirements for licensing of in vitro diagnostic devices, or mutual recognition of inspections. The World Health Organization continues to play an important role in harmonization, both substantially by the production of high-level guidance documents or the establishment of physical international standard preparations, and in a more general sense by providing a platform for international collaboration. A very

Airway and alveolar nitric oxide production, lung function, and pulmonary blood flow in sickle cell disease.

PubMed

Lunt, Alan; Ahmed, Na'eem; Rafferty, Gerrard F; Dick, Moira; Rees, David; Height, Sue; Thein, Swee Lay; Greenough, Anne

2016-02-01

Children with sickle cell disease (SCD) often have obstructive lung function abnormalities which could be due to asthma or increased pulmonary blood volume; it is important to determine the underlying mechanism to direct appropriate treatment. In asthmatics, exhaled nitric oxide (FeNO) is elevated. FeNO, however, can also be raised due to increased alveolar production. Our aim, therefore, was to determine if airway or alveolar NO production differed between SCD children and ethnic and age-matched controls. Lung function, airway NO flux and alveolar NO production, and effective pulmonary blood flow were assessed in 18 SCD children and 18 ethnic and age-matched controls. The SCD children compared to the controls had a higher respiratory system resistance (P = 0.0008), alveolar NO production (P = 0.0224), and pulmonary blood flow (P < 0.0001), but not airway NO flux. There was no significant correlation between FeNO and respiratory system resistance in either group, but in the SCD children, there were correlations between alveolar NO production (P = 0.0006) and concentration (P < 0.0001) and pulmonary blood flow. Airway NO flux was not elevated in the SCD children nor correlated with airways obstruction, suggesting that airways obstruction, at least in some SCD children, is not due to asthma.

Oral warfarin affects peripheral blood leukocyte IL-6 and TNFα production in rats.

PubMed

Popov, Aleksandra; Belij, Sandra; Subota, Vesna; Zolotarevski, Lidija; Mirkov, Ivana; Kataranovski, Dragan; Kataranovski, Milena

2013-01-01

Warfarin is a Vitamin K (VK) antagonist that affects Vitamin K-dependent (VKD) processes, including blood coagulation, as well as processes unrelated to hemostasis such as bone growth, calcification, and growth of some cell types. In addition, warfarin exerts influence on some non-VKD-related activities, including anti-tumor and immunomodulating activity. With respect to the latter, both immune stimulating and suppressive effects have been noted in different experimental systems. To explore the in vivo immunomodulatory potential of warfarin on one type of activity (i.e., cytokine production) in two different immune cell populations (i.e., mononuclear or polymorphonuclear cells), effects of subchronic oral warfarin intake in rats on pro-inflammatory cytokine (i.e., TNFα, IL-6) production by peripheral blood mononuclear and polymorphonuclear cells (granulocytes) was examined. Differential effects of warfarin intake on TNFα and IL-6 were noted, depending on the type of peripheral blood leukocytes and on the cytokine examined. Specifically, a lack of effect on TNFα and a priming of IL-6 production by mononuclear cells along with a decrease in TNFα and a lack of effect on IL-6 in polymorphonuclear cells were seen in warfarin-exposed hosts. The cell- and cytokine-dependent effects from subchronic oral warfarin intake on peripheral blood leukocytes demonstrated in this study could, possibly, differentially affect reactions mediated by these cells. Ultimately, the observed effects in rats might have implications for those humans who are on long-term/prolonged warfarin therapy.

9 CFR 95.14 - Blood meal, tankage, meat meal, and similar products, for use as fertilizer or animal feed...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Blood meal, tankage, meat meal, and..., tankage, meat meal, and similar products, for use as fertilizer or animal feed; requirements for entry. Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and...

Whole Blood Activation Results in Enhanced Detection of T Cell and Monocyte Cytokine Production by Flow Cytometry

NASA Technical Reports Server (NTRS)

Sams, Clarence F.; Crucian, Brian E.

2001-01-01

An excellent monitor of the immune balance of peripheral circulating cells is to determine their cytokine production patterns in response to stimuli. Using flow cytometry a positive identification of cytokine producing cells in a mixed culture may be achieved. Recently, the ability to assess cytokine production following a wholeblood activation culture has been described. We compared whole blood culture to standard PBMC culture and determined the individual cytokine secretion patterns for both T cells and monocytes via flow cytometry. For T cells cytokine assessment following PMA +ionomycin activation: (1) a significantly greater percentages of T cells producing IFNgamma and IL-2 were observed following whole-blood culture; (2) altered T cell cytokine production kinetics were observed by varying whole blood culture times. In addition, a four-color cytometric analysis was used to allow accurate phenotyping and quantitation of cytokine producing lymphocyte populations. Using this technique we found IFNgamma production to be significantly elevated in the CD3+/CD8+ T cell population as compared to the CD3+/CD8- population following five hours of whole blood activation. Conversely, IL-2 and IL-10 production were significantly elevated in the CD3+/CD8- T cell population as compared to the CD3+/CD8+ population. Monocyte cytokine production was assessed in both culture systems following LPS activation for 24 hours. A three-color flow cytometric was used to assess two cytokines in conjunction with CD 14. The cytokine pairs used for analysis were IL-1a/IL-12, and IL-10ITNFa. Nearly all monocytes were stimulated to produce IL-1a, IL-12 and TNFalpha equally well in both culture systems. Monocyte production of IL-10 was significantly elevated following whole blood culture as compared to PBMC culture. IL-12 producing monocytes appeared to be a distinct subpopulation of the IL-1a producing set, whereas IL-10 and TNFa producing monocytes were largely mutually exclusive. IL-10 and

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.

[Traceability of labile blood products in Morocco: experience of the Ibn-Sina hospital of Rabat between 1999 and 2010].

PubMed

Ouadghiri, S; Atouf, O; Brick, C; Benseffaj, N; Essakalli, M

2012-02-01

The blood transfusion and haemovigilance service of the Ibn-Sina hospital in Rabat (Morocco) was created 1997. This unit manages the pretransfusional tests, distribution of blood products, traceability and haemovigilance. The objective of this study was to analyze, over a period of 12years, the traceability of blood products delivered in our hospital and the measures used to improve feedback information. This is a retrospective study conducted between 1999 and 2010. Traceability rate was calculated from the feedback of traceability forms supplied with blood products (number of blood products noted on traceability forms on the total number of delivered product). To improve traceability rate, several actions were undertaken: one-time training, awareness campaigns and call phones asking for feedback information. Between 1999 and 2010, the service has delivered 173,858 blood products. The average rate of traceability during this period was 13.4 %. Traceability rate varies widely over time (5.2 % in 1999, 15.5 % in 2010) and shows a maximum value of 27.2 % in 2005. Feedback information is lower in emergency departments than in medical and surgical services. Feedback information about traceability in Ibn-Sina hospital remains very poor despite the measures used. Other actions, such as continuous education courses, low enforcement and informatisation should be considered. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Blood-alcohol proficiency test program

DOT National Transportation Integrated Search

1975-01-01

A preliminary survey has been performed to ascertain the validity of the blood alcohol analysis performed by a number of laboratories on a voluntary basis. Values of accuracy and precision of the tests are presented. /Abstract from report summary pag...

A survey of the concentrations of eleven metals in vaccines, allergenic extracts, toxoids, blood, blood derivatives and other biological products.

PubMed

May, J C; Rains, T C; Maienthal, F J; Biddle, G N; Progar, J J

1986-10-01

Approximately 85 samples of injectable biological products regulated by the Center for Drugs and Biologics of the United States Food and Drug Administration were surveyed for the presence of 11 elements, namely aluminum, arsenic, barium, cadmium, chromium, lead, mercury, selenium, thallium and zinc, by flame and flameless methods of atomic absorption spectrometry and flame emission spectrometry. The range of products tested included whole blood, red cells, plasma, normal serum albumin, antihemophilic factor, and other products derived from blood; allergenic extracts including honey bee venom and house dust allergenic extracts; vaccines such as measles virus vaccine and typhoid vaccine; and tetanus toxoid. The metal concentrations found in the majority of these products were low or undetectable. The metal levels varied from manufacturer to manufacturer, product and lot-to-lot of the same manufacturer's products. House dust allergenic extracts had the highest concentrations of arsenic (2.4 ppm), cadmium (0.28 ppm), chromium (0.6 ppm) and lead (1.5 ppm) found in the study. A high zinc concentration (24 ppm) in an immune serum globulin was attributed to the zinc-containing rubber stopper in contact with the product. A range of 0.36-3.30 ppm aluminum was found for seven 25% normal serum albumin samples from seven manufacturers. Values of 8.2, 17 and 18 ppm aluminum were found in one manufacturer's 25% normal serum albumin. These aluminum values appeared to be the result of an anomaly in this manufacturer's production that has not been repeated to date.

Eliminating the use of allogeneic blood products in adolescent idiopathic scoliosis surgery.

PubMed

Berney, Mark J; Dawson, Peter H; Phillips, Margaret; Lui, Darren F; Connolly, Paul

2015-07-01

The aim of this study was to compare transfusion requirements in patients before and after the introduction of tranexamic acid as standard in patients undergoing spinal surgery for idiopathic scoliosis in a national orthopaedic hospital. A retrospective chart review of 56 idiopathic scoliosis patients who underwent posterior spinal instrumentation and fusion between 2009 and 2013 at our institution. Preoperative, intraoperative, and postoperative data were measured. Patients who received tranexamic acid as standard (n = 31) showed a trend towards a decrease in transfusion requirements compared with those who received no tranexamic acid (n = 25). These patients had a statistically significant decrease in operative time (223 vs 188 min, p = 0.005), and estimated intraoperative blood loss was reduced by nearly 50% in the tranexamic acid group. They also had an associated reduced decrease in haemoglobin between preoperative and postoperative levels (4 vs 5 g/dL, p = 0.01). Since February 2012, no patient has required intraoperative or postoperative allogeneic blood product transfusion in this hospital. The routine use of antifibrinolytic medications in patients undergoing surgery for adolescent idiopathic scoliosis has effectively eliminated the need for allogeneic blood products.

How do I provide leukapheresis products? Blood center experience and evidence for process improvement.

PubMed

Ginzburg, Yelena; Kessler, Debra; Narici, Manlio; Caltabiano, Melinda; Rebosa, Mark; Strauss, Donna; Shaz, Beth

2013-10-01

The past few decades have seen a resurgence of interest in leukapheresis products to improve the survival of infected patients with neutropenia. These products have a short shelf life and require donor stimulation with dexamethasone before collection. Additionally, a system with good communications and logistical support is essential. A recent survey of blood centers in North America revealed that the majority of centers collecting leukapheresis products use steroid-stimulated donors. The survey results suggested that an analysis of the process and potential process improvement would be of interest to the transfusion medicine community. Data from 2008 to 2011 regarding donor selection, donor dexamethasone stimulation, leukapheresis collection, and correlations between potentially pertinent variables for process improvement were analyzed. Results from an analysis of cost are also included. We evaluate 432 leukapheresis donations and demonstrate correlations between 1) pre- and poststimulation white blood cell (WBC) count (p<0.0001), 2) interval (donor stimulation to collection) and poststimulation WBC count (p<0.0001), and 3) poststimulation WBC count and leukapheresis product granulocyte yield (p<0.0001). Significant improvement in granulocyte quality and yield can be accomplished in dexamethasone-stimulated donors, by selecting eligible donors with relatively high normal prestimulation WBC counts and/or previously good responses to dexamethasone, increasing the duration between dexamethasone stimulation and granulocyte collection, and maintaining optimal hematocrit (5%-10%) in granulocyte collections. Because the majority of surveyed blood centers collecting stimulated granulocytes use steroids alone, modifications presented here may prove useful. Further assessment of correlation between granulocyte yield and clinical outcome will await results of additional studies. © 2012 American Association of Blood Banks.

Development of blood transfusion product pathogen reduction treatments: a review of methods, current applications and demands.

PubMed

Salunkhe, Vishal; van der Meer, Pieter F; de Korte, Dirk; Seghatchian, Jerard; Gutiérrez, Laura

2015-02-01

Transfusion-transmitted infections (TTI) have been greatly reduced in numbers due to the strict donor selection and screening procedures, i.e. the availability of technologies to test donors for endemic infections, and routine vigilance of regulatory authorities in every step of the blood supply chain (collection, processing and storage). However, safety improvement is still a matter of concern because infection zero-risk in transfusion medicine is non-existent. Alternatives are required to assure the safety of the transfusion product and to provide a substitution to systematic blood screening tests, especially in less-developed countries or at the war-field. Furthermore, the increasing mobility of the population due to traveling poses a new challenge in the endemic screening tests routinely used, because non-endemic pathogens might emerge in a specific population. Pathogen reduction treatments sum a plethora of active approaches to eliminate or reduce potential threatening pathogen load from blood transfusion products. Despite the success of pathogen reduction treatments applied to plasma products, there is still a long way to develop and deploy pathogen reduction treatments to cellular transfusion products (such as platelets, RBCs or even to whole blood) and there is divergence on its acceptance worldwide. While the use of pathogen reduction treatments in platelets is performed routinely in a fair number of European blood banks, most of these treatments are not (or just) licensed in the USA or elsewhere in the world. The development of pathogen reduction treatments for RBC and whole blood is still in its infancy and under clinical trials. In this review, we discuss the available and emerging pathogen reduction treatments and their advantages and disadvantages. Furthermore, we highlight the importance of characterizing standard transfusion products with current and emerging approaches (OMICS) and clinical outcome, and integrating this information on a database

NOAA's State Climate Summaries for the National Climate Assessment: A Sustained Assessment Product

NASA Astrophysics Data System (ADS)

Kunkel, K.; Champion, S.; Frankson, R.; Easterling, D. R.; Griffin, J.; Runkle, J. D.; Stevens, L. E.; Stewart, B. C.; Sun, L.; Veasey, S.

2016-12-01

A set of State Climate Summaries have been produced for all 50 U.S. states as part of the National Climate Assessment Sustained Assessment and represent a NOAA contribution to this process. Each summary includes information on observed and projected climate change conditions and impacts associated with future greenhouse gas emissions pathways. The summaries focus on the physical climate and coastal issues as a part of NOAA's mission. Core climate data and simulations used to produce these summaries have been previously published, and have been analyzed to represent a targeted synthesis of historical and plausible future climate conditions. As these are intended to be supplemental to major climate assessment development, the scope of the content remains true to a "summary" style document. Each state's Climate Summary includes its climatology and projections of future temperatures and precipitation, which are presented in order to provide a context for the assessment of future impacts. The climatological component focuses on temperature, precipitation, and noteworthy weather events specific to each state and relevant to the climate change discussion. Future climate scenarios are also briefly discussed, using well-known and consistent sets of climate model simulations based on two possible futures of greenhouse gas emissions. These future scenarios present an internally consistent climate picture for every state and are intended to inform the potential impacts of climate change. These 50 State Climate Summaries were produced by NOAA's National Centers for Environmental Information (NCEI) and the North Carolina State University Cooperative Institute for Climate and Satellites - NC (CICS-NC) with additional input provided by climate experts, including the NOAA Regional Climate Centers and State Climatologists. Each summary document also underwent a comprehensive and anonymous peer review. Each summary contains text, figures, and an interactive web presentation. A full

Wide variations in blood product transfusion practices among providers who care for patients with acute leukemia in the United States.

PubMed

Pine, Alexander B; Lee, Eun-Ju; Sekeres, Mikkael; Steensma, David P; Zelterman, Daniel; Prebet, Thomas; DeZern, Amy; Komrokji, Rami; Litzow, Mark; Luger, Selina; Stone, Richard; Erba, Harry P; Garcia-Manero, Guillermo; Lee, Alfred I; Podoltsev, Nikolai A; Barbarotta, Lisa; Kasberg, Stephanie; Hendrickson, Jeanne E; Gore, Steven D; Zeidan, Amer M

2017-02-01

Transfusion of blood products is a key component of the supportive management in patients with acute leukemia (AL). However high-quality trial evidence and clinical outcome data to support specific transfusion goals for blood products for patients with AL remain limited leading to diverse transfusion practices. The primary objective of this study was to determine the spectrum of transfusion patterns in a variety of care settings among providers who treat AL patients. A 31-question survey queried providers caring for AL patients about the existence of institutional guidelines for transfusion of blood products, transfusion triggers for hemoglobin (Hb), platelets (PLTs), and fibrinogen in various settings including inpatient and outpatient and before procedures. We analyzed 130 responses and identified divergent transfusion Hb goals in hospitalized and ambulatory patients, fibrinogen goals for cryoprecipitate transfusions, and variation in practice for use of certain PLTs and red blood cell products. The least variable transfusion patterns were reported for PLT goals in thrombocytopenia and in the setting of invasive procedures such as bone marrow biopsy and lumbar punctures. This survey confirmed wide variations in blood product transfusion practices across several clinical scenarios in patients with AL. The findings emphasized the need for large prospective randomized trials to develop standardized evidence-based guidelines for blood product transfusions in patients with AL with the goal of limiting unnecessary transfusions without compromising outcomes. © 2016 AABB.

Screen of micro-organisms for inducing the production of dragon's blood by leaf of Dracaena cochinchinensis.

PubMed

Wang, X H; Zhang, C H; Wang, Y; Gomes-Laranjo, J

2010-11-01

To screen micro-organisms for inducing the production of dragon's blood, which is normally produced by stem xylem and by leaf of Dracaena cochinchinensis, and to evaluate the product by comparing with the standard. Thirty microbial strains were isolated from D. cochinchinensis leaves. Three of them were confirmed to elicit the leaf of D. cochinchinensis producing dragon's blood after inoculation. Upon elicitation, all of the 6-month-old leaves of the inducible trees produced dragon's blood; 60-70% of the 1-year-old leaves elicited produced the resin. All the three strains were identified as Colletotrichum gloeosporioide by morphological and molecular methods. The leaf resin had a similar TLC profile and antioxidant activities to the standard resin. In particular, it had a higher total flavonol content and antimicrobial activity than the standard. Upon the induction of the screened C. gloeosporioide mycelia, D. cochinchinensis leaf produced dragon's blood with higher total flavone content and antimicrobial activity than the standard dragon's blood. This work has provided a strategy for producing dragon's blood in a sustainable way using leaves of C. gloeosporioides by fungal elicitation. © 2010 The Authors. © 2010 The Society for Applied Microbiology.

Blockade of invariant TCR-CD1d interaction specifically inhibits antibody production against blood group A carbohydrates

PubMed Central

Tazawa, Hirofumi; Irei, Toshimitsu; Tanaka, Yuka; Igarashi, Yuka; Tashiro, Hirotaka

2013-01-01

Previously, we detected B cells expressing receptors for blood group A carbohydrates in the CD11b+CD5+ B-1a subpopulation in mice, similar to that in blood group O or B in humans. In the present study, we demonstrate that CD1d-restricted natural killer T (NKT) cells are required to produce anti-A antibodies (Abs), probably through collaboration with B-1a cells. After immunization of wild-type (WT) mice with human blood group A red blood cells (A-RBCs), interleukin (IL)-5 exclusively and transiently increased and the anti-A Abs were elevated in sera. However, these reactions were not observed in CD1d−/− mice, which lack NKT cells. Administration of anti-mouse CD1d blocking monoclonal Abs (mAb) prior to immunization abolished IL-5 production by NKT cells and anti-A Ab production in WT mice. Administration of anti-IL-5 neutralizing mAb also diminished anti-A Ab production in WT mice, suggesting that IL-5 secreted from NKT cells critically regulates anti-A Ab production by B-1a cells. In nonobese diabetic/severe combined immunodeficient (NOD/SCID/γcnull) mice, into which peripheral blood mononuclear cells from type O human volunteers were engrafted, administration of anti-human CD1d mAb prior to A-RBC immunization completely inhibited anti-A Ab production. Thus, anti-CD1d treatment might constitute a novel approach that could help in evading Ab-mediated rejection in ABO-incompatible transplant recipients. PMID:23943651

21 CFR 607.22 - How and where to register establishments and list blood products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true How and where to register establishments and list blood products. 607.22 Section 607.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR...

21 CFR 607.22 - How and where to register establishments and list blood products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false How and where to register establishments and list blood products. 607.22 Section 607.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR...

Impact of intraoperative factor concentrates on blood product transfusions during orthotopic liver transplantation.

PubMed

Colavecchia, A Carmine; Cohen, David A; Harris, Jesse E; Thomas, Jeena M; Lindberg, Scott; Leveque, Christopher; Salazar, Eric

2017-12-01

Major bleeding in orthotopic liver transplantation is associated with significant morbidity and mortality. Limited literature exists regarding comparative effectiveness of prothrombin complex concentrate and fibrinogen concentrate during orthotopic liver transplantation on blood product utilization. This retrospective, single-institution study evaluated the impact of prothrombin complex concentrate and fibrinogen concentrate on blood product utilization during orthotopic liver transplantation from December 2013 to April 2016. This study included patients age 18 years or older and excluded patients who received simultaneous heart or lung transplantation or did not meet documentation criteria. A propensity score matching technique was used to match patients who were exposed to prothrombin complex concentrate with unexposed patients, at a 2 to 1 ratio, to control for selection bias. During this study, 212 patients received orthotopic liver transplantation with 39 prothrombin complex concentrate exposures. The matched study population included 39 patients who were exposed to prothrombin complex concentrate and 78 unexposed patients. Overall, 84.6% of patients who were exposed to prothrombin complex concentrate also received concomitant fibrinogen concentrate, whereas only 2% of patients in the control group received fibrinogen concentrate. After propensity score matching, no other factors that were included in the model differed significantly or had a standardized mean difference of 0.11 or greater. There was no statistical difference in the utilization of red blood cells or fresh frozen plasma for the exposed group versus the unexposed group after matching (mean ± standard deviation: red blood cell units, 12.4 ± 8.0 units vs. 9.7 ± 5.6 units [p = 0.058]; fresh-frozen plasma units, 10.0 ± 6.3 vs. 12.7 ± 9.7 units [p = 0.119], respectively). The intraoperative use of prothrombin complex concentrate and fibrinogen concentrate during

16 CFR 1610.3 - Summary of test method.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Summary of test method. 1610.3 Section 1610.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES The Standard § 1610.3 Summary of test method. The Standard...

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PubMed Central

Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

2015-01-01

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

The effect of aprotinin, tranexamic acid, and aminocaproic acid on blood loss and use of blood products in major pediatric surgery: a meta-analysis.

PubMed

Schouten, Esther S; van de Pol, Alma C; Schouten, Anton N J; Turner, Nigel M; Jansen, Nicolaas J G; Bollen, Casper W

2009-03-01

Aprotinin reduces the blood loss and transfusion of blood products in children undergoing major surgery. Aprotinin has been associated with severe side effects in adults, and tranexamic acid and aminocaproic acid have been found to be safer alternatives in adults. This systematic review addresses the question of whether tranexamic acid and aminocaproic acid are equally effective as aprotinin for reducing blood loss and transfusion in children undergoing major surgery. A systematic review of the literature was conducted to identify all randomized controlled trials of aprotinin, tranexamic acid, and aminocaproic acid involving children undergoing cardiac or scoliosis surgery. Twenty-three cardiac studies, totaling 1893 patients, met the inclusion criteria. None of the studies directly compared aprotinin to an alternative antifibrinolytic. Five scoliosis studies, totaling 207 patients, met the inclusion criteria. Data on blood loss and use of blood products in the first 24 postoperative hours were extracted. Only homogenously distributed outcomes were pooled. Tranexamic acid showed a homogeneously distributed reduction of blood loss by 11 mL/kg (95% confidence interval [CI] 9-13 mL/kg). Outcomes of blood loss reduction by aprotinin and aminocaproic acid were too heterogeneously distributed to be pooled, so the effect on blood loss could not be evaluated. Both aprotinin and tranexamic acid significantly reduced packed red cell transfusion (4 mL/kg, 95% CI 2-7 mL/kg and 7 mL/kg, 95% CI 5-10 mL/kg, respectively). Type of antifibrinolytic was not a determining factor that explained differences in outcome among trials in a meta-regression analysis. In the scoliosis studies, aprotinin and tranexamic acid significantly reduced blood loss compared with placebo (385 mL, 95% CI 727-42 mL and 682 mL, 95% CI 1149-214 mL, respectively). There is no evidence that suggests that, compared with aprotinin, alternative antifibrinolytics such as tranexamic acid were less effective in

Risk Management Analysis of Air Ambulance Blood Product Administration in Combat Operations

DTIC Science & Technology

2014-11-01

examining pre-hospital blood product use substantiated that re- mote transfusion programs can deliver life-saving ther- apy without waste. In a series...combat casualty patients . J Trauma 2008 ; 64 : S57 – 63 . 15. Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton

ENDF/B summary documentation

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

Kinsey, R.

1979-07-01

This publication provides a localized source of descriptions for the evaluations contained in the ENDF/B Library. The summary documentation presented is intended to be a more detailed description than the (File 1) comments contained in the computer readable data files, but not so detailed as the formal reports describing each ENDF/B evaluation. The summary documentations were written by the CSEWB (Cross Section Evaluation Working Group) evaluators and compiled by NNDC (National Nuclear Data Center). This edition includes documentation for materials found on ENDF/B Version V tapes 501 to 516 (General Purpose File) excluding tape 504. ENDF/B-V also includes tapes containingmore » partial evaluations for the Special Purpose Actinide (521, 522), Dosimetry (531), Activation (532), Gas Production (533), and Fission Product (541-546) files. The materials found on these tapes are documented elsewhere. Some of the evaluation descriptions in this report contain cross sections or energy level information. (RWR)« less

21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood storage refrigerator and blood storage... Establishments That Manufacture Blood and Blood Products § 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended...

21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood storage refrigerator and blood storage... Establishments That Manufacture Blood and Blood Products § 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended...

21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood storage refrigerator and blood storage... Establishments That Manufacture Blood and Blood Products § 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended...

21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood storage refrigerator and blood storage... Establishments That Manufacture Blood and Blood Products § 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended...

21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood storage refrigerator and blood storage... Establishments That Manufacture Blood and Blood Products § 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended...

User Guide for State Summaries

EPA Pesticide Factsheets

The EPA developed state-level summaries of chemical and water use using the project database developed from FracFocus 1.0 disclosures with some limited background information on oil and gas production, geology, and regulations for the state.

9 CFR 95.14 - Blood meal, tankage, meat meal, and similar products, for use as fertilizer or animal feed...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Blood meal, tankage, meat meal, and... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.14 Blood meal.... Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and...

9 CFR 95.14 - Blood meal, tankage, meat meal, and similar products, for use as fertilizer or animal feed...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Blood meal, tankage, meat meal, and... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.14 Blood meal.... Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and...

9 CFR 95.14 - Blood meal, tankage, meat meal, and similar products, for use as fertilizer or animal feed...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Blood meal, tankage, meat meal, and... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.14 Blood meal.... Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and...

Studies on the mechanism of endogenous pyrogen production. III. Human blood monocytes.

PubMed

Bodel, P

1974-10-01

The characteristics of pyrogen production and release by human blood monocytes were investigated. A dose-response assay of monocyte pyrogen in rabbits indicated a linear relationship of temperature elevation to dose of pyrogen at lower doses. Monocytes did not contain pyrogen when first obtained, nor did they release it spontaneously even after 5 days of incubation in vitro. Pyrogen production was apparent 4 h after stimulation by endotoxin or phagocytosis, and continued for 24 h or more. Puromycin, an inhibitor of protein synthesis, prevented both initiation and continuation of pyrogen production and release. Pyrogen-containing supernates retained most pyrogenic activity during overnight incubation even in the presence of activated cells. Lymphocytes appeared to play no role in either initiation or continuation of pyrogen production in these studies.

Altered Cytokine Production By Specific Human Peripheral Blood Cell Subsets Immediately Following Spaceflight

NASA Technical Reports Server (NTRS)

Crucian, Brian E.; Cubbage, Michael L.; Sams, Clarence F.

1999-01-01

In this study, we have attempted to combine standard immunological assays with the cellular resolving power of the flow cytometer to positively identify the specific cell types involved in spaceflight-induced immune alterations. We have obtained whole blood samples from 27 astronauts collected at three timepoints (L-10, R+0 and R+3) surrounding four recent space shuttle missions. The duration of these missions ranged from 10 to 18 days. Assays performed included serum/urine cortisol, comprehensive subset phenotyping, assessment of cellular activation markers and intracellular cytokine production following mitogenic stimulation. Absolute levels of peripheral granulocytes were significantly elevated following spaceflight, but the levels of circulating lymphocytes and monocytes were unchanged. Lymphocyte subset analysis demonstrated trends towards a decreased percentage of T cells and an increased percentage of B cells. Nearly all of the astronauts exhibited an increased CD4:CD8 ratio, which was dramatic in some individuals. Assessment of memory (CD45RA+) vs. naive (CD45RO+) CD4+ T cell subsets was more ambiguous, with subjects tending to group more as a flight crew. All subjects from one mission demonstrated an increased CD45RA:CD45RO ratio, while all subjects from another Mission demonstrated a decreased ratio. While no significant trend was seen in the monocyte population as defined by scatter, a decreased percentage of the CD14+ CD16+ monocyte subset was seen following spaceflight in all subjects tested. In general, most of the cellular changes described above which were assessed at R+O and compared to L-10 trended to pre-flight levels by R+3. Although no significant differences were seen in the expression of the cellular activation markers CD69 and CD25 following exposure to microgravity, significant alterations were seen in cytokine production in response to mitogenic activation for specific subsets. T cell (CD3+) production of IL-2 was significantly decreased

Nonsteroidal anti-inflammatory drugs increase TNF production in rheumatoid synovial membrane cultures and whole blood.

PubMed

Page, Theresa H; Turner, Jeremy J O; Brown, Anthony C; Timms, Emma M; Inglis, Julia J; Brennan, Fionula M; Foxwell, Brian M J; Ray, Keith P; Feldmann, Marc

2010-09-15

Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase activity and hence PG production. However, the ability of NSAIDs to ameliorate pain and tenderness does not prevent disease progression in rheumatoid arthritis, a disease whose pathogenesis is linked to the presence of proinflammatory cytokines, such as TNF-alpha. To understand this observation, we have examined the effect of NSAIDs on the production of clinically validated proinflammatory cytokines. We show that a variety of NSAIDs superinduce production of TNF from human peripheral blood monocytes and rheumatoid synovial membrane cultures. A randomized, double-blinded, crossover, placebo-controlled trial in healthy human volunteers also revealed that the NSAID drug celecoxib increased LPS-induced TNF production in whole blood. NSAID-mediated increases in TNF are reversed by either the addition of exogenous PGE(2) or by a PGE(2) EP2 receptor agonist, revealing that PGE(2) signaling via its EP2 receptor provides a valuable mechanism for controlling excess TNF production. Thus, by reducing the level of PGE(2), NSAIDs can increase TNF production and may exacerbate the proinflammatory environment both within the rheumatoid arthritis joint and the systemic environment.

The National Blood Service. Supporting better blood transfusion.

PubMed

Gerrard, Rebecca

2004-05-01

The National Blood Service (NBS) is an integral part of the National Health Service that provides blood, blood components, blood products and tissues from fifteen blood centres to England and North Wales. Each year, the NBS collects tests, processes, stores and issues approximately 2.3 million blood donations. The service also undertakes research into blood safety, provides clinical advice to hospital staff and supports hospital transfusion practitioners. Rebecca Gerrard describes some of the initiatives to improve blood transfusion practices, including monitoring of the serious hazards of transfusion, bench marking schemes and the roles of blood transfusion liaison (BTL) nurses.

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

PubMed Central

Wang, J; Johnson, T; Sahin, L; Tassinari, MS; Anderson, PO; Baker, TE; Bucci-Rechtweg, C; Burckart, GJ; Chambers, CD; Hale, TW; Johnson-Lyles, D; Nelson, RM; Nguyen, C; Pica-Branco, D; Ren, Z; Sachs, H; Sauberan, J; Zajicek, A; Ito, S; Yao, LP

2017-01-01

This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants. PMID:28510297

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

Establishment and performance assessment of preparation technology of internal quality control products for blood transfusion compatibility testing.

PubMed

Yu, Yang; Ma, Chunya; Feng, Qian; Chen, Xin; Guan, Xiaozhen; Zhang, Xiaojuan; Chen, Linfeng; Lin, Zilin; Pan, Jichun; Zhang, Ting; Luo, Qun; Wang, Deqing

2013-05-01

The aim of this study was to establish and to optimize the preparation technology of whole blood internal quality control (IQC) products for blood transfusion compatibility testing. Several B-type RhD-negative blood samples collected from healthy donors were mixed. Two groups of whole blood IQC products, namely, the preservative solution group (PS group) and the saline group, were prepared. The agglutination intensity of IQC sample red cells and anti-B antibody, IgM anti-A antibody and reverse-typing A cell, IgG anti-D and O-type RhD-positive red cells, as well as free hemoglobin concentration in the supernatant of the two groups were detected. The erythrocytes in both groups were damaged to a certain extent during storage, but no evident (above moderate) hemolysis was observed in the stored sample within 42 days. The red cells remained structurally complete and the reaction activity of IgG anti-D reagent remained generally unchanged (P>0.05). Although the reaction activity oscillation of IgM anti-A reagent was observed, the agglutination intensity varied within an acceptable range of 1+. No difference was observed between the preparation methods of the samples, i.e., between the erythrocyte washed with saline and the one washed with red cell preservative solution (P>0.05). The long shelf life, low variance between tubes and stable antigen-antibody reaction activity of the whole blood IQC products prepared using the proposed method can meet the requirements of blood transfusion compatibility testing.

Contribution of midgut bacteria to blood digestion and egg production in aedes aegypti (diptera: culicidae) (L.)

PubMed Central

2011-01-01

Background The insect gut harbors a variety of microorganisms that probably exceed the number of cells in insects themselves. These microorganisms can live and multiply in the insect, contributing to digestion, nutrition, and development of their host. Recent studies have shown that midgut bacteria appear to strengthen the mosquito's immune system and indirectly enhance protection from invading pathogens. Nevertheless, the physiological significance of these bacteria for mosquitoes has not been established to date. In this study, oral administration of antibiotics was employed in order to examine the contribution of gut bacteria to blood digestion and fecundity in Aedes aegypti. Results The antibiotics carbenicillin, tetracycline, spectinomycin, gentamycin and kanamycin, were individually offered to female mosquitoes. Treatment of female mosquitoes with antibiotics affected the lysis of red blood cells (RBCs), retarded the digestion of blood proteins and reduced egg production. In addition, antibiotics did not affect the survival of mosquitoes. Mosquito fertility was restored in the second gonotrophic cycle after suspension of the antibiotic treatment, showing that the negative effects of antibiotics in blood digestion and egg production in the first gonotrophic cycle were reversible. Conclusions The reduction of bacteria affected RBC lysis, subsequently retarded protein digestion, deprived mosquito from essential nutrients and, finally, oocyte maturation was affected, resulting in the production of fewer viable eggs. These results indicate that Ae. aegypti and its midgut bacteria work in synergism to digest a blood meal. Our findings open new possibilities to investigate Ae. aegypti-associated bacteria as targets for mosquito control strategies. PMID:21672186

Sampling methods to the statistical control of the production of blood components.

PubMed

Pereira, Paulo; Seghatchian, Jerard; Caldeira, Beatriz; Santos, Paula; Castro, Rosa; Fernandes, Teresa; Xavier, Sandra; de Sousa, Gracinda; de Almeida E Sousa, João Paulo

2017-12-01

The control of blood components specifications is a requirement generalized in Europe by the European Commission Directives and in the US by the AABB standards. The use of a statistical process control methodology is recommended in the related literature, including the EDQM guideline. The control reliability is dependent of the sampling. However, a correct sampling methodology seems not to be systematically applied. Commonly, the sampling is intended to comply uniquely with the 1% specification to the produced blood components. Nevertheless, on a purely statistical viewpoint, this model could be argued not to be related to a consistent sampling technique. This could be a severe limitation to detect abnormal patterns and to assure that the production has a non-significant probability of producing nonconforming components. This article discusses what is happening in blood establishments. Three statistical methodologies are proposed: simple random sampling, sampling based on the proportion of a finite population, and sampling based on the inspection level. The empirical results demonstrate that these models are practicable in blood establishments contributing to the robustness of sampling and related statistical process control decisions for the purpose they are suggested for. Copyright © 2017 Elsevier Ltd. All rights reserved.

Blood Groups in Infection and Host Susceptibility

PubMed Central

2015-01-01

SUMMARY Blood group antigens represent polymorphic traits inherited among individuals and populations. At present, there are 34 recognized human blood groups and hundreds of individual blood group antigens and alleles. Differences in blood group antigen expression can increase or decrease host susceptibility to many infections. Blood groups can play a direct role in infection by serving as receptors and/or coreceptors for microorganisms, parasites, and viruses. In addition, many blood group antigens facilitate intracellular uptake, signal transduction, or adhesion through the organization of membrane microdomains. Several blood groups can modify the innate immune response to infection. Several distinct phenotypes associated with increased host resistance to malaria are overrepresented in populations living in areas where malaria is endemic, as a result of evolutionary pressures. Microorganisms can also stimulate antibodies against blood group antigens, including ABO, T, and Kell. Finally, there is a symbiotic relationship between blood group expression and maturation of the gastrointestinal microbiome. PMID:26085552

Summary of the Energy Policy Act

EPA Pesticide Factsheets

Provides a summary of the Energy Policy Act, which addresses energy production in the United States, energy efficiency; renewable energy; oil and gas; coal; vehicles and motor fuels, and climate change technology.

Normothermic machine perfusion of donor livers without the need for human blood products

PubMed Central

Matton, Alix P. M.; Burlage, Laura C.; van Rijn, Rianne; de Vries, Yvonne; Karangwa, Shanice A.; Nijsten, Maarten W.; Gouw, Annette S. H.; Wiersema‐Buist, Janneke; Adelmeijer, Jelle; Westerkamp, Andrie C.; Lisman, Ton

2018-01-01

Normothermic machine perfusion (NMP) enables viability assessment of donor livers prior to transplantation. NMP is frequently performed by using human blood products including red blood cells (RBCs) and fresh frozen plasma (FFP). Our aim was to examine the efficacy of a novel machine perfusion solution based on polymerized bovine hemoglobin‐based oxygen carrier (HBOC)‐201. Twenty‐four livers declined for transplantation were transported by using static cold storage. Upon arrival, livers underwent NMP for 6 hours using pressure‐controlled portal and arterial perfusion. A total of 12 livers were perfused using a solution based on RBCs and FFPs (historical cohort), 6 livers with HBOC‐201 and FFPs, and another 6 livers with HBOC‐201 and gelofusine, a gelatin‐based colloid solution. Compared with RBC + FFP perfused livers, livers perfused with HBOC‐201 had significantly higher hepatic adenosine triphosphate content, cumulative bile production, and portal and arterial flows. Biliary secretion of bicarbonate, bilirubin, bile salts, and phospholipids was similar in all 3 groups. The alanine aminotransferase concentration in perfusate was lower in the HBOC‐201–perfused groups. In conclusion, NMP of human donor livers can be performed effectively using HBOC‐201 and gelofusine, eliminating the need for human blood products. Perfusing livers with HBOC‐201 is at least similar to perfusion with RBCs and FFP. Some of the biomarkers of liver function and injury even suggest a possible superiority of an HBOC‐201–based perfusion solution and opens a perspective for further optimization of machine perfusion techniques. Liver Transplantation 24 528–538 2018 AASLD. PMID:29281862

Gap Junction Proteins in the Blood-Brain Barrier Control Nutrient-Dependent Reactivation of Drosophila Neural Stem Cells

PubMed Central

Spéder, Pauline; Brand, Andrea H.

2014-01-01

Summary Neural stem cells in the adult brain exist primarily in a quiescent state but are reactivated in response to changing physiological conditions. How do stem cells sense and respond to metabolic changes? In the Drosophila CNS, quiescent neural stem cells are reactivated synchronously in response to a nutritional stimulus. Feeding triggers insulin production by blood-brain barrier glial cells, activating the insulin/insulin-like growth factor pathway in underlying neural stem cells and stimulating their growth and proliferation. Here we show that gap junctions in the blood-brain barrier glia mediate the influence of metabolic changes on stem cell behavior, enabling glia to respond to nutritional signals and reactivate quiescent stem cells. We propose that gap junctions in the blood-brain barrier are required to translate metabolic signals into synchronized calcium pulses and insulin secretion. PMID:25065772

[Innovative technology and blood safety].

PubMed

Begue, S; Morel, P; Djoudi, R

2016-11-01

If technological innovations are not enough alone to improve blood safety, their contributions for several decades in blood transfusion are major. The improvement of blood donation (new apheresis devices, RFID) or blood components (additive solutions, pathogen reduction technology, automated processing of platelets concentrates) or manufacturing process of these products (by automated processing of whole blood), all these steps where technological innovations were implemented, lead us to better traceability, more efficient processes, quality improvement of blood products and therefore increased blood safety for blood donors and patients. If we are on the threshold of a great change with the progress of pathogen reduction technology (for whole blood and red blood cells), we hope to see production of ex vivo red blood cells or platelets who are real and who open new conceptual paths on blood safety. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

21 CFR 640.10 - Red Blood Cells.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.10 Red Blood Cells. The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Red Blood Cells. 640.10 Section 640.10 Food and...

21 CFR 640.10 - Red Blood Cells.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.10 Red Blood Cells. The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Red Blood Cells. 640.10 Section 640.10 Food and...

21 CFR 640.10 - Red Blood Cells.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.10 Red Blood Cells. The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Red Blood Cells. 640.10 Section 640.10 Food and...

21 CFR 640.10 - Red Blood Cells.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.10 Red Blood Cells. The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Red Blood Cells. 640.10 Section 640.10 Food and...

21 CFR 640.10 - Red Blood Cells.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Red Blood Cells. 640.10 Section 640.10 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.10 Red Blood Cells. The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining...

21 CFR 640.1 - Whole Blood.

Code of Federal Regulations, 2010 CFR

2010-04-01

... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.1 Whole Blood. The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Whole Blood. 640.1 Section 640.1 Food and Drugs...

21 CFR 640.1 - Whole Blood.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Whole Blood. 640.1 Section 640.1 Food and Drugs... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.1 Whole Blood. The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion...

21 CFR 640.1 - Whole Blood.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Whole Blood. 640.1 Section 640.1 Food and Drugs... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.1 Whole Blood. The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion...

21 CFR 640.1 - Whole Blood.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Whole Blood. 640.1 Section 640.1 Food and Drugs... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.1 Whole Blood. The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion...

21 CFR 640.1 - Whole Blood.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Whole Blood. 640.1 Section 640.1 Food and Drugs... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.1 Whole Blood. The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion...

21 CFR 607.25 - Information required for establishment registration and blood product listing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Information required for establishment registration and blood product listing. 607.25 Section 607.25 Food and Drugs FOOD AND DRUG ADMINISTRATION... the manufacturer issued by the Center for Biologics Evaluation and Research, Food and Drug...

21 CFR 607.25 - Information required for establishment registration and blood product listing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Information required for establishment registration and blood product listing. 607.25 Section 607.25 Food and Drugs FOOD AND DRUG ADMINISTRATION... the manufacturer issued by the Center for Biologics Evaluation and Research, Food and Drug...

Feed-derived volatile basic nitrogen increases reactive oxygen species production of blood leukocytes in lactating dairy cows.

PubMed

Tsunoda, Ei; Gross, Josef J; Kawashima, Chiho; Bruckmaier, Rupert M; Kida, Katsuya; Miyamoto, Akio

2017-01-01

The present study investigated over 9 months the changes of fermentative quality of total mixed rations (TMR) containing grass silage (GS) as a major component, associated with changes in the volatile basic nitrogen (VBN) levels in an experimental dairy farm. Effects of VBN levels in TMR on metabolic parameters, reactive oxygen species (ROS) production by blood polymorphonuclear leukocytes (PMNs) and conception rates for dairy cows were analyzed. According to VBN levels in TMR during survey periods, three distinct phases were identified; phase A with low VBN; phase B with high VBN; and phase C with mid-VBN. Metabolic parameters in blood were all within normal range. However, during phases B and C, nitrogen metabolic indices such as blood urea nitrogen and milk urea nitrogen showed higher levels compared to those in phase A, and a simultaneous increase in ROS production by blood PMNs and the load on hepatic function in metabolic parameters was observed in the cows with a lower conception rate. This suggests that feeding TMR with elevated VBN levels due to poor fermented GS results in stimulation of ROS production by PMNs by ammonia, and negatively affects metabolism and reproductive performance in lactating dairy cow. © 2016 Japanese Society of Animal Science.

27 CFR 555.127 - Daily summary of magazine transactions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... each magazine. Not later than the close of the next business day, each licensee and permittee shall... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Daily summary of magazine....127 Daily summary of magazine transactions. In taking the inventory required by §§ 555.122, 555.123...

27 CFR 555.127 - Daily summary of magazine transactions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... each magazine. Not later than the close of the next business day, each licensee and permittee shall... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Daily summary of magazine....127 Daily summary of magazine transactions. In taking the inventory required by §§ 555.122, 555.123...

27 CFR 555.127 - Daily summary of magazine transactions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... each magazine. Not later than the close of the next business day, each licensee and permittee shall... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Daily summary of magazine....127 Daily summary of magazine transactions. In taking the inventory required by §§ 555.122, 555.123...

27 CFR 555.127 - Daily summary of magazine transactions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... each magazine. Not later than the close of the next business day, each licensee and permittee shall... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Daily summary of magazine....127 Daily summary of magazine transactions. In taking the inventory required by §§ 555.122, 555.123...

27 CFR 555.127 - Daily summary of magazine transactions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... each magazine. Not later than the close of the next business day, each licensee and permittee shall... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Daily summary of magazine....127 Daily summary of magazine transactions. In taking the inventory required by §§ 555.122, 555.123...

Temporal changes in blood product usage in preterm neonates born at less than 30 weeks' gestation in Canada.

PubMed

Keir, Amy K; Yang, Junmin; Harrison, Adele; Pelausa, Ermelinda; Shah, Prakesh S

2015-06-01

Knowledge of neonatal transfusion practices remains limited to local cohorts or survey-based studies. This study evaluated the pattern and temporal changes in the types and frequency of blood product use among preterm neonates born at less than 30 weeks' gestation in Canada. A retrospective cohort study of preterm neonates born at less than 30 weeks' gestation and admitted to participating neonatal intensive care units in the Canadian Neonatal Network from 2004 to 2012 was conducted to evaluate blood product usage. The temporal change in red blood cell (RBC) use was evaluated by dividing the study period into three epochs: 2004 to 2006, 2007 to 2009, and 2010 to 2012. Of 14,868 eligible neonates admitted to participating units in Canada during the overall study period, 8252 (56%) received RBCs, 2151 (15%) platelets, 1556 (11%) fresh-frozen plasma, 915 (6%) albumin, and 302 (2%) cryoprecipitate. Temporal evaluation over three epochs revealed a trend toward fewer RBC transfusions among neonates born at 26 to 29 weeks' gestation (p = <0.01-0.04) but use remained unchanged or increased for neonates born at 23 to 25 weeks' gestation (p = 0.02-0.54). Blood product use remains at a very high frequency in preterm neonates born at less than 30 weeks' gestation. Evolutionary practice changes and relative high tolerance for anemia may be associated with a reduction in RBC usage in recent years in neonates born at at least 26 weeks' gestation. This contrasts with the ongoing higher usage of blood products observed at extremely low gestational ages. © 2015 AABB.

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form

PubMed Central

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B.; Lee-Kim, Youngna; Shah, Mona D.

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%. PMID:29333497

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form.

PubMed

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B; Lee-Kim, Youngna; Shah, Mona D

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%.

27 CFR 31.160 - Monthly summary report.

Code of Federal Regulations, 2010 CFR

2010-04-01

... documents regarding the receipt and disposition of distilled spirits that have a direct role in determining... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Monthly summary report. 31.160 Section 31.160 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU...

Prehospital blood product transfusion by U.S. army MEDEVAC during combat operations in Afghanistan: a process improvement initiative.

PubMed

Malsby, Robert F; Quesada, Jose; Powell-Dunford, Nicole; Kinoshita, Ren; Kurtz, John; Gehlen, William; Adams, Colleen; Martin, Dustin; Shackelford, Stacy

2013-07-01

U.S. Army flight medics performed a process improvement initiative of 15 blood product transfusions on select Category A (Urgent) helicopter evacuation casualties meeting approved clinical indications for transfusion. These transfusions were initiated from point of injury locations aboard MEDEVAC aircraft originating from one of two locations in southern Afghanistan. All flight medics executing the transfusions were qualified through a standardized and approved program of instruction, which included day and night skills validation, and a 90% or higher written examination score. There was no adverse reaction or out-of-standard blood product temperature despite hazardous conditions and elevated cabin temperatures. All casualties within a 10-minute flight time who met clinical indications were transfused. Utilization of a standard operating procedure with strict handling and administration parameters, a rigorous training and qualification program, an elaborate cold chain system, and redundant documentation of blood product units ensured that flight medic initiated transfusions were safe and effective. Research study is needed to refine the indications for prehospital blood transfusion and to determine the effect on outcomes in severely injured trauma patients. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

From blood transfusion to patient blood management: a new paradigm for patient care and cost assessment of blood transfusion practice.

PubMed

Leahy, M F; Mukhtar, S A

2012-03-01

The ageing population in developed countries, including Australia, is putting increasing demands on blood transfusion services. With a falling donor pool there is likely to be a shortage of blood and blood products in the next 20 to 30 years unless there are significant changes in medical practice. The National Health and Medical Research Council/Australasian Society of Blood Transfusion Clinical Practice Guidelines on the Use of Blood Components from 2001 are being redeveloped by the National Health and Medical Research Council/Australian and New Zealand Society of Blood Transfusion as evidence-based patient-focused Patient Blood Management guidelines with the aim of improving patient outcomes by reducing inappropriate blood and blood product use and targeting therapies for improving the management of anaemia and coagulopathies. © 2012 The Authors. Internal Medicine Journal © 2012 Royal Australasian College of Physicians.

Blood and War

PubMed Central

Hedley-Whyte, John; Milamed, Debra R

2010-01-01

SUMMARY In 1894 Ulsterman and pathologist Almroth Wright described the citation of blood. Twenty-one years later it was introduced into wartime and clinical practice. Harvard Medical School had a large part in providing Colonel Andrew Fullerton, later Professor of Surgery, Queen's Belfast, with the intellectual and practical help for the Allies to deploy blood on the post-Somme Western Front and in Salonika. The key investigators and clinicians were Americans and Canadians who with Fullerton and Wright instructed the Allies. The key enablers were two Harvard-trained surgeons surnamed Robertson—Oswald H. (“Robby”) and L. Bruce (no relation). Physician Roger I. Lee of Harvard, surgeon George W Crile of Cleveland, Peyton Rous of the Rockefeller Institute and Richard Lewisohn of Mount Sinai Hospital, both located in the Upper East Side of New York City, played key roles. By Armistice in 1918, indirect citrated nutrient-enhanced blood transfusion was widely used by the Allies. Geoffrey Keynes was taught the techniques of blood transfusion by Dr. Benjamin Harrison Alton of Harvard at a Casualty Clearing Station near Albert at the time of the Battle of Passchendaele. Professor “Robby” Robertson, DSO, Sir Geoffrey Keynes and Sir Thomas Houston established blood banking. PMID:22375087

Efficacy of tranexamic acid in reducing allogeneic blood products in adolescent idiopathic scoliosis surgery.

PubMed

Sui, Wen-yuan; Ye, Fang; Yang, Jun-lin

2016-04-27

Adolescent idiopathic scoliosis (AIS) surgery usually require prolonged operative times with extensive soft tissue dissection and significant perioperative blood loss, and allogeneic blood products are frequently needed. Methods to reduce the requirement for transfusion would have a beneficial effect on these patients. Although many previous studies have revealed the efficacy of tranexamic acid (TXA) in spinal surgery, there is still a lack of agreement concerning the reduction of both blood loss and transfusion requirements of large dose tranexamic acid (TXA) in surgery for adolescent idiopathic scoliosis (AIS). The objective of this study was to elevate the efficacy and safety of a large dose tranexamic acid (TXA) in reducing transfusion requirements of allogeneic blood products in adolescent idiopathic scoliosis (AIS) surgery using a retrospective study designed with historical control group. One hundred thirty seven consecutive AIS patients who underwent surgery treatment with posterior spinal pedicle systems from August 2011 to March 2015 in our scoliosis center were retrospectively reviewed. Patients were divided into two groups, the TXA group and the historical recruited no TXA group (NTXA). Preoperative demographics, radiographic parameters, operative parameters, estimated blood loss (EBL), total irrigation fluid, number of patients requiring blood transfusion, mean drop of Hb (Pre-op Hb-Post-op Hb), haematocrit pre and post-surgery, mean volume of blood transfusion, hospitalization time, and adverse effect were recorded and compared. All the patients were successfully treated with satisfied clinical and radiographic outcomes. There were 71 patients in the TXA group and 66 patients in the NTXA group. The preoperative demographics were homogeneity between two groups (P > 0.05). There were no significant difference in average operative time between two groups (209 min vs 215 min, p >0.05). Number of patients in the TXA group showed a significant decrease in

Cloud Compute for Global Climate Station Summaries

NASA Astrophysics Data System (ADS)

Baldwin, R.; May, B.; Cogbill, P.

2017-12-01

Global Climate Station Summaries are simple indicators of observational normals which include climatic data summarizations and frequency distributions. These typically are statistical analyses of station data over 5-, 10-, 20-, 30-year or longer time periods. The summaries are computed from the global surface hourly dataset. This dataset totaling over 500 gigabytes is comprised of 40 different types of weather observations with 20,000 stations worldwide. NCEI and the U.S. Navy developed these value added products in the form of hourly summaries from many of these observations. Enabling this compute functionality in the cloud is the focus of the project. An overview of approach and challenges associated with application transition to the cloud will be presented.

Cultured blood versus donated blood: long-run perspectives of the economy of blood.

PubMed

Mercier Ythier, Jean

2015-01-01

Recent advances of fundamental research on the in vitro generation of red blood cells (RBCs) from hematopoietic stem cells in the laboratory open new possibilities of the utilization of cultured RBCs in transfusion medicine. We study the economic challenge of the setup and development of the mass industrial production of RBCs in mature transfusion organizations. We argue that: (i) RBC manufacturing could be set up and developed in the short-medium run for the treatment of the small proportion of transfused patients who have a rare blood type or are alloimmunized against blood antigens; (ii) manufactured RBCs could substitute for donated RBCs in the long run if the physical productivity of RBC engineering technology approaches that of bone marrow.

Prospective change control analysis of transfer of platelet concentrate production from a specialized stem cell transplantation unit to a blood transfusion center.

PubMed

Sigle, Joerg-Peter; Medinger, Michael; Stern, Martin; Infanti, Laura; Heim, Dominik; Halter, Joerg; Gratwohl, Alois; Buser, Andreas

2012-01-01

Specialized centers claim a need for blood component production independent from the general blood transfusion services. We performed a prospective change control analysis of the transfer of platelet (PLT) production for hematological patients at the University Hospital Basel from the Department of Hematology to the Blood Transfusion Centre, Swiss Red Cross, Basel in February 2006. We wanted to demonstrate that neither quality nor transfusion outcome was affected. Production quantity and efficiency, product quality and transfusion outcome were systematically recorded. A 2-year pretransfer period was compared to a 2 year post-transfer period. After transfer production quantity at the Blood Transfusion Centre increased from 4,483 to 6,190 PLT concentrates. Production efficiency increased with a significant decrease in the rate of expired products (18% vs. 8%; P < 0.001). Product quality showed a slight decrease in median PLT count per unit (2.84 vs. 2.75 × 10(11); P < 0.001) and a slight increase in mean storage time prior to transfusion (3.18 vs. 3.30 days; P < 0.001). Transfusion outcome measured as median corrected count increment one hour post-transfusion (10.5 vs. 10.7; P = 0.3) and the rate of patients with inadequate post-transfusion increment (31.5% vs. 32.1%; P = 0.6) did not differ. Supply and quality of PLT products was maintained after the transfer of PLT production to the Blood Transfusion Centre. An optimization of the supply chain process with markedly decreased expiration rates was achieved. These results argue against the need of specialized PLT production sites for selected patient groups. Copyright © 2012 Wiley Periodicals, Inc.

Effects of three blood derived products on equine corneal cells, an in vitro study.

PubMed

Rushton, J O; Kammergruber, E; Tichy, A; Egerbacher, M; Nell, B; Gabner, S

2018-05-01

Despite advances in therapy of corneal ulcerative diseases in horses, a vast number of cases require surgical intervention, due to poor response to treatment. Topical application of serum has been used for many years, based on its anticollagenolytic properties and the presence of growth factors promoting corneal wound healing. However, although other blood derived products i.e. platelet rich plasma (PRP), plasma rich in growth factors (PRGF) have been widely used in equine orthopaedics and in human ophthalmology, no reports of the effects of these blood derived products exist in equine ophthalmology. To determine in vitro effects of PRGF and PRP on equine corneal cells compared with serum. Prospective controlled cohort study. Blood from 35 healthy horses was used to produce serum, PRGF (Endoret ® ), and PRP (E-PET™). Limbal- and stromal cells were isolated from healthy corneas of six horses and treated with 20% serum, 20% PRGF or 20% PRP. Proliferation rates and migration capacity were analysed in single cell cultures as well as co-culture systems. Cell proliferation increased with PRP treatment, remained constant in PRGF treated cells, and declined upon serum treatment over a period of 48 h. Migration capacity was significantly enhanced with PRP treatment, compared with PRGF treatment. Intact leucocytes, mainly eosinophils, were only detected in PRP. Due to the study design use of autologous blood products on corneal cells was not possible. The results demonstrate beneficial effects of PRP on proliferation as well as migration capacity of equine corneal cells in vitro. In vivo studies are warranted to determine further beneficial effects of PRP in horses with corneal ulcers. © 2017 EVJ Ltd.

Blood Flow Modulation of Vascular Dynamics

PubMed Central

Lee, Juhyun; Sevag Packard, René R.; Hsiai, Tzung K.

2015-01-01

Purpose of review Blood flow is intimately linked with cardiovascular development, repair, and dysfunction. The current review will build on the fluid mechanical principle underlying hemodynamic shear forces, mechanotransduction, and metabolic effects. Recent findings Pulsatile flow produces both time- (∂τ /∂t)and spatial-varying shear stress (∂τ /∂x) to modulate vascular oxidative stress and inflammatory response with pathophysiological significance to atherosclerosis. The characteristics of hemodynamic shear forces; namely, steady laminar (∂τ /∂t= 0), pulsatile (PSS: unidirectional forward flow), and oscillatory shear stress (OSS: bidirectional with a near net 0 forward flow) modulate mechano-signal transduction to influence metabolic effects on vascular endothelial function. Atheroprotective PSS promotes anti-oxidant, anti-inflammatory, and anti-thrombotic responses, whereas atherogenic OSS induces NADPH oxidase–JNK signaling to increase mitochondrial superoxide production, protein degradation of manganese superoxide dismutase (MnSOD), and post-translational protein modifications of LDL particles in the disturbed flow-exposed regions of vasculature. In the era of tissue regeneration, shear stress has been implicated in re-activation of developmental genes; namely, Wnt and Notch signaling, for vascular development and repair. Summary Blood flow imparts a dynamic continuum from vascular development to repair. Augmentation of PSS confers atheroprotection and re-activation of developmental signaling pathways for regeneration. PMID:26218416

Economic analysis of blood product transfusions according to the treatment of acute myeloid leukemia in the elderly.

PubMed

Cannas, G; Fattoum, J; Boukhit, M; Thomas, X

2015-01-01

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). Low-intensity treatments (low-dose cytarabine, hypomethylating agents) have the potential to reduce transfusion dependence, and improve health-related quality of life. We assessed the cost-effectiveness of treatment types regarding blood product transfusions in a cohort of 214 AML patients aged ≥ 70 years. Analyzes did not indicate any significant overall survival (OS) advantage of intensive chemotherapy comparatively to low-intensity treatment. The difference was significant when compared to best supportive care (BSC) (P<0.0001). Blood products transfusion cost per patient was 1.3 times lower with low-intensity therapy and 2.7 times lower with BSC than with intensive chemotherapy. Mean transfusion cost per patient according to OS varied from 2.4 to 1.3 times less with low-intensity treatment comparatively to intensive chemotherapy for patients having OS ≤ 13.3 months. Costs varied from 3.5 to 2.6 times less with BSC comparatively to intensive chemotherapy. In contrast, mean transfusion costs were comparable among treatments for patients with OS>13.3 months. Low-intensity treatments represent a cost-effective alternative to BSC and require a reduced number of transfused blood products comparatively to intensive chemotherapy, while OS was not significantly different. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

[Analysis of productivity, quality and cost of first grade laboratories: blood biometry].

PubMed

Avila, L; Hernández, P; Cruz, A; Zurita, B; Terres, A M; Cruz, C

1999-04-01

Assessment of productivity, quality and production costs and determination of the efficiency of top grade clinical laboratories in Mexico. Ten laboratories were selected from among the total number (52) existing in Mexico City, and the Donabedian model of structure, process and results were applied. Blood count was selected as a tracer. The principal problems found were: inadequate distribution of trained human resources, poor glass material, inadequate analytic process and low productivity. These factors are reflected in the unit costs, which exceed reference laboratory costs by 200%. Only 50% of the laboratories analyzed generate reliable results. Only 20% of the laboratories studied operate efficiently. To solve the problems identified requires integral strategies at different levels. A specific recomendation for the improvement of quality and productivity is an assessment of the cost/benefit of creating a central laboratory and using the remaining sites exclusively for the collection of samples.

Sequential production of leukaemia inhibitory factor by blood cell culture in patients with ARDS.

PubMed

Gruson, D; Hilbert, G; Juzan, M; Taupin, J L; Coulon, V; Moreau, J F; Gualde, N; Gbikpi-Benissan, G

1998-04-01

Leukaemia inhibitory factor (LIF) is a polyfunctional cytokine integrated in cytokine networks and its concentration has been shown to be elevated in bronchoalveolar lavage fluid of patients with the acute respiratory distress syndrome (ARDS). The aim of our study was to evaluate the production of LIF by culturing blood cells from patients with ARDS. 8 patients with ARDS, 8 patients with pneumonia and 5 healthy subjects. The blood samples were taken on day 1 after onset of ARDS. LIF was measured, in the cell-free supernatant, with an enzyme-linked immunosorbent assay after 24 h, 48 h and 72 h of blood cell culture. LIF was detectable in some patients in the ARDS group: at i) at 24 h and 48 h: in 2 patients ii) at 72 h in 4/5 patients (140 +/- 231 pg/ml). Only in the 4 patients in whom LIF was measured at 72 h was ARDS associated with the multiple organ dysfunction syndrome. Furthermore, among the 5 patients with ARDS who subsequently died, 4 had a detectable LIF. We have observed that LIF was produced only in ARDS, but not in all patients. The production of LIF seems to be a good indicator of the severity of ARDS. These preliminary results must be confirmed by a larger study.

In vitro production of GHB in blood and serum samples under various storage conditions.

PubMed

Zörntlein, S W; Kopp, A; Becker, J; Kaufmann, T J; Röhrich, J; Urban, R

2012-01-10

The in vitro production of GHB was observed in freshly collected, untreated whole blood samples using glass BD-Vacutainers and polypropylene S-monovettes. GHB concentrations were determined daily over a period of one week and after 3, 6 and 9 weeks again. Furthermore, the GHB concentration in 40 untreated random whole blood samples stored at 4°C for a longer period of time (10 samples 12 month, 10 samples 24 month and 20 samples 36 month) was also determined. For comparison, the in vitro production of GHB in freshly collected and prepared serum samples was observed. GHB serum concentrations were determined three times over a period of one week and once again after six weeks. Sample preparation was performed by means of methanolic extraction following the precipitation of whole blood and serum samples. A methanolic standard calibration was done in a low range of 0.005-0.1 μg/mL (LOD: 0.004, LLOQ: 0.013). For quantification a spiked blood bank serum with a determined GHB concentration of 0.09 μg/mL was used. Corrected calibrations in the range of 0.09-5.09 μg/mL were used (LOD: 0.08 μg/mL, LLOQ: 0.30 μg/mL), recovery: 91.3% (high level: 4.09 μg/mL) 50.5% (low level: 0.19 μg/mL). Relevant elevation of GHB was observed in all whole blood samples stored in liquid form (4°C or room temperature). In two of the 40 whole blood samples stored over a longer period of time at 4°C, GHB concentrations in the range of 13 μg/mL were even determined. These findings constitute grounds for caution. Even a GHB cut-off level of 5 μg/mL cannot be considered as "absolutely positive" proof of a case of exogenous administration, at least in untreated liquid blood samples in long time storage. However, no significant elevations of GHB were otherwise observed in any of the serum samples independently of storage temperature nor in the whole blood samples that were frozen for storage. The results suggest that the cut-off for exogenous GHB of 5 μg/mL could be lowered significantly

Headspace gas chromatography of volatile lipid peroxidation products from human red blood cell membranes.

PubMed

Frankel, E N; Tappel, A L

1991-06-01

An improved headspace capillary gas chromatographic (GC) method was developed to measure the oxidative susceptibility of human red blood cell (RBC) membranes. This method analyzed volatile peroxidation products of both n-6 (hexanal and pentane) and n-3 (propanal) polyunsaturated fatty acids. Oxidative susceptibility tests were standardized by incubating in a sealed 10-mL headspace bottle 0.25 or 1 mL of human RBC membrane in 40 mM phosphate buffer for 1 hr at 37 degrees C with a mixture of Fe++, ascorbic acid and H2O2. Sodium dodecyl sulfate increased significantly the amount of hexanal measured by headspace GC. By this standard headspace method, in one series of red blood cell membranes (RBCM) samples a four-fold variation in oxidative susceptibility was observed in RBCM from blood freshly drawn from six healthy subjects. In another series of RBCM samples a sixteen-fold variation in oxidative susceptibility was noted in frozen RBCM from blood freshly drawn from five healthy subjects. Correlation between hexanal formation and polyunsaturated fatty acids (PUFA) depletion provided good evidence that under these standard conditions hexanal is exclusively derived from the oxidation of arachidonic acid. Hydroperoxides of arachidonic acid are more readily formed and decomposed than those of linoleic acid in the presence of Fe++, ascorbic acid and H2O2 to produce hexanal as the main product that can be readily analyzed by headspace GC. This method may provide a useful tool to study susceptibility toward lipid peroxidative damage in human RBC membranes.

Osmolality - blood

MedlinePlus

... High blood sugar level ( hyperglycemia ) High level of nitrogen waste products in the blood ( uremia ) High sodium ... 2013:832-833. Verbalis JG. Disorders of water balance. In: Skorecki K, Chertow GM, Marsden PA, Taal ...

SUMMARY OF DISCUSSION SESSIONS: SYMPOSIUM ON LEAD-BLOOD PRESSURE RELATIONSHIPS

EPA Science Inventory

The International Symposium on Lead-Blood Pressure Relationships was held in Chapel Hill, NC, April 27-29, 1987. The program was structured so as to first present an overview of theories and findings in the general area of human hypertension and then to have speakers review the e...

An Adaptive Association Test for Multiple Phenotypes with GWAS Summary Statistics.

PubMed

Kim, Junghi; Bai, Yun; Pan, Wei

2015-12-01

We study the problem of testing for single marker-multiple phenotype associations based on genome-wide association study (GWAS) summary statistics without access to individual-level genotype and phenotype data. For most published GWASs, because obtaining summary data is substantially easier than accessing individual-level phenotype and genotype data, while often multiple correlated traits have been collected, the problem studied here has become increasingly important. We propose a powerful adaptive test and compare its performance with some existing tests. We illustrate its applications to analyses of a meta-analyzed GWAS dataset with three blood lipid traits and another with sex-stratified anthropometric traits, and further demonstrate its potential power gain over some existing methods through realistic simulation studies. We start from the situation with only one set of (possibly meta-analyzed) genome-wide summary statistics, then extend the method to meta-analysis of multiple sets of genome-wide summary statistics, each from one GWAS. We expect the proposed test to be useful in practice as more powerful than or complementary to existing methods. © 2015 WILEY PERIODICALS, INC.

Impact of blood products on platelet function in patients with traumatic injuries: a translational study.

PubMed

Henriksen, Hanne Hee; Grand, Alexandra G; Viggers, Sandra; Baer, Lisa A; Solbeck, Sacha; Cotton, Bryan A; Matijevic, Nena; Ostrowski, Sisse R; Stensballe, Jakob; Fox, Erin E; Chen, Tzu-An; Holcomb, John B; Johansson, Pär I; Cardenas, Jessica C; Wade, Charles E

2017-06-15

Reductions in platelet (PLT) count and function are associated with poor outcomes in trauma patients. We proposed to determine if patients expected to receive blood products have a decrease in PLT function higher than expected based on the reduction in PLT count, and if the reduction in function could be associated with the donor plasma/supernatant received. PLT count and function were measured on admission to the emergency department and intensive care unit in severely injured patients expected to receive a transfusion. PLT function was measured by Multiplate aggregometry in response to five agonists. Function was corrected for alterations in count. In vitro studies were conducted in the blood of normal subjects to assess the effect of dilutions with AB donor plasma on PLT function. Forty-six patients were enrolled, with 87% requiring a transfusion. Median Injury Severity Score was 23 (13, 29) and mortality 15%. PLT count and function were decreased from emergency department to intensive care unit admission by 25% and 58%, respectively. Decreases in function persisted after adjustment for count. Patients requiring large volumes of blood products had reductions in function that were disproportionately greater. Reductions in PLT function were greatest after transfusion of PLTs. In in vitro studies with a 30% dilution by autologous plasma caused a relational reduction in function, whereas allogenic plasma resulted in greater decreases that were highly variable between donors. Within hours of injury a decrease in both PLT count and function occurs, that is aggravated with the administration of blood products, with transfusion of PLTs showing the greatest effect. The effect on PLT function of allogenic transfused plasma appears to be highly donor related. Copyright © 2017 Elsevier Inc. All rights reserved.

Relationship between milk production and some blood constituents in Egyptian Baladi goats.

PubMed

Hassan, G A; el-Nouty, F D; Samak, M A; Salem, M H

1986-01-01

Under the conditions of a high ambient temperature and the lack of green fodder goats are very important for milk production. During 16 weeks of lactation period, the milk yield of 10 Baladi goats was 55 kg. The amount of milk exhibited a positive relation to the globulin and glucose content of the blood. There was a highly negative correlation with the albumin content and the number of leucocytes.

Evaluation of Stem Cell-Derived Red Blood Cells as a Transfusion Product Using a Novel Animal Model.

PubMed

Shah, Sandeep N; Gelderman, Monique P; Lewis, Emily M A; Farrel, John; Wood, Francine; Strader, Michael Brad; Alayash, Abdu I; Vostal, Jaroslav G

2016-01-01

Reliance on volunteer blood donors can lead to transfusion product shortages, and current liquid storage of red blood cells (RBCs) is associated with biochemical changes over time, known as 'the storage lesion'. Thus, there is a need for alternative sources of transfusable RBCs to supplement conventional blood donations. Extracorporeal production of stem cell-derived RBCs (stemRBCs) is a potential and yet untapped source of fresh, transfusable RBCs. A number of groups have attempted RBC differentiation from CD34+ cells. However, it is still unclear whether these stemRBCs could eventually be effective substitutes for traditional RBCs due to potential differences in oxygen carrying capacity, viability, deformability, and other critical parameters. We have generated ex vivo stemRBCs from primary human cord blood CD34+ cells and compared them to donor-derived RBCs based on a number of in vitro parameters. In vivo, we assessed stemRBC circulation kinetics in an animal model of transfusion and oxygen delivery in a mouse model of exercise performance. Our novel, chronically anemic, SCID mouse model can evaluate the potential of stemRBCs to deliver oxygen to tissues (muscle) under resting and exercise-induced hypoxic conditions. Based on our data, stem cell-derived RBCs have a similar biochemical profile compared to donor-derived RBCs. While certain key differences remain between donor-derived RBCs and stemRBCs, the ability of stemRBCs to deliver oxygen in a living organism provides support for further development as a transfusion product.

Notifying patients exposed to blood products associated with Creutzfeldt-Jakob disease: integrating science, legal duties and ethical mandates

PubMed Central

Caulfield, T; Dossetor, J; Boshkov, L; Hannon, J; Sawyer, D; Robertson, G

1997-01-01

The issue of notifying people who have been exposed to blood products that have been associated with Creutzfeldt-Jakob disease (CJD) has arisen at a time when the Canadian blood system is under intense scrutiny. As a result, the Canadian Red Cross Society issued a recommendation to health care institutions that recipients of CJD-associated blood products be identified, notified and counselled. Although Canadian jurisprudence in the realm of informed consent may support a policy of individual notification, a review of the scientific evidence and the applicable ethical principles arguably favours a policy of a more general public notification. Indeed, situations such as this require a unique approach to the formation of legal and ethical duties, one that effectively integrates all relevant factors. As such, the authors argue that individual notification is currently not justified. Nevertheless, if a system of general notification is implemented (e.g., through a series of public health announcements), it should provide, for people who wish to know, the opportunity to find out whether they were given CJD-associated products. PMID:9371070

Concentrations of pentosidine, an advanced glycation end-product, in umbilical cord blood.

PubMed

Tsukahara, Hirokazu; Ohta, Naoko; Sato, Shuko; Hiraoka, Masahiro; Shukunami, Ken-Ichi; Uchiyama, Mayumi; Kawakami, Hisako; Sekine, Kyouichi; Mayumi, Mitsufumi

2004-07-01

Advanced glycation end-products (AGEs) are formed over several weeks to months by non-enzymatic glycation and oxidation ("glycoxidation") reactions between carbohydrate-derived carbonyl groups and protein amino groups, known as the Maillard reaction. Pentosidine is one of the best-characterized AGEs and is accepted as a satisfactory marker for glycoxidation in vivo. The present study was intended to measure pentosidine concentrations in umbilical cord blood from newborns with various gestational ages using our recently established high-performance liquid chromatography method [Tsukahara, H. et al. (2003) Pediatr. Res. 54, 419-424]. Our study demonstrates, for the first time, that pentosidine is detected in most of the umbilical blood samples. This study also shows that the umbilical blood concentrations of pentosidine are considerably lower than normal adult values, but that they increase with gestation progression and fetal growth. Umbilical pentosidine concentrations were significantly elevated in newborns of mothers with preeclampsia compared to those of mothers without preeclampsia. We conclude that accumulation of AGEs and oxidative stress occurs in fetal tissues and organs in utero at the early stage of human life and that their accumulation is augmented in the maternal preeclampsic condition.

IRIS TOXICOLOGICAL REVIEW AND SUMMARY ...

EPA Pesticide Factsheets

EPA's assessment of the noncancer health effects and carcinogenic potential of Beryllium was added to the IRIS database in 1998. The IRIS program is updating the IRIS assessment for Beryllium. This update will incorporate health effects information published since the last assessment was prepared as well as new risk assessment methods. The IRIS assessment for Beryllium will consist of an updated Toxicological Review and IRIS Summary. The Toxicological Review is a critical review of the physicochemical and toxicokinetic properties of the chemical and its toxicity in humans and experimental systems. The assessment will present reference values for noncancer effects of Beryllium (RfD and RfC) and a cancer assessment. The Toxicological Review and IRIS Summary will be subject to internal peer consultation, Agency and Interagency review, and external scientific peer review. The final products will constitute the Agency's opinion on the toxicity of Beryllium. Beryllium is a light alkaline earth metal used in metal alloys and in high-performance products in the metallurgical, aerospace, and nuclear industries. According to the Superfund database, beryllium is found in over 300 NPL sites

Quality Improvement Methodologies Increase Autologous Blood Product Administration

PubMed Central

Hodge, Ashley B.; Preston, Thomas J.; Fitch, Jill A.; Harrison, Sheilah K.; Hersey, Diane K.; Nicol, Kathleen K.; Naguib, Aymen N.; McConnell, Patrick I.; Galantowicz, Mark

2014-01-01

Abstract: Whole blood from the heart–lung (bypass) machine may be processed through a cell salvaging device (i.e., cell saver [CS]) and subsequently administered to the patient during cardiac surgery. It was determined at our institution that CS volume was being discarded. A multidisciplinary team consisting of anesthesiologists, perfusionists, intensive care physicians, quality improvement (QI) professionals, and bedside nurses met to determine the challenges surrounding autologous blood delivery in its entirety. A review of cardiac surgery patients’ charts (n = 21) was conducted for analysis of CS waste. After identification of practices that were leading to CS waste, interventions were designed and implemented. Fishbone diagram, key driver diagram, Plan–Do–Study–Act (PDSA) cycles, and data collection forms were used throughout this QI process to track and guide progress regarding CS waste. Of patients under 6 kg (n = 5), 80% had wasted CS blood before interventions, whereas those patients larger than 36 kg (n = 8) had 25% wasted CS before interventions. Seventy-five percent of patients under 6 kg who had wasted CS blood received packed red blood cell transfusions in the cardiothoracic intensive care unit within 24 hours of their operation. After data collection and didactic education sessions (PDSA Cycle I), CS blood volume waste was reduced to 5% in all patients. Identification and analysis of the root cause followed by implementation of education, training, and management of change (PDSA Cycle II) resulted in successful use of 100% of all CS blood volume. PMID:24783313

21 CFR 864.9050 - Blood bank supplies.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood bank supplies. 864.9050 Section 864.9050...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9050 Blood bank supplies. (a) Identification. Blood bank supplies are general...

21 CFR 864.9050 - Blood bank supplies.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood bank supplies. 864.9050 Section 864.9050...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9050 Blood bank supplies. (a) Identification. Blood bank supplies are general...

21 CFR 864.9050 - Blood bank supplies.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood bank supplies. 864.9050 Section 864.9050...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9050 Blood bank supplies. (a) Identification. Blood bank supplies are general...

The U.S. Geological Survey's Earthquake Summary Posters: A GIS-based Education and Communication Product for Presenting Consolidated Post-Earthquake Information

NASA Astrophysics Data System (ADS)

Tarr, A.; Benz, H.; Earle, P.; Wald, D. J.

2003-12-01

Earthquake Summary Posters (ESP's), a new product of the U.S. Geological Survey's Earthquake Program, are produced at the National Earthquake Information Center (NEIC) in Golden. The posters consist of rapidly-generated, GIS-based maps made following significant earthquakes worldwide (typically M>7.0, or events of significant media/public interest). ESP's consolidate, in an attractive map format, a large-scale epicentral map, several auxiliary regional overviews (showing tectonic and geographical setting, seismic history, seismic hazard, and earthquake effects), depth sections (as appropriate), a table of regional earthquakes, and a summary of the reional seismic history and tectonics. The immediate availability of the latter text summaries has been facilitated by the availability of Rapid, Accurate Tectonic Summaries (RATS) produced at NEIC and posted on the web following significant events. The rapid production of ESP's has been facilitated by generating, during the past two years, regional templates for tectonic areas around the world by organizing the necessary spatially-referenced data for the map base and the thematic layers that overlay the base. These GIS databases enable scripted Arc Macro Language (AML) production of routine elements of the maps (for example background seismicity, tectonic features, and probabilistic hazard maps). However, other elements of the maps are earthquake-specific and are produced manually to reflect new data, earthquake effects, and special characteristics. By the end of this year, approximately 85% of the Earth's seismic zones will be covered for generating future ESP's. During the past year, 13 posters were completed, comparable to the yearly average expected for significant earthquakes. Each year, all ESPs will be published on a CD in PDF format as an Open-File Report. In addition, each is linked to the special event earthquake pages on the USGS Earthquake Program web site (http://earthquake.usgs.gov). Although three formats

Enumeration of residual white blood cells in leukoreduced blood products: Comparing flow cytometry with a portable microscopic cell counter.

PubMed

Castegnaro, Silvia; Dragone, Patrizia; Chieregato, Katia; Alghisi, Alberta; Rodeghiero, Francesco; Astori, Giuseppe

2016-04-01

Transfusion of blood components is potentially associated to the risk of cell-mediated adverse events and current guidelines require a reduction of residual white blood cells (rWBC) below 1 × 10(6) WBC/unit. The reference method to enumerate rare events is the flow cytometry (FCM). The ADAM-rWBC microscopic cell counter has been proposed as an alternative: it measures leukocytes after their staining with propidium iodide. We have tested the Adam-rWBC for the ability to enumerate rWBC in red blood cells and concentrates. We have validated the flow cytometry (FCM) for linearity, precision accuracy and robustness and then the ADAM-rWBC results have been compared with the FCM. Our data confirm the linearity, accuracy, precision and robustness of the FCM. The ADAM-rWBC has revealed an adequate precision and accuracy. Even if the Bland-Altman analysis of the paired data has indicated that the two systems are comparable, it should be noted that the rWBC values obtained by the ADAM-rWBC were significantly higher compared to FCM. In conclusion, the Adam-rWBC cell counter could represent an alternative where FCM technology expertise is not available, even if the risk that borderline products could be misclassified exists. Copyright © 2015 Elsevier Ltd. All rights reserved.

Blood Product Utilization Among Trauma and Nontrauma Massive Transfusion Protocols at an Urban Academic Medical Center.

PubMed

Patel, Eshan U; Ness, Paul M; Marshall, Christi E; Gniadek, Thomas; Efron, David T; Miller, Peter M; Zeitouni, Joseph A; King, Karen E; Bloch, Evan M; Tobian, Aaron A R

2017-09-01

Hospital-wide massive transfusion protocols (MTPs) primarily designed for trauma patients may lead to excess blood products being prepared for nontrauma patients. This study characterized blood product utilization among distinct trauma and nontrauma MTPs at a large, urban academic medical center. A retrospective study of blood product utilization was conducted in patients who required an MTP activation between January 2011 and December 2015 at an urban academic medical center. Trauma MTP containers included 6 red blood cell (RBC) units, 5 plasma units, and 1 unit of apheresis platelets. Nontrauma MTP containers included 6 RBC and 3 plasma units. There were 334 trauma MTP activations, 233 nontrauma MTP activations, and 77 nontrauma MTP activations that subsequently switched to a trauma MTP ("switched activations"). All nontrauma MTP activations were among bleeding patients who did not have a traumatic injury (100% [233/233]). Few patients with a nontrauma activation required ad hoc transfusion of RBC units (1.3% [95% confidence interval {CI}, 0.3%-3.7%]) or plasma (3.4% [95% CI, 1.5%-6.7%]), and only 45.5% (95% CI, 39.0%-52.1%) required ad hoc transfusion of apheresis platelets. Compared to trauma and switched activations, nontrauma activations transfused a lower median number of RBC, plasma, and apheresis platelet units (P < .001 for all comparisons). There was also a lower median number of prepared but unused plasma units for nontrauma activations (3; [interquartile range {IQR}, 3-5]) compared to trauma (7; [IQR, 5-10]; P < .001) and switched activations (8; [IQR, 5-11]; P < .001). The median number of unused apheresis platelet units was 1 (IQR, 1-2) for trauma activations and 0 (IQR, 0-1) for switched activations. There was a high proportion of trauma and switched activations in which all of the prepared apheresis platelet units were unused (28.1% [95% CI, 23.4%-33.3%] and 9.1% [95% CI, 3.7%-17.8%], respectively). The majority of initial nontrauma MTP activations

Thymus cells in myasthenia gravis selectively enhance production of anti-acetylcholine-receptor antibody by autologous blood lymphocytes

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

Newsom-Davis, J.; Willcox, N.; Calder, L.

1981-11-26

We investigated the role of the thymus in 16 patients with myasthenia gravis without thymoma by studying the production of anti-acetylcholine-receptor antibody by thymic and blood lymphocytes cultured alone or together. In 10 responders (with the highest receptor-antibody titers in their plasma), cultured thymic cells spontaneously produced measurable receptor antibody. Receptor-antibody production by autologous blood lymphocytes was enhanced by the addition of responder's thymic cells, irradiated to abrogate antibody production and suppression (P<0.01). This enhancement was greater and more consistent than that by pokeweed mitogen; it depended on viable thymic cells, appeared to be selective for receptor antibody, and correlatedmore » with the ratio of thymic helper (OKT4-positive or OKT4+) to suppressor (OKT8+) T cells (P<0.01). These results suggest that myasthenic thymus contains cell-bound acetylcholine-receptor-like material or specific T cells (or both) that can aid receptor-antibody production. This may be relevant to the benefits of thymectomy in myasthenia and to the breakdown in self-tolerance in this and other autoimmune diseases.« less

Early Post-Operative Outcomes and Blood Product Utilization in Adult Cardiac Surgery- The Post Aprotinin Era

PubMed Central

DeSantis, Stacia; Toole, J. Matthew; Kratz, John M.; Uber, Walter E.; Wheat, Margaret J.; Stroud, Martha R.; Ikonomidis, John S.; Spinale, Francis G.

2011-01-01

Background Aprotinin was a commonly utilized pharmacological agent for homeostasis in cardiac surgery but was discontinued resulting in the extensive use of lysine analogues. This study tested the hypothesis that early post-operative adverse events and blood product utilization would affected in this post-aprotinin era. Methods/Results Adult patients (n=781) undergoing coronary artery bypass (CABG), valve replacement, or both from November 1, 2005-October 31, 2008 at a single institution were included. Multiple logistic regression modeling and propensity scoring were performed on 29 pre-operative and intra-operative variables in patients receiving aprotinin (n=325) or lysine analogues (n=456). The propensity adjusted relative risk (RR;95% confidence interval;CI) for the intra-operative use of packed red blood cells (RR:0.75;CI:0.57–0.99), fresh frozen plasma (RR:0.37;0.21–0.64), and cryoprecipitate (RR:0.06;CI:0.02–0.22) were lower in the aprotinin versus lysine analogue group (all p<0.05). The risk for mortality (RR:0.53;CI:0.16–1.79) and neurological events (RR:0.87;CI:0.35–2.18) remained similar between groups, whereas a trend for reduced risk for renal dysfunction was observed in the aprotinin group. Conclusions In the post-aprotinin era with the exclusive use of lysine analogues, the relative risk of early post-operative outcomes such as mortality and renal dysfunction have not improved, but the risk for the intra-operative use of blood products has increased. Thus, improvements in early post-operative outcomes have not been realized with the discontinued use of aprotinin, but rather increased blood product utilization has occurred with the attendant costs and risks inherent with this strategy. PMID:21911820

Plasma and Plasma Protein Product Transfusion: A Canadian Blood Services Centre for Innovation Symposium.

PubMed

Zeller, Michelle P; Al-Habsi, Khalid S; Golder, Mia; Walsh, Geraldine M; Sheffield, William P

2015-07-01

Plasma obtained via whole blood donation processing or via apheresis technology can either be transfused directly to patients or pooled and fractionated into plasma protein products that are concentrates of 1 or more purified plasma protein. The evidence base supporting clinical efficacy in most of the indications for which plasma is transfused is weak, whereas high-quality evidence supports the efficacy of plasma protein products in at least some of the clinical settings in which they are used. Transfusable plasma utilization remains composed in part of applications that fall outside of clinical practice guidelines. Plasma contains all of the soluble coagulation factors and is frequently transfused in efforts to restore or reinforce patient hemostasis. The biochemical complexities of coagulation have in recent years been rationalized in newer cell-based models that supplement the cascade hypothesis. Efforts to normalize widely used clinical hemostasis screening test values by plasma transfusion are thought to be misplaced, but superior rapid tests have been slow to emerge. The advent of non-vitamin K-dependent oral anticoagulants has brought new challenges to clinical laboratories in plasma testing and to clinicians needing to reverse non-vitamin K-dependent oral anticoagulants urgently. Current plasma-related controversies include prophylactic plasma transfusion before invasive procedures, plasma vs prothrombin complex concentrates for urgent warfarin reversal, and the utility of increased ratios of plasma to red blood cell units transfused in massive transfusion protocols. The first recombinant plasma protein products to reach the clinic were recombinant hemophilia treatment products, and these donor-free equivalents to factors VIII and IX are now being supplemented with novel products whose circulatory half-lives have been increased by chemical modification or genetic fusion. Achieving optimal plasma utilization is an ongoing challenge in the interconnected

Blood salvage produces higher total blood product costs in single-level lumbar spine surgery.

PubMed

Canan, Chelsea E; Myers, John A; Owens, Roger Kirk; Crawford, Charles H; Djurasovic, Mladen; Burke, Lauren O; Bratcher, Kelly R; McCarthy, Kathryn J; Carreon, Leah Y

2013-04-15

Retrospective review. To determine the incremental cost-effectiveness of cell saver for single-level posterior lumbar decompression and fusion (PLDF). Intraoperative cell salvage is used during surgery to reduce the need for perioperative allogeneic blood transfusion. Although the use of cell saver may be beneficial in certain circumstances, its utility has not been clearly established for the common procedure of an adult single-level PLDF. Randomly selected adult patients treated with a single-level PLDF between July 2010 and June 2011 at a single institution were identified. Patients who had a combined anterior and posterior approach were excluded. The final study sample for analysis consisted of 180 patients. Hospital records were reviewed to determine whether: (1) cell saver was available during surgery, (2) recovered autologous blood was infused, and (3) the patient received intra- or postoperative allogeneic transfusions. Estimated blood loss, levels fused, volume(s) transfused, and all related complications were recorded. Costs included the cost of allogeneic blood transfusion, setting up the cell saver recovery system, and infusing autologous blood from cell saver, whereas effectiveness measures were allogeneic blood transfusions averted and quality adjusted life years. The incremental cost-effectiveness ratio was $55,538 per allogeneic transfusion averted, with a decrease in the transfusion rate from 40.0% to 38.7% associated with the cell saver approach. This translated into an incremental cost-effectiveness ratio of $5,555,380 per quality adjusted life years gained, which is well above the threshold for an intervention to be considered cost-effective ($100,000 per quality adjusted life years gained). The use of cell saver during a single-level PLDF does not significantly reduce the need for allogeneic blood transfusion and is not cost-effective. The high cost of cell saver in combination with the low complication rate of allogeneic blood transfusion

The Effect of Anthocyanins on Blood Pressure

PubMed Central

Zhu, Yongjian; Bo, Yacong; Wang, Xi; Lu, Wenjie; Wang, Xule; Han, Zhanying; Qiu, Chunguang

2016-01-01

Abstract The findings of clinical studies concerning the association between anthocyanins supplementation and blood pressure (BP) are inconsistent. In order to provide a more precise estimate of the overall effect of anthocyanins on systolic blood pressure (SBP) and diastolic blood pressure (DBP), we conducted a meta-analysis of clinical trials about anthocyanins supplementation and BP. PubMed, Web of Science, Wanfang Database, and China National Knowledge Infrastructure (CNKI) (until October 2015) were searched to identify potential studies with information on anthocyanins extract supplementation and arterial BP. The weighted mean difference (WMD) and 95% confidence interval (CI) were used as a summary statistic. Net changes in SBP and DBP between anthocyanins supplementation and placebo groups were calculated by subtracting the values at end of follow-up from those at baseline. Meta regression was used to explore the potential moderators of effect size. The publication bias was assessed using Begger's Funnel plots and Egger's tests; P < 0.05 was considered to be statistically significant. Finally, 6 clinical studies with 472 participants for the effect of anthocyanins consumption on BP were included in the present meta-analysis. There is no significant effect on either SBP (WMD: 1.15 mm Hg, 95% CI: −3.17 to 5.47, I2 = 56%) or DBP (WMD: 1.06 mm Hg, 95% CI: −0.71 to 2.83, I2 = 0%) following supplementation with anthocyanins. In summary, results from this meta-analysis do not favor any clinical efficacy of supplementation with anthocyanins in improving blood pressure. Further well-designed large randomized controlled trials (RCTs) with long follow-up period are needed to verify the association of anthocyanins supplementation and blood pressure. PMID:27082604

An update on the blood vessel in migraine

PubMed Central

Brennan, K.C.; Charles, Andrew

2017-01-01

Purpose of review The cranial blood vessel is considered an integral player in the pathophysiology of migraine, but its perceived role has been subject to much discussion and controversy over the years. We will discuss the evolution in our scientific understanding of cranial blood vessels (primarily arteries) in migraine. Recent findings Recent developments have clarified the role of cranial blood vessels in the trigemino-vascular system and in cortical spreading depression. An underlying theme is the intimate relation between vascular activity and neural function, and we will emphasize the various roles of the blood vessel that go beyond delivering blood. We conclude that migraine cannot be understood, either from a research or clinical point of view, without an understanding of the vascular derangements that accompany it. Summary Migraine is accompanied by significant derangements in vascular function that may represent important targets for investigation and treatment. PMID:20216215

[IL-1beta and PGE2 production in whole blood and gingival fluid in women with periodontitis and preterm low birth weight].

PubMed

Konopka, Tomasz; Rutkowska, Monika; Hirnle, Lidia; Kopeć, Wacław

2004-05-01

The aim of the investigation was to evaluate of IL-1beta and PGE2 concentrations in gingival fluid, whole blood as well as IL-1beta, PGE2 production after Escherichia coli lipopolysaccharide stimulation in whole blood in women with preterm low birth weight (PLBW), as compared to the control group. A case-control study of 88 postpartum women aged 17 to 39 was performed. The case group consisted of 52 women with PLBW and the control group consisted of 36 women giving birth in time. Concentration of inflammatory mediators in gingival fluid, blood serum and IL-1beta, PGE2 production in whole blood after bacterial lipopolysaccharide stimulation were determined by means of immunoenzymatic method. The levels of IL-1beta and PGE2 in gingival fluid were significantly higher in all PLBW mothers (also PLBW primiparous) than in the control group. In addition in the primiparous with PLBW group significantly higher PGE2 concentration in blood serum was found compared to the primiparous controls. There were no significant differences between women with PLBW and the controls together with a significantly higher production of IL-1beta and PGE2 in whole blood after LPS stimulation in women with periodontitis and gingivitis compared to subjects with healthy periodontium. Such findings suggest that inflammatory mediator synthesis is mainly result of specific cells exposition to bacterial products. Therefore it seems that more frequent occurrence of the phenotype of hyperactive cells that synthesise these mediators is not responsible for PLBW.

[Blood safety: malaria and blood donation in Africa].

PubMed

Tayou Tagny, C; Mbanya, D; Garraud, O; Lefrère, J-J

2007-11-01

Malaria is a principal cause of mortality in Africa and represents a major blood-borne disease. The studies made on the continent show that transfusion-associated malaria is highly prevalent in blood donors groups and that some risk factors and clinical manifestations are frequently observed. The disease is mostly asymptomatic and the signs are mild, which reduces significantly an efficient selection of the blood donors during the predonation interview and a secure supply of blood products. Furthermore, the lack of appropriate screening assays of the malaria in blood banks on the continent limit the diagnosis of the disease and hamper the blood safety. However, the prevention of transfusion-associated malaria is a frequently asked question. The destruction of the parasite in the blood bag and the recipient anti-malarial prophylaxis are the described possibilities, added to local programs against the vectors of the disease.

Chemical composition and biological value of spray dried porcine blood by-products and bone protein hydrolysate for young chickens.

PubMed

Jamroz, D; Wiliczkiewicz, A; Orda, J; Skorupińska, J; Słupczyńska, M; Kuryszko, J

2011-10-01

The chemical composition of spray dried porcine blood by-products is characterised by wide variation in crude protein contents. In spray dried porcine blood plasma (SDBP) it varied between 670-780 g/kg, in spray dried blood cells (SDBC) between 830-930 g/kg, and in bone protein hydrolysate (BPH) in a range of 740-780 g/kg. Compared with fish meal, these feeds are poor in Met and Lys. Moreover, in BPH deep deficits of Met, Cys, Thr and other amino acids were found. The experiment comprised 7 dietary treatments: SDBP, SDBC, and BPH, each at an inclusion rate of 20 or 40 g/kg diet, plus a control. The addition of 20 or 40 g/kg of the analysed meals into feeds for very young chickens (1-28 d post hatch) significantly decreased the body weight (BW) of birds. Only the treatments with 40 g/kg of SDBP and SDBC showed no significant difference in BW as compared with the control. There were no significant differences between treatments and type of meal for feed intake, haematocrit and haemoglobin concentrations in blood. Addition of bone protein and blood cell meals to feed decreased the IgG concentration in blood and caused shortening of the femur and tibia bones. However, changes in the mineral composition of bones were not significantly affected by the type of meal used. The blood by-products, which are rich in microelements, improved retention of Ca and Cu only. In comparison to control chickens, significantly better accretion of these minerals was found in treatments containing 20 g/kg of SDBP or 40 g/kg of SDBC. Great variability in apparent ileal amino acid digestibility in chickens was determined. In this respect, some significant differences related to the type of meal fed were confirmed for Asp, Pro, Val, Tyr and His. In general, the apparent ileal digestibility of amino acids was about 2-3 percentage units better in chickens fed on diets containing the animal by products than in control birds.

Forum on orthophotography: Summary Report

USGS Publications Warehouse

,

1990-01-01

summaries of the various presentations given by the program participants. The appendixes to the report include a list of forum cosponsoring agencies and cooperating organizations, a summary listing of forum registrants by organizational affiliation, and the forum registration list. Also included in the appendkes is the Higher Resolution Orthophoto Products Survey that was sent to each participant following the forum to assist in the identification of near- and longer-term applications, and the determination of requirements, for higher-resolution orthophoto products.

9 CFR 95.16 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Blood meal, blood albumin, intestines... Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; importations permitted subject to restrictions. Blood meal, blood albumin, bone meal, intestines, or other animal...

9 CFR 95.16 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Blood meal, blood albumin, intestines... Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; importations permitted subject to restrictions. Blood meal, blood albumin, bone meal, intestines, or other animal...

9 CFR 95.16 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Blood meal, blood albumin, intestines... Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; importations permitted subject to restrictions. Blood meal, blood albumin, bone meal, intestines, or other animal...

Nimbus-7 data product summary

NASA Technical Reports Server (NTRS)

Oakes, Arnold G.; Han, Daesoo; Kyle, H. Lee; Feldman, Gene Carl; Fleig, Albert J.; Hurley, Edward J.; Kaufman, Barbara A.

1989-01-01

Data sets resulting from the first nine years of operations of the Nimbus-7 Satellite are briefly described. After a brief description of the Nimbus-7 Mission, each of the eight experiments on-board the satellite (Coastal Zone Color Scanner (CZCS), Earth Radiation Budget (ERB), Limb Infrared Monitor of the Stratosphere (MIMS), Stratospheric Aerosol Measurement II (SAM II), Stratospheric and Mesospheric Sounder (SAMS), Solar Backscatter Ultraviolet/Total Ozone Mapping Spectrometer (SBUV/TOMS), Scanning Multichannel Microwave Radiometer (SMMR) and the Temperature Humidity Infrared Radiometer (THIR) are introduced and their respective data products are described in terms of media, general format, and suggested applications. Extensive references are provided. Instructions for obtaining further information, and for ordering data products are given.

21 CFR 864.9185 - Blood grouping view box.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view box...

21 CFR 864.9185 - Blood grouping view box.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view box...

21 CFR 864.9185 - Blood grouping view box.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view box...

21 CFR 864.9185 - Blood grouping view box.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view box...

21 CFR 864.9185 - Blood grouping view box.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view box...

21 CFR 864.9100 - Empty container for the collection and processing of blood and blood components.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of blood and blood components. 864.9100 Section 864.9100 Food and Drugs FOOD AND DRUG ADMINISTRATION... Used In Establishments That Manufacture Blood and Blood Products § 864.9100 Empty container for the collection and processing of blood and blood components. (a) Identification. An empty container for the...

21 CFR 864.9100 - Empty container for the collection and processing of blood and blood components.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of blood and blood components. 864.9100 Section 864.9100 Food and Drugs FOOD AND DRUG ADMINISTRATION... Used In Establishments That Manufacture Blood and Blood Products § 864.9100 Empty container for the collection and processing of blood and blood components. (a) Identification. An empty container for the...

21 CFR 864.9100 - Empty container for the collection and processing of blood and blood components.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of blood and blood components. 864.9100 Section 864.9100 Food and Drugs FOOD AND DRUG ADMINISTRATION... Used In Establishments That Manufacture Blood and Blood Products § 864.9100 Empty container for the collection and processing of blood and blood components. (a) Identification. An empty container for the...

21 CFR 864.9100 - Empty container for the collection and processing of blood and blood components.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of blood and blood components. 864.9100 Section 864.9100 Food and Drugs FOOD AND DRUG ADMINISTRATION... Used In Establishments That Manufacture Blood and Blood Products § 864.9100 Empty container for the collection and processing of blood and blood components. (a) Identification. An empty container for the...

21 CFR 864.9100 - Empty container for the collection and processing of blood and blood components.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of blood and blood components. 864.9100 Section 864.9100 Food and Drugs FOOD AND DRUG ADMINISTRATION... Used In Establishments That Manufacture Blood and Blood Products § 864.9100 Empty container for the collection and processing of blood and blood components. (a) Identification. An empty container for the...

Earth observing system. Output data products and input requirements, version 2.0. Volume 3: Algorithm summary tables and non-EOS data products

NASA Technical Reports Server (NTRS)

Lu, Yun-Chi; Chang, Hyo Duck; Krupp, Brian; Kumar, Ravindar; Swaroop, Anand

1992-01-01

Volume 3 assists Earth Observing System (EOS) investigators in locating required non-EOS data products by identifying their non-EOS input requirements and providing the information on data sets available at various Distributed Active Archive Centers (DAAC's), including those from Pathfinder Activities and Earth Probes. Volume 3 is intended to complement, not to duplicate, the the EOSDIS Science Data Plan (SDP) by providing detailed data set information which was not presented in the SDP. Section 9 of this volume discusses the algorithm summary tables containing information on retrieval algorithms, expected outputs and required input data. Section 10 describes the non-EOS input requirements of instrument teams and IDS investigators. Also described are the current and future data holdings of the original seven DAACS and data products planned from the future missions and projects including Earth Probes and Pathfinder Activities. Section 11 describes source of information used in compiling data set information presented in this volume. A list of data set attributes used to describe various data sets is presented in section 12 along with their descriptions. Finally, Section 13 presents the SPSO's future plan to improve this report .

Productivity loss due to premature mortality caused by blood cancer: a study based on patients undergoing stem cell transplantation.

PubMed

Ortega-Ortega, Marta; Oliva-Moreno, Juan; Jiménez-Aguilera, Juan de Dios; Romero-Aguilar, Antonio; Espigado-Tocino, Ildefonso

2015-01-01

Stem cell transplantation has been used for many years to treat haematological malignancies that could not be cured by other treatments. Despite this medical breakthrough, mortality rates remain high. Our purpose was to evaluate labour productivity losses associated with premature mortality due to blood cancer in recipients of stem cell transplantations. We collected primary data from the clinical histories of blood cancer patients who had undergone stem cell transplantation between 2006 and 2011 in two Spanish hospitals. We carried out a descriptive analysis and calculated the years of potential life lost and years of potential productive life lost. Labour productivity losses due to premature mortality were estimated using the Human Capital method. An alternative approach, the Friction Cost method, was used as part of the sensitivity analysis. Our findings suggest that, in a population of 179 transplanted and deceased patients, males and people who die between the ages of 30 and 49 years generate higher labour productivity losses. The estimated loss amounts to over €31.4 million using the Human Capital method (€480,152 using the Friction Cost method), which means an average of €185,855 per death. The highest labour productivity losses are produced by leukaemia. However, lymphoma generates the highest loss per death. Further efforts are needed to reduce premature mortality in blood cancer patients undergoing transplantations and reduce economic losses. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Noradrenaline inhibits lipopolysaccharide-induced tumor necrosis factor and interleukin 6 production in human whole blood.

PubMed Central

van der Poll, T; Jansen, J; Endert, E; Sauerwein, H P; van Deventer, S J

1994-01-01

Sepsis and lipopolysaccharide (LPS) trigger the systemic release of both cytokines and catecholamines. Cytokines are known to be capable of eliciting a stress hormone response in vivo. The present study sought insight into the effect of noradrenaline on LPS-induced release of tumor necrosis factor alpha (TNF) and interleukin 6 (IL-6) in human whole blood. Whole blood was incubated with LPS for 4 h at 37 degrees C in the presence and absence of noradrenaline and/or specific alpha and beta antagonists and agonists. Noradrenaline caused a dose-dependent inhibition of LPS-induced TNF and IL-6 production. This effect could be completely prevented by addition of the specific beta 1, antagonist metoprolol, while it was not affected by the alpha antagonist phentolamine. Specific beta-adrenergic stimulation by isoprenaline mimicked the inhibiting effect of noradrenaline on LPS-evoked cytokine production, whereas alpha-adrenergic stimulation by phenylephrine had no effect. Fluorescence-activated cell sorter analysis demonstrated that beta-adrenergic stimulation had no effect on LPS binding to and internalization into mononuclear cells or on the expression of CD14, the major receptor for LPS on mononuclear cells. In acute sepsis, enhanced release of noradrenaline may be part of a negative feedback mechanism meant to inhibit ongoing TNF and IL-6 production. PMID:8168970

75 FR 54343 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0436... That Collect Whole Blood and Blood Components AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is...

Coagulation management in trauma-associated coagulopathy: allogenic blood products versus coagulation factor concentrates in trauma care.

PubMed

Klages, Matthias; Zacharowski, Kai; Weber, Christian Friedrich

2016-04-01

Coagulation management by transfusion of allogenic blood products and coagulation factors are competing concepts in current trauma care. Rapid and adequate therapy of trauma-associated coagulopathy is crucial to survival of severely injured patients. Standard coagulation tests such as prothrombin time and activated partial thromboplastin time are commonly used, but these tests are inappropriate for monitoring and guiding therapy in trauma patients. Coagulation factor-based treatment showed promising results, but randomized trials have not yet been performed. In addition, viscoelastic tests are needed to guide therapy, although there is in fact limited evidence for these in tests in trauma care. Regarding transfusion therapy with allogenic blood products, plasma transfusion has been associated with improved survival in trauma patients following massive transfusion. In contrast, patients not requiring massive transfusion seem to be at risk for suffering complications with increasing volumes of plasma transfused. The collective of trauma patients is heterogeneous. Despite the lack of evidence, there are strong arguments for individualized patient treatment with coagulation factors for some indications and to abstain from the use of fresh frozen plasma. In patients with severe trauma and major bleeding, plasma, platelets, and red blood cells should be considered to be administered at a ratio of 1 : 1 : 1.

Intraosseous infusion of blood products and epinephrine in an adult patient in hemorrhagic shock.

PubMed

Burgert, James M

2009-10-01

A 79-year-old woman presented in the postanesthesia care unit with hematemesis following replacement of a jejunostomy tube. Her medical history included recurrent stage IIIC ovarian cancer. The patient rapidly decompensated despite blood products administered through the patient's implanted medication port. The anesthesia service was consulted for resuscitative support. Examination revealed an alert, hypotensive elderly female in hemorrhagic shock. While peripheral intravenous (IV) access was sought, her condition further deteriorated. Attempts at peripheral access were determined futile and central venous access would be required. An intraosseous (IO) catheter was placed in the proximal medial aspect of the left tibia using the EZ-IO device (Vidacare Corp, San Antonio, Texas). Crystalloid and colloid fluids, blood products, and drugs were administered via the IO route, stabilizing the patient's condition during the central access procedure. The IO route was used throughout the resuscitative effort. Hemostasis was achieved, and the patient was admitted to the intensive care unit. Intraosseous infusion is a valuable and underutilized technique in managing patients in hemorrhagic shock with poor IV access. Anesthesia providers should seek education and training from those experienced in IO placement techniques and consider use of the IO route early in the resuscitative process.

Blood product transfusion in emergency department patients: a case-control study of practice patterns and impact on outcome.

PubMed

Beyer, Alexander; Rees, Ryan; Palmer, Christopher; Wessman, Brian T; Fuller, Brian M

2017-12-01

Blood product transfusion occurs in a significant percentage of intensive care unit (ICU) patients. Pulmonary complications, such as acute respiratory distress syndrome (ARDS), occurring in the setting of transfusion, are associated with increased morbidity and mortality. Contrary to the ICU setting, there is little evidence describing the epidemiology of transfusion in the emergency department (ED) or its potential impact on outcome. The objectives of this study were to: (1) characterize transfusion practices in the ED with respect to patient characteristics and pre-transfusion laboratory values; and (2) investigate the effect of ED blood product transfusion on the incidence of pulmonary complications after admission. We hypothesized that blood product transfusion would increase the event rate for pulmonary complications, and have a negative impact on other clinically significant outcomes. This was a retrospective case-control study with one-one matching of 204 transfused ED patients to 204 non-transfused controls. The primary outcome was a composite pulmonary outcome that included: acute respiratory failure, new need for ICU admission, and ARDS. Multivariable logistic regression was used to evaluate the primary outcome as a function of transfusion. One-hundred twenty four (60.8%) patients were transfused packed red blood cells (PRBC) in the ED. The mean pre-transfusion hemoglobin level was 8.5 g/dl. There were 73 patients with a hemoglobin value ≥10 g/dl; 19 (26.0%) received a PRBC transfusion. A total of 54 (26.5%) patients were transfused platelets. The main indications were thrombocytopenia (27.8%) and neurologic injury (24.1%). Ten patients had a platelet level <10,000 (guideline recommended threshold for transfusion to prevent spontaneous hemorrhage). The mean platelet count for neurologic injury patients was 197,000 prior to transfusion. The primary outcome occurred in 26 control patients (12.7%), as compared with 28 cases (13.7%). In multivariable

Effects of chocolate-based products intake on blood glucose, insulin and ghrelin levels and on satiety in young people: a cross-over experimental study.

PubMed

Zhang, Cai-Xia; Long, Wei-Qing; Ye, Yan-Bin; Lu, Min-Shan; Zhang, Nai-Qi; Xu, Ming; Huang, Jing; Su, Yi-Xiang

2018-02-19

This cross-over experimental study aimed to examine the effects of filled chocolate consumption on blood glucose, insulin and ghrelin levels in 20 volunteers. After a one-week run-in period, study participants consumed two chocolate-based products, the tested biscuit or water for 21 days as a morning snack. After a two-week wash-out period, participants consumed another tested food for another 21 days. Each participant consumed all four test foods within an 18-week period. The participants' blood insulin increased slowly after two chocolate-based products intakes on the first day and satiety levels after eating chocolate-based products and the tested biscuit were the same. Chocolate consumption for three weeks had no adverse effects on blood glucose, insulin or ghrelin levels. In conclusion, compared to eating the tested biscuit, 21-day consumption of the tested chocolate-based products had no adverse effects on the blood glucose, insulin and ghrelin levels. This trial is registered with chictr.org.cn: ChiCTR-IOR-16009525.

Cardiovascular pharmacology of quazodine (MJ-1988), with particular reference to effects of myocardial blood flow and metabolic heat production.

PubMed

Parratt, J R; Winslow, E

1971-06-01

1. The effects of intravenous infusions of quazodine (6,7-dimethoxy-4-ethylquinazoline; MJ-1988) on myocardial blood flow, myocardial metabolic heat production and on general haemodynamics have been studied in cats anaesthetized with sodium pentobarbitone.2. Quazodine (0.25 and 0.5 (mg/kg)/min for 10 min) decreased diastolic blood pressure, peripheral vascular resistance, systolic ejection time and left ventricular end-diastolic pressure. Heart rate, cardiac effort, output and external work and left ventricular dP/dt were markedly increased. These changes are indicative of increased myocardial contractility and peripheral vasodilatation.3. In a dose of (1.0 mg/kg)/min, quazodine had a more marked hypotensive effect, systolic pressure being significantly reduced, and had less effect on left ventricular dP/dt and cardiac effort. Calculated external cardiac work was slightly reduced and there were very occasional nodal arrhythmias.4. Changes in heart rate, aortic dP/dt and diastolic blood pressure induced by quazodine were unaffected by the previous administration of the beta-adrenoceptor blocking agent alprenolol in a dose (1.0 mg/kg) which abolished the effects of isoprenaline.5. In all doses, quazodine markedly increased local blood flow (by 70-540%) around an implanted myocardial heated thermocouple recorder. ;Corrected temperature', an index of local myocardial metabolic heat production, was almost unchanged and it is suggested that increased myocardial contractility, occurring with unchanged metabolic heat production and oxygen consumption, probably results from a concomitant decrease in intramural wall tension.

Brazilian Propolis: A Natural Product That Improved the Fungicidal Activity by Blood Phagocytes

PubMed Central

Possamai, Muryllo Mendes; Honorio-França, Adenilda Cristina; Reinaque, Ana Paula Barcelos; França, Eduardo Luzia; Souto, Paula Cristina de Souza

2013-01-01

Natural product incorporation into microcarriers increases the bioavailability of these compounds, consequently improving their therapeutic properties. Natural products, particularly those from bees such as propolis, are widely used in popular medicine. Propolis is a powerful treatment for several diseases. In this context, the present study evaluated the effect of propolis Scaptotrigona sp. and its fractions, alone or adsorbed to polyethylene glycol (PEG) microspheres, on the activity of human phagocytes against Candida albicans. The results show that propolis exerts a stimulatory effect on these cells to assist in combating the fungus, especially as the crude extract is compared with the fractions. However, when incorporated into microspheres, these properties were significantly potentiated. These results suggest that propolis adsorbed onto PEG microspheres has immunostimulatory effects on phagocytes in human blood. Therefore, propolis may potentially be an additional natural product that can be used for a variety of therapies. PMID:23509737

Pending laboratory tests and the hospital discharge summary in patients discharged to sub-acute care.

PubMed

Walz, Stacy E; Smith, Maureen; Cox, Elizabeth; Sattin, Justin; Kind, Amy J H

2011-04-01

Previous studies have noted a high (41%) prevalence and poor discharge summary communication of pending laboratory (lab) tests at the time of hospital discharge for general medical patients. However, the prevalence and communication of pending labs within a high-risk population, specifically those patients discharged to sub-acute care (i.e., skilled nursing, rehabilitation, long-term care), remains unknown. To determine the prevalence and nature of lab tests pending at hospital discharge and their inclusion within hospital discharge summaries, for common sub-acute care populations. Retrospective cohort study. Stroke, hip fracture, and cancer patients discharged from a single large academic medical center to sub-acute care, 2003-2005 (N = 564) Pending lab tests were abstracted from the laboratory information system (LIS) and from each patient's discharge summary, then grouped into 14 categories and compared. Microbiology tests were sub-divided by culture type and number of days pending prior to discharge. Of sub-acute care patients, 32% (181/564) were discharged with pending lab tests per the LIS; however, only 11% (20/181) of discharge summaries documented these. Patients most often left the hospital with pending microbiology tests (83% [150/181]), particularly blood and urine cultures, and reference lab tests (17% [30/181]). However, 82% (61/74) of patients' pending urine cultures did not have 24-hour preliminary results, and 19% (13/70) of patients' pending blood cultures did not have 48-hour preliminary results available at the time of hospital discharge. Approximately one-third of the sub-acute care patients in this study had labs pending at discharge, but few were documented within hospital discharge summaries. Even after considering the availability of preliminary microbiology results, these omissions remain common. Future studies should focus on improving the communication of pending lab tests at discharge and evaluating the impact that this improved

Cytokine Production in Mixed Cultures of Mesenchymal Stromal Cells from Wharton's Jelly and Peripheral Blood Lymphocytes.

PubMed

Poltavtsev, A M; Poltavtseva, R A; Yushina, M N; Volgina, N E; Svirshchevskaya, E V

2017-05-01

We compared the production of 19 humoral factors in mixed cultures of mesenchymal stromal cells from Wharton's jelly and allogenic peripheral blood lymphocytes. For evaluation of the specificity of immunosuppressive activity of mesenchymal stromal cells, comparative analysis of the production of these humoral factors in mixed cultures of lymphocytes and epithelial BxPC-3 cells was conducted. The production of soluble factors in both mono- and mixed cultures significantly correlated (p<0.05). The maximum production was found for proinflammatory chemokine IP-10 and IFN-γ and anti-inflammatory cytokine IL-10. The major difference of mesenchymal stromal cells from epithelial BxPC-3 cells was 7-fold higher production of IL-10, which can explain the immunosuppressive effect of mesenchymal stromal cells.

Altered cytokine production by specific human peripheral blood cell subsets immediately following space flight

NASA Technical Reports Server (NTRS)

Crucian, B. E.; Cubbage, M. L.; Sams, C. F.

2000-01-01

In this study, flow cytometry was used to positively identify the specific lymphocyte subsets exhibiting space flight-induced alterations in cytokine production. Whole blood samples were collected from 27 astronauts at three points (one preflight, two postflight) surrounding four space shuttle missions. Assays performed included serum/urine stress hormones, white blood cell (WBC) phenotyping, and intracellular cytokine production following mitogenic stimulation. Absolute levels of peripheral granulocytes were significantly elevated following space flight, but the levels of circulating lymphocytes and monocytes were unchanged. Lymphocyte subset analysis demonstrated a decreased percentage of T cells, whereas percentages of B cells and natural killer (NK) cells remained unchanged after flight. Nearly all the astronauts exhibited an increased CD4/CD8 T cell ratio. Assessment of naive (CD45RA+) vs. memory (CD45RO+) CD4+ T cell subsets was ambiguous, and subjects tended to group within specific missions. Although no significant trend was seen in absolute monocyte levels, a significant decrease in the percentage of the CD14+ CD16+ monocytes was seen following space flight in all subjects tested. T cell (CD3+) production of interleukin-2 (IL-2) was significantly decreased after space flight, as was IL-2 production by both CD4+ and CD8+ T cell subsets. Production of interferon-gamma (IFN-gamma) was not altered by space flight for the CD8+ cell subset, but there was a significant decrease in IFN-gamma production for the CD4+ T cell subset. Serum and urine stress hormone analysis indicated significant physiologic stresses in astronauts following space flight. Altered peripheral leukocyte subsets, altered serum and urine stress hormone levels, and altered T cell cytokine secretion profiles were all observed postflight. In addition, there appeared to be differential susceptibility to space flight regarding cytokine secretion by T cell subsets. These alterations may be the

GMP in blood collection and processing.

PubMed

Wagstaff, W

1998-01-01

The principles of Good Manufacturing Practice have, in the main, been universally developed for the guidance of the pharmaceutical industry rather than for transfusion services. However, these rules and guides are increasingly being adapted for use in blood centres, in the production of labile blood components and of plasma for fractionation. The guide for pharmaceutical industries produced by the commission of the European Communities is used as a model here, the nine basic requirements being those applicable to Quality Management, personnel, premises and equipment, document, production, Quality Control, contract manufacture and analysis, complaints and product recall, and self-inspection. Though having more direct application to the production laboratory preparing blood components, the majority of these requirements and principles are also directly applicable to all of the activities involved in blood collection.

NOTE: Blood irradiation with accelerator produced electron beams

NASA Astrophysics Data System (ADS)

Butson, M. J.; Cheung, T.; Yu, P. K. N.; Stokes, M. J.

2000-11-01

Blood and blood products are irradiated with gamma rays to reduce the risk of graft versus host disease (GVHD). A simple technique using electron beams produced by a medical linear accelerator has been studied to evaluate irradiation of blood and blood products. Variations in applied doses for a single field 20 MeV electron beam are measured in a phantom study. Doses have been verified with ionization chambers and commercial diode detectors. Results show that the blood product volume can be given a relatively homogeneous dose to within 6% using 20 MeV electrons without the need to rotate the blood bags or the beam entry point. The irradiation process takes approximately 6.5 minutes for 30 Gy applied dose to complete as opposed to 12 minutes for a dual field x-ray field irradiation at our centre. Electron beams can be used to satisfactorily irradiate blood and blood products in a minimal amount of time.

Effects of dairy products consumption on weight loss and blood chemistry in premenopausal obese women.

PubMed

Celik, Neslihan; Inanc, Neriman

2016-01-01

To determine the effects of dairy calcium on changes in body weight and body fat mass in obese women on a weight-loss diet. The non-randomised controlled study was conducted at Sivas Government Hospital, Turkey, between January and March 2010, and comprised obese women outpatients coming to the Nutrition and Diet Clinic. The participants were assigned to three groups according to their intake of dairy products as control, low dairy and high dairy groups. Measurements of anthropometry, blood pressure and analysis of blood chemistry were done before and after the intervention. The mean age of the 65 women was 33.10±6.18 years. There were 20(30.7%) women in control group, 22(33.8%) in high dairy group and 23(35.3%) in low dairy group. At the end of the study, body weight, body mass index, waist and hip circumferences, waist/hip ratio, body fat percentage, and fat mass significantly decreased within the groups (p<0.001) whereas no difference was determined between the groups. Plasma total cholesterol levels decreased (p<0.05, p<0.001) and high-density lipoprotein cholesterol levels increased (p<0.05) in the two intervention groups. Systolic blood pressure was negatively correlated with dairy calcium (?=0.460, p<0.05). In women following a weight-loss programme, increasing the amount of dairy products was not effective in improving weight-loss compared to calorie restriction alone.

An analysis on the fate of a selection of blood products derived from cytomegalovirus-seronegative donors at three tertiary referral hospitals in Australia.

PubMed

Hirani, Rena; Tohidi-Esfahani, Ibrahim; Mondy, Phillip; Irving, David O

2018-03-01

Supply of cytomegalovirus (CMV)-seronegative blood products in Australia is an ongoing challenge. Requests for CMV-negative products are increasing with prediction that the demand will exceed supply by 2019. Clinical information evaluating how these products are being utilized by health providers within Australia is limited. This study aimed to identify indications for use of CMV-negative blood products and gather data to support possible practice change. All CMV-negative products issued to three tertiary Australian hospitals from May 1, 2016, to May 31, 2016, were identified (n = 1219). This equated to 1044 red blood cell units and 175 platelet units. Data were collected on the fate of each unit. Information collected included the indication and urgency of transfusion, reason for discard, product age, and recipient CMV immunoglobulin G status. Of the units issued during the audit period, 32 (2.6%) were discarded by the hospitals. Transfusion data were collected on 411 units. Of these, 136 (33.1%) were transfused to CMV-positive recipients, in most cases for hematology indications, and 67 units (16.3%) were transfused to CMV-negative requiring recipients. A total of 144 (35%) CMV-negative units were selected based on their irradiation status. Other reasons for the selection of CMV-negative units included product close to expiry (n = 134, 32.6%) or specific patient phenotype requirements (n = 31, 7.5%). In this study, the majority of CMV-negative blood products were not used for CMV-negative requiring recipients. Alterations to inventory management would be advantageous to ensure continued supply for CMV-negative requiring recipients. © 2017 AABB.

Blood Collection

NASA Technical Reports Server (NTRS)

1999-01-01

The method that is used for the collection, storage and real-time analysis of blood and other bodily fluids has been licensed to DBCD, Inc. by NASA. The result of this patent licensing agreement has been the development of a commercial product that can provide serum or plasma from whole blood volumes of 20 microliters to 4 milliliters. The device has a fibrous filter with a pore size of less than about 3 microns, and is coated with a mixture of mannitol and plasma fraction protein. The coating causes the cellular fraction to be trapped by the small pores, leaving the cellular fraction intact on the fibrous filter while the acellular fraction passes through the filter for collection in unaltered form from the serum sample collection chamber. The method used by this product is useful to NASA for blood analysis on manned space missions.

21 CFR 640.14 - Testing the blood.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.14 Testing the blood. Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and...

21 CFR 640.14 - Testing the blood.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.14 Testing the blood. Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and...

21 CFR 640.14 - Testing the blood.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.14 Testing the blood. Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and...

21 CFR 640.14 - Testing the blood.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.14 Testing the blood. Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and...

21 CFR 640.14 - Testing the blood.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Red Blood Cells § 640.14 Testing the blood. Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and...

Biomonitoring using dried blood spots: detection of ochratoxin A and its degradation product 2'R-ochratoxin A in blood from coffee drinkers.

PubMed

Cramer, Benedikt; Osteresch, Bernd; Muñoz, Katherine A; Hillmann, Hartmut; Sibrowski, Walter; Humpf, Hans-Ulrich

2015-09-01

In this study, human exposure to the mycotoxin ochratoxin A (OTA) and its thermal degradation product 2'R-ochratoxin A (2'R-OTA, previously named as 14R-Ochratoxin A [22]) through coffee consumption was assessed. LC-MS/MS and the dried blood spot (DBS) technique were used for the analysis of blood samples from coffee and noncoffee drinkers (n = 50), and food frequency questionnaires were used to document coffee consumption. For the detection of OTA and 2'R-OTA in blood, a new sensitive and efficient sample preparation method based on DBS was established and validated. Using this technique 2'R-OTA was for the first time detected in biological samples. Comparison between coffee drinkers and noncoffee drinkers showed for the first time that 2'R-OTA was only present in blood from the first group while OTA could be found in both groups in a mean concentration of 0.21 μg/L. 2'R-OTA mean concentration was 0.11 μg/L with a maximum concentration of 0.414 μg/L. Thus, in average 2'R-OTA was approx. half the concentration of OTA but in some cases even exceeded OTA levels. No correlation between the amounts of coffee consumption and OTA or 2'R-OTA levels was observed. The results of this study revealed for the first time a high exposure of coffee consumers to 2'R-OTA, a compound formed from OTA during coffee roasting. Since little information is available regarding toxicity and possible carcinogenicity of this compound, further OTA monitoring in blood including 2'R-OTA is advisable. © 2015 The Authors. Molecular Nutrition & Food Research published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Soluble antigens from group B streptococci induce cytokine production in human blood cultures.

PubMed Central

von Hunolstein, C; Totolian, A; Alfarone, G; Mancuso, G; Cusumano, V; Teti, G; Orefici, G

1997-01-01

Group B streptococcal antigens stimulated tumor necrosis factor alpha (TNF-alpha), interleukin-1 (IL-1), and IL-6 production in human blood cultures in a concentration- and time-dependent fashion. The minimal concentrations of type-specific polysaccharides, lipoteichoic acid, and group-specific polysaccharide required to produce these effects were, respectively, 0.01, 1, and 10 microg/ml. Cell separation experiments indicated that monocytes were the cell type mainly responsible for cytokine production. Time course studies indicated that TNF-alpha was released before the other cytokines. TNF-alpha, however, did not appear to directly induce IL-1beta, as shown by blockade experiments with anti-TNF-alpha antibodies. IL-6 levels were moderately but significantly decreased by anti-TNF-alpha. These data indicate that several products from group B streptococci are able to directly stimulate human monocytes to release TNF-alpha, IL-1beta, and IL-6. These findings may be clinically relevant, since proinflammatory cytokines can mediate pathophysiologic changes during sepsis. PMID:9317001

Effect of cocoa products on blood pressure: systematic review and meta-analysis.

PubMed

Desch, Steffen; Schmidt, Johanna; Kobler, Daniela; Sonnabend, Melanie; Eitel, Ingo; Sareban, Mahdi; Rahimi, Kazem; Schuler, Gerhard; Thiele, Holger

2010-01-01

Cocoa products such as dark chocolate and cocoa beverages may have blood pressure (BP)-lowering properties due to their high content of plant-derived flavanols. We performed a meta-analysis of randomized controlled trials assessing the antihypertensive effects of flavanol-rich cocoa products. The primary outcome measure was the change in systolic and diastolic BP between intervention and control groups. In total, 10 randomized controlled trials comprising 297 individuals were included in the analysis. The populations studied were either healthy normotensive adults or patients with prehypertension/stage 1 hypertension. Treatment duration ranged from 2 to 18 weeks. The mean BP change in the active treatment arms across all trials was -4.5 mm Hg (95% confidence interval (CI), -5.9 to -3.2, P < 0.001) for systolic BP and -2.5 mm Hg (95% CI, -3.9 to -1.2, P < 0.001) for diastolic BP. The meta-analysis confirms the BP-lowering capacity of flavanol-rich cocoa products in a larger set of trials than previously reported. However, significant statistical heterogeneity across studies could be found, and questions such as the most appropriate dose and the long-term side effect profile warrant further investigation before cocoa products can be recommended as a treatment option in hypertension.

Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

PubMed

Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

2015-01-01

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

Suppressed cytokine production in whole blood cultures is related to iron status and is partially corrected following weight reduction in morbidly obese pre-menopausal women

USDA-ARS?s Scientific Manuscript database

Assess ex vivo whole-blood cytokine production and its association with iron status in obese versus non-obese women. Determine the change in ex vivo whole-blood cytokine production six months after restrictive bariatric surgery in the obese group. Subjects were 17 obese (BMI: 46.6 ±7.9 kg/m2) and 1...

Role of Human Health Care Providers and Medical Treatment Facilities in Military Working Dog Care and Accessibility Difficulties with Military Working Dog Blood Products.

PubMed

Giles Iii, James T

2016-01-01

The use of military working dogs (MWDs) in support of military operations has increased dramatically over recent years, as they have proven to be our most reliable deterrent to improvised explosive devices. Healthcare delivery for MWDs in combat presents unique challenges and requires extensive collaboration between veterinarians and human health care providers (HCPs). A successful example is the incorporation of MWD emergency care for nonveterinary HCPs into the Joint Trauma System Clinical Practice Guidelines, which has proven to be a helpful product. Additional challenges that need further solutions include MWDs as patients in human medical treatment facilities (MTFs) and the procurement of appropriate canine blood components in an operational environment. It is often necessary for MWDs to be treated as patients in human MTFs, however, there is no Department of Defense guidance to support this activity. Access to MWD blood products is limited to collection of fresh whole blood in the operational setting. Similar to humans, specific blood component therapy, such as fresh frozen plasma, is often indicated for sick or injured MWDs. Currently there is no formal system in place to deliver any blood products for MWDs or to facilitate collection in theater.

Perception of low-titer group A plasma and potential barriers to using this product: A blood center's experience serving community and academic hospitals.

PubMed

Agaronov, Maksim; DiBattista, Anthony; Christenson, Ellen; Miller-Murphy, Richard; Strauss, Donna; Shaz, Beth H

2016-08-01

To alleviate the shortage of AB plasma, an alternative plasma product, low-titer group A plasma (LTGAP), is now available. The product is indicated for emergency transfusions when the patient's blood group has not been identified. The product's defining anti-B titers vary across institutions, and at our blood center we define <1:100 as low-titer. We created two surveys and emailed them to hospital blood bank managers, supervisors, and medical directors who currently use LTGAP and those that have not ordered it. We calculated the amount of LTGAP that met our <1:100 cutoff. We searched our inventory database to obtain sales of LTGAP, AB, and all other types of plasma in 2014. We learned from the surveys that the product is safe and being used as indicated for only life or limb-threatening emergencies until patient's blood group is known and specific products can be provided. Most common reasons for not using LTGAP were lack of need in non-trauma hospitals and limiting capabilities in blood bank software. Although sales of LTGAP increased by ~5% by end of the first year since introduction, sales of AB plasma remained relatively steady. LTGAP appears to be a safe alternative to group AB plasma for emergency indications. By reviewing our percentage of group A plasma units that meet our low-titer cutoff and the current interest for the product, we can reduce the amount of units we titer each day by ~30% and can readjust that amount if there is increased interest. Besides lack of familiarity and limitations in computer software to incorporate LTGAP, the steady demand for AB plasma can potentially be attributed to trauma centers ordering more AB plasma than needed and potentially wasting it in nonurgent cases to avoid outdating the product and lack of institutional guidelines on when to switch from AB to type-specific plasma resulting in excess AB plasma being transfused. Copyright © 2016 Elsevier Ltd. All rights reserved.

Testing of blood products in a polytrauma model: results of a multi-institutional randomized preclinical trial.

PubMed

Alam, Hasan B; Bice, Leticia M; Butt, Muhammad U; Cho, S David; Dubick, Michael A; Duggan, Michael; Englehart, Michael S; Holcomb, John B; Morris, Melanie S; Prince, M Dale; Schreiber, Martin A; Shults, Christian; Sondeen, Jill L; Tabbara, Malek; Tieu, Brandon H; Underwood, Samantha A

2009-10-01

Trauma-induced coagulopathy, acidosis, and hypothermia form a "lethal triad" that is difficult to treat and is associated with extremely high mortality. This study was performed at three academic centers to evaluate whether resuscitation with blood components could reverse the coagulopathy in a complex polytrauma model. Yorkshire swine (40 +/- 5 kg) were subjected to a three-phase protocol: (a) "Prehospital" phase = femur fracture, hemorrhage (60% blood volume), and 30 minutes shock + infusion of saline (3x shed blood) + induction of hypothermia (33 degrees C); (b) "Early hospital" phase = grade V liver injury; and (c) "Operative" phase= liver packing. After liver packing, the animals (n = 60) were randomized to the following groups: (1) Sham-instrumentation and anesthesia without hemorrhage/injuries, (2) fresh whole blood (FWB), (3) 6% hetastarch (Hextend), (4) fresh frozen plasma/packed RBCs in 1:1 ratio (1:1 FFP/PRBC), and (5) FFP alone. Treatment volumes were equal to the volume of shed blood. Hemodynamic and physiologic parameters and coagulation profile (thrombelastography, prothrombin time, activated partial thromboplastin time, international normalized ratio, and platelets) were monitored during the experiment and for 4 hours posttreatment. At the end of prehospital phase, animals had developed significant acidosis (lactate >5 mmol/L and base deficit >9 mmol/L) and coagulopathy. Posttreatment mortality rates were 85% and 0% for the Hextend and blood component treated groups, respectively (p < 0.05). Hemodynamic parameters and survival rates were similar in groups that were treated with blood products (FWB, FFP, and FFP:PRBC). Animals treated with FFP and Hextend had significant anemia compared with the groups that received red blood cells (FWB and FFP:PRBC). Treatment with FFP and FFP:PRBC corrected the coagulopathy as effectively as FWB, whereas Hextend treatment worsened coagulopathy. In this reproducible model, we have shown that trauma

LEAP 1992: Conference summary

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

Dover, C.B.

1992-12-01

We present a summary of the many new results in antiproton ({bar p}) physics presented at the LEAP `92 conference, in the areas of meson spectroscopy, {bar N}N scattering, annihilation and spin observables, strangeness and charm production, {bar N} annihilation in nuclei, atomic physics with very low energy {bar p}`s, the exploration of fundamental symmetries and interactions with {bar p} (CP, T, CPT, gravitation), and the prospects for new {bar p} facilities at ultralow energies or energies above the LEAR regime ({ge} 2 GeV/c).

LEAP 1992: Conference summary

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

Dover, C.B.

1992-12-01

We present a summary of the many new results in antiproton ([bar p]) physics presented at the LEAP '92 conference, in the areas of meson spectroscopy, [bar N]N scattering, annihilation and spin observables, strangeness and charm production, [bar N] annihilation in nuclei, atomic physics with very low energy [bar p]'s, the exploration of fundamental symmetries and interactions with [bar p] (CP, T, CPT, gravitation), and the prospects for new [bar p] facilities at ultralow energies or energies above the LEAR regime ([ge] 2 GeV/c).

Operational effectiveness and quality assurance mechanisms with stochastic demand of blood supply: blood bank case study.

PubMed

Smith, Alan D

2011-01-01

A general overview of various blood products operational effectiveness and related strategies that can be utilised by service providers (in particular, healthcare providers) is presented in the present study. In terms of the massive volumes of blood products, the North American blood centres collect more than eight million units of whole blood, which represents appropriately 50% of the US and Quebec, Canada?s volunteer donor blood supply. A case study of the quality inspection and inventory control concerns of the Central Blood Bank, located in the metropolitan area of Pittsburgh, PA, is presented. Initially, brief introduction to its general operating environment is followed by sections describing its general situation, quality-service initiatives, and followed by a fairly detailed discussion of the practical applications of lessons learned from the case study.

Prehospital Blood Product Resuscitation for Trauma: A Systematic Review

PubMed Central

Smith, Iain M.; James, Robert H.; Dretzke, Janine; Midwinter, Mark J.

2016-01-01

ABSTRACT Introduction: Administration of high ratios of plasma to packed red blood cells is a routine practice for in-hospital trauma resuscitation. Military and civilian emergency teams are increasingly carrying prehospital blood products (PHBP) for trauma resuscitation. This study systematically reviewed the clinical literature to determine the extent to which the available evidence supports this practice. Methods: Bibliographic databases and other sources were searched to July 2015 using keywords and index terms related to the intervention, setting, and condition. Standard systematic review methodology aimed at minimizing bias was used for study selection, data extraction, and quality assessment (protocol registration PROSPERO: CRD42014013794). Synthesis was mainly narrative with random effects model meta-analysis limited to mortality outcomes. Results: No prospective comparative or randomized studies were identified. Sixteen case series and 11 comparative studies were included in the review. Seven studies included mixed populations of trauma and non-trauma patients. Twenty-five of 27 studies provided only very low quality evidence. No association between PHBP and survival was found (OR for mortality: 1.29, 95% CI: 0.84–1.96, P = 0.24). A single study showed improved survival in the first 24 h. No consistent physiological or biochemical benefit was identified, nor was there evidence of reduced in-hospital transfusion requirements. Transfusion reactions were rare, suggesting the short-term safety of PHBP administration. Conclusions: While PHBP resuscitation appears logical, the clinical literature is limited, provides only poor quality evidence, and does not demonstrate improved outcomes. No conclusions as to efficacy can be drawn. The results of randomized controlled trials are awaited. PMID:26825635

High-resolution crystal structures and STD NMR mapping of human ABO(H) blood group glycosyltransferases in complex with trisaccharide reaction products suggest a molecular basis for product release.

PubMed

Gagnon, Susannah M L; Legg, Max S G; Sindhuwinata, Nora; Letts, James A; Johal, Asha R; Schuman, Brock; Borisova, Svetlana N; Palcic, Monica M; Peters, Thomas; Evans, Stephen V

2017-10-01

The human ABO(H) blood group A- and B-synthesizing glycosyltransferases GTA and GTB have been structurally characterized to high resolution in complex with their respective trisaccharide antigen products. These findings are particularly timely and relevant given the dearth of glycosyltransferase structures collected in complex with their saccharide reaction products. GTA and GTB utilize the same acceptor substrates, oligosaccharides terminating with α-l-Fucp-(1→2)-β-d-Galp-OR (where R is a glycolipid or glycoprotein), but use distinct UDP donor sugars, UDP-N-acetylgalactosamine and UDP-galactose, to generate the blood group A (α-l-Fucp-(1→2)[α-d-GalNAcp-(1→3)]-β-d-Galp-OR) and blood group B (α-l-Fucp-(1→2)[α-d-Galp-(1→3)]-β-d-Galp-OR) determinant structures, respectively. Structures of GTA and GTB in complex with their respective trisaccharide products reveal a conflict between the transferred sugar monosaccharide and the β-phosphate of the UDP donor. Mapping of the binding epitopes by saturation transfer difference NMR measurements yielded data consistent with the X-ray structural results. Taken together these data suggest a mechanism of product release where monosaccharide transfer to the H-antigen acceptor induces active site disorder and ejection of the UDP leaving group prior to trisaccharide egress. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Review of Online Evidence-based Practice Point-of-Care Information Summary Providers

PubMed Central

Liberati, Alessandro; Moschetti, Ivan; Tagliabue, Ludovica; Moja, Lorenzo

2010-01-01

Background Busy clinicians need easy access to evidence-based information to inform their clinical practice. Publishers and organizations have designed specific tools to meet doctors’ needs at the point of care. Objective The aim of this study was to describe online point-of-care summaries and evaluate their breadth, content development, and editorial policy against their claims of being “evidence-based.” Methods We searched Medline, Google, librarian association websites, and information conference proceedings from January to December 2008. We included English Web-based point-of-care summaries designed to deliver predigested, rapidly accessible, comprehensive, periodically updated, evidence-based information to clinicians. Two investigators independently extracted data on the general characteristics and content presentation of summaries. We assessed and ranked point-of-care products according to: (1) coverage (volume) of medical conditions, (2) editorial quality, and (3) evidence-based methodology. We explored how these factors were associated. Results We retrieved 30 eligible summaries. Of these products, 18 met our inclusion criteria and were qualitatively described, and 16 provided sufficient data for quantitative evaluation. The median volume of medical conditions covered was 80.6% (interquartile range, 68.9% - 84.2%) and varied for the different products. Similarly, differences emerged for editorial policy (median 8.0, interquartile range 5.8 - 10.3) and evidence-based methodology scores (median 10.0, interquartile range 1.0 - 12.8) on a 15-point scale. None of these dimensions turned out to be significantly associated with the other dimensions (editorial quality and volume, Spearman rank correlation r = -0.001, P = .99; evidence-based methodology and volume, r = -0.19, P = .48; editorial and evidence-based methodology, r = 0.43, P =.09). Conclusions Publishers are moving to develop point-of-care summary products. Some of these have better profiles than

Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.

PubMed

Berlowitz, Dan R; Foy, Capri G; Kazis, Lewis E; Bolin, Linda P; Conroy, Molly B; Fitzpatrick, Peter; Gure, Tanya R; Kimmel, Paul L; Kirchner, Kent; Morisky, Donald E; Newman, Jill; Olney, Christine; Oparil, Suzanne; Pajewski, Nicholas M; Powell, James; Ramsey, Thomas; Simmons, Debra L; Snyder, Joni; Supiano, Mark A; Weiner, Daniel E; Whittle, Jeff

2017-08-24

The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment

76 FR 14416 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing. On April 29, 2011, in the morning, the committee will discuss blood donor written statement of... Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors. FDA intends to make background...

Modern banking, collection, compatibility testing and storage of blood and blood components.

PubMed

Green, L; Allard, S; Cardigan, R

2015-01-01

The clinical practice of blood transfusion has changed considerably over the last few decades. The potential risk of transfusion transmissible diseases has directed efforts towards the production of safe and high quality blood. All transfusion services now operate in an environment of ever-increasing regulatory controls encompassing all aspects of blood collection, processing and storage. Stringent donor selection, identification of pathogens that can be transmitted through blood, and development of technologies that can enhance the quality of blood, have all led to a substantial reduction in potential risks and complications associated with blood transfusion. In this article, we will discuss the current standards required for the manufacture of blood, starting from blood collection, through processing and on to storage. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

9 CFR 95.15 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Blood meal, blood albumin, intestines... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.15 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted...

9 CFR 95.15 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Blood meal, blood albumin, intestines... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.15 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted...

9 CFR 95.15 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Blood meal, blood albumin, intestines... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.15 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted...

9 CFR 95.15 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Blood meal, blood albumin, intestines... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.15 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted...

9 CFR 95.15 - Blood meal, blood albumin, intestines, and other animal byproducts for industrial use...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Blood meal, blood albumin, intestines... BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES § 95.15 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted...

Inhibition of peripheral blood neutrophil oxidative burst in periodontitis patients with a homeopathic medication Traumeel S

PubMed Central

žilinskas, Juozas; žekonis, Jonas; žekonis, Gediminas; Šadzevičienė, Renata; Sapragonienė, Marija; Navickaitė, Justina; Barzdžiukaitė, Ingrida

2011-01-01

Summary Background The anti-inflammatory effects of a homeopathic remedy, Traumeel S, have been observed in experimental and clinical studies; however, its antioxidant properties have not been elucidated. The aim of the present study was to evaluate the antioxidant effects of Traumeel S on peripheral blood neutrophils in patients with periodontitis. Material/Methods The study was performed using venous blood of 22 individuals with chronic periodontitis and 21 healthy subjects. The antioxidant effects of Traumeel S on the production of reactive oxygen species by unstimulated and stimulated with unopsonized E. coli neutrophils were investigated using luminol- and lucigenin-dependent chemiluminescence (CL). Results Polymorphonuclear leukocytes of periodontitis patients produced higher levels (p<0.01) of light output of lucigenin-dependent chemiluminescence and significantly reduced (p<0.01) light output of luminol-dependent chemiluminescence than analogous cells of healthy subjects. Highly diluted (10−4 of the stem solution) Traumeel S significantly (by approximately 50%) reduced superoxide-induced oxidation of lucigenin by unstimulated and stimulated with unopsonized E. coli polymorphonuclear leukocytes of periodontitis patients and had a tendency to intensify luminol-dependent chemiluminescence. Preincubation of the unstimulated and stimulated with unopsonized E. coli polymorphonuclear leukocytes of healthy subjects with Traumeel S exerts no inhibitory action on the luminol- and lucigenin-dependent chemiluminescence of the above-mentioned cells. Conclusions This study indicates that Traumeel S may significantly reduce production of superoxide anion by unstimulated and stimulated peripheral blood polymorphonuclear neutrophils of periodontitis patients. PMID:21525811

IRIS TOXICOLOGICAL REVIEW AND SUMMARY ...

EPA Pesticide Factsheets

EPA's assessment of the noncancer health effects and carcinogenic potential of 1,2,3-trichloropropane (TCP) was added to the IRIS database in 1990. The IRIS program is updating the IRIS assessment for TCP. This update will incorporate health effects information published since the last assessment was prepared as well as new risk assessment methods. The IRIS assessment for TCP will consist of a Toxicological Review and IRIS Summary. The Toxicological Review is a critical review of the physicochemical and toxicokinetic properties of the chemical and its toxicity in humans and experimental systems. The assessment will present reference values for noncancer effects of TCP (RfD and RfC) and a cancer assessment. The Toxicological Review and IRIS Summary will be subject to internal peer consultation, Agency review, and external scientific peer review. The final products will constitute the Agency's opinion on the toxicity of TCP. EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for 1,2,3-trichloropropane. IRIS is an EPA database containing the Agency's consensus scientific positions on potential adverse human effects that may result from chronic (or lifetime) exposure to chemicals in the environment. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of two steps of the risk assessment process, i.e., hazard identification and dose-response evaluation. IRIS assessments are used in

IRIS TOXICOLOGICAL REVIEW AND SUMMARY ...

EPA Pesticide Factsheets

Trichloroacetic acid is a crystalline solid with sharp, pungent odor. It is used as a soil sterilizer; and as a laboratory intermediate or reagent in the synthesis of a variety of medicinal products and organic chemicals. Trichloroacetic acid is also used industrially as an etching and pickling agent for the surface treatment of metals and as a solvent in the plastics industry. Trichloroacetic acid can be formed as a combustion byproduct of organic compounds in the presence of chlorine. It is also formed as a disinfection byproduct during water chlorination. The existing IRIS entry was added to the IRIS data base between 1994 and 1996. No RfD was developed. The IRIS program is updating the IRIS assessment for Trichloroacetic Acid. This update will incorporate health effects information published since the last assessment was prepared as well as new risk assessment methods. The IRIS assessment for Trichloroacetic Acid will consist of a Toxicological Review and IRIS Summary. The Toxicological Review is a critical review of the physicochemical and toxicokinetic properties of the chemical and its toxicity in humans and experimental systems. The assessment will present reference value for noncancer effects of Trichloroacetic Acid (RfD) and a cancer assessment. The Toxicological Review and IRIS Summary will be subject to internal peer consultation, Agency review and external scientific peer review. The final products will constitute the Agency's opinion on the

Blood Donation, Payment, and Non-Cash Incentives: Classical Questions Drawing Renewed Interest

PubMed Central

Buyx, Alena M.

2009-01-01

Summary Blood is scarce, and ensuring a sufficient blood supply remains difficult for many countries. Payment for blood as a strategy to increase donations has remained highly controversial for decades, and the debate about ethical issues in paying donors has become somewhat stuck. At least from a policy perspective, it is important to find a compromise which allows for devising and implementing acceptable and successful policies to increase the blood supply. In this paper, such a compromise is developed both from a theoretical and empirical perspective, namely implementing well-designed non-cash incentives which cut across the rigid dichotomy of altruistic donations versus payment for donations. In order for this compromise to work, more attention to donation motives, the choice architecture, and the setting in blood donation needs to be paid. PMID:21076552

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

PubMed Central

Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

2016-01-01

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

Biomonitoring using dried blood spots: Detection of ochratoxin A and its degradation product 2’R‐ochratoxin A in blood from coffee drinkers*

PubMed Central

Cramer, Benedikt; Osteresch, Bernd; Muñoz, Katherine A.; Hillmann, Hartmut; Sibrowski, Walter

2015-01-01

Scope In this study, human exposure to the mycotoxin ochratoxin A (OTA) and its thermal degradation product 2’R‐ochratoxin A (2’R‐OTA, previously named as 14R‐Ochratoxin A [22]) through coffee consumption was assessed. LC‐MS/MS and the dried blood spot (DBS) technique were used for the analysis of blood samples from coffee and noncoffee drinkers (n = 50), and food frequency questionnaires were used to document coffee consumption. Methods and results For the detection of OTA and 2’R‐OTA in blood, a new sensitive and efficient sample preparation method based on DBS was established and validated. Using this technique 2’R‐OTA was for the first time detected in biological samples. Comparison between coffee drinkers and noncoffee drinkers showed for the first time that 2’R‐OTA was only present in blood from the first group while OTA could be found in both groups in a mean concentration of 0.21 μg/L. 2’R‐OTA mean concentration was 0.11 μg/L with a maximum concentration of 0.414 μg/L. Thus, in average 2’R‐OTA was approx. half the concentration of OTA but in some cases even exceeded OTA levels. No correlation between the amounts of coffee consumption and OTA or 2’R‐OTA levels was observed. Conclusion The results of this study revealed for the first time a high exposure of coffee consumers to 2’R‐OTA, a compound formed from OTA during coffee roasting. Since little information is available regarding toxicity and possible carcinogenicity of this compound, further OTA monitoring in blood including 2’R‐OTA is advisable. PMID:26012425

[The added value of information summaries supporting clinical decisions at the point-of-care.

PubMed

Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo

2016-11-01

Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.

Investigation of nanodiamonds interactions in canine blood

NASA Astrophysics Data System (ADS)

WÄ sowicz, Michał; Marek, Kulka; Cićkiewicz, Maciej; Cymerman, Magdalena

2017-02-01

The whole blood contains red cells, white cells, and platelets suspended in plasma. In the following study we investigated an impact of nanodiamond particles on blood elements over various periods of time.The material used in the study consisted of samples taken from ten healthy canines (Canis lupus f. domestica) of various age, different blood types and both sexes. The markings were conducted by adding to the blood unmodified diamonds (SND), modified O2 (SO2) suspended in 0,9% NaCl. The blood was put under an impact of two diamond concentrations: 20μl and 100μl. The amount of abnormal cells increased with time. The percentage of echinocytes as a result of interaction with nanodiamonds in various time periods for individual specimens was scarce. In the examined microscopic image a summary was made for 100 white blood cells. Following cells were included in said group: band neutrophils, segmented neutrophils, eosinophils, basophils, lymphocytes, monocytes, lymphocytes with granulates, stimulated lymphocytes, lymphocytes with vacuoles, metamielocytes and smudge cells. The impact of the three diamond types had no clinical importance on red blood cells. After the diamonds mixed with white blood cells, atypical cells came into being, in the range of agranulocytes in stimulated form or with granulates and/or vacuoles. It is supposed that as a result of longlasting exposure a stimulation and vacuolisation takes place, because of the function of the cells.

Relationship between ketosis and dairy cows' blood metabolites in intensive production farms of the periurban area of Dakar.

PubMed

Yameogo, Nongasida; Ouedraogo, Georges Anicet; Kanyandekwe, Christine; Sawadogo, Germain Jerome

2008-10-01

This study which involved 140 Holstein and Montbeliard was carried out in the periurban area of Dakar with the aim to establish the relationship between ketosis, milk production and biochemical blood metabolites. The results showed that ketosis is a real problem in periurban farms around the city of Dakar with high proportions of 33.57% for subclinical ketosis and 6.43% for clinical ketosis. In their second month of milking, cows with subclinical ketosis had a decrease of 12.4 and 15.,6% in milk yield respectively for Montbeliard and Holstein, whereas cows with clinical ketosis had a decrease of 18.6 and 26%. Ketogenic cows (subclinical and clinical) have significantly lower average levels of blood glucose (p<0.05) and significantly higher average levels of blood urea (p<0.05) than cows with normal blood beta-Hydroxy Butyrate (BbHB) levels. Also, from one farm to another, significant difference was recorded with concentration of total proteins and globulin, calcium and magnesium.

Research Summaries

ERIC Educational Resources Information Center

Brock, Stephen E., Ed.

2011-01-01

This article presents summaries of three articles relevant to school crisis response: (1) "Factors Contributing to Posttraumatic Growth," summarized by Steve DeBlois; (2) "Psychological Debriefing in Cross-Cultural Contexts" (Stacey Rice); and (3) "Brain Abnormalities in PTSD" (Sunny Windingstad). The first summary reports the findings of a…

The Effect of Blood Transfusion on Outcomes in Aortic Surgery.

PubMed

Velasquez, Camilo A; Singh, Mrinal; Bin Mahmood, Syed Usman; Brownstein, Adam J; Zafar, Mohammad A; Saeyeldin, Ayman; Ziganshin, Bulat A; Elefteriades, John A

2017-09-01

The use of blood transfusion in cardiac surgery varies widely. The beneficial effects of blood products are offset by an increase in morbidity and mortality. Despite multiple studies showing an association between blood product exposure and adverse short- and long-term events, it is difficult to determine causality. Nevertheless, the implication is sufficient to warrant the search for alternative strategies to reduce the use of blood products while providing a standard of care that optimizes postoperative outcomes. Aortic surgery, in particular, is associated with an increased risk of bleeding requiring a blood transfusion. There is a paucity of evidence within aortic surgery regarding the deleterious effects of blood products. Here, we review the current evidence regarding patient outcomes after blood transfusion in cardiac surgery, with special emphasis on aortic surgery.

Generation Y and Blood Donation: The Impact of Altruistic Help in a Darwiportunistic Scenario

PubMed Central

Scholz, Christian

2010-01-01

Summary This article focuses on the members of Generation Y and their willingness to offer voluntary (unpaid) blood donations. Using statistics from various sources, a three-stage model is developed to explain blood donation behaviour especially of this generation. It consists of i) developing altruism, ii) raising the willingness to donate blood, and iii) activating actual blood donation behaviour. Members of Generation Y live in a Darwinistic society. They also to some degree act opportunistically, but not in contradiction to altruism. For that reason, the article positions itself in the theoretical framework of Darwi-portunism and derives practical suggestions as well as implications for research. PMID:21048826

Use of spray-dried porcine blood by-products in diets for young chickens.

PubMed

Jamroz, D; Wiliczkiewicz, A; Orda, J; Kuryszko, J; Stefaniak, T

2012-04-01

Spray-dried porcine blood plasma (SDBP) or blood cells (SDBC) at amounts of 20 or 40 g/kg were included to the feed mixtures that were given to young chickens within 1-28 (Exp. 1) or 1-30 (Exp. 2) days post-hatch. In comparison with the group fed mixtures containing plant components, chickens fed mixtures supplemented with 40 g/kg of SDBP significantly (p < 0.01) increased the body weight estimated on 14 day of life (Exp. 1). At the age of 28 or 30 days post-hatch, the body weight was improved significantly (p < 0.01 or 0.05) in both experiments. Significant differences (one-factorial anova) in feed conversion among particular feeding groups were stated in Exp. 1 only; however, calculations using two-factorial anova show insignificant differences depending on the used animal meal. In selected blood parameters (IgG, Ht, Hb), insignificant differences between feeding groups were stated. The use of SDBP in feed mixture significantly increased the Na retention in both experiments, and K accretion in Exp. 1 only. Application of SDBC and 40 g/kg of SDBP significantly or insignificantly improved Fe retention. Insignificant diversification of apparent ileal digestibility of nutrients was stated; the crude fat was significantly better digested in treatments fed mixtures with animal meals but kind of animal meal was without any significant effect. Significant differences in digestibility of amino acids were recorded for Pro, Cys, Val, His, Lys and Arg. In chickens fed mixture with SDBC, higher coefficients of apparent digestibility of Cys, Val and His (Exp. 1) and Cys and His (Exp. 2) than in other feeding groups were obtained. The kind of used blood by-products has not affected the histological structure of intestine wall. © 2011 Blackwell Verlag GmbH.

Automated processing of whole blood units: operational value and in vitro quality of final blood components

PubMed Central

Jurado, Marisa; Algora, Manuel; Garcia-Sanchez, Félix; Vico, Santiago; Rodriguez, Eva; Perez, Sonia; Barbolla, Luz

2012-01-01

Background The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. Materials and methods Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. Results The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. Discussion These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement. PMID:22044958

Automated processing of whole blood units: operational value and in vitro quality of final blood components.

PubMed

Jurado, Marisa; Algora, Manuel; Garcia-Sanchez, Félix; Vico, Santiago; Rodriguez, Eva; Perez, Sonia; Barbolla, Luz

2012-01-01

The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement.

Blood Products and the Commodification Debate: The Blurry Concept of Altruism and the 'Implicit Price' of Readily Available Body Parts.

PubMed

Dufner, Annette

2015-12-01

There is a widespread consensus that a commodification of body parts is to be prevented. Numerous policy papers by international organizations extend this view to the blood supply and recommend a system of uncompensated volunteers in this area--often, however, without making the arguments for this view explicit. This situation seems to indicate that a relevant source of justified worry or unease about the blood supply system has to do with the issue of commodification. As a result, the current health minister of Ontario is proposing a ban on compensation even for blood plasma--despite the fact that Canada can only generate 30 % of the plasma needed for fractionation into important plasma protein products and has to purchase the rest abroad. In the following, I am going to suggest a number of alternative perspectives on the debate in order to facilitate a less dogmatic and more differentiated debate about the matter. Especially in light of the often over-simplified notions of altruism and commodification, I conclude that the debate has not conclusively established that it would be morally objectionable to provide blood plasma donors with monetary compensation or with other forms of explicit social recognition as an incentive. This is especially true of donations for fractionation into medicinal products by profit-oriented pharmaceutical companies.

Blood in ancient Jewish culture.

PubMed

Kottek, Samuel S

2005-01-01

The article analyzes the Jewish attitude towards blood, conceived both as the vehicle of life, and as a polluting product of feminine bodies. The author analyzes numerous Biblical sources concerning the 'unapproachable' blood of menstruation, the role of blood in the generation of the fetus, the blood as source of illness, the practice of bloodletting, and finally the idea that male menstruation exists as a peculiarity of the Jews.

Prosocial Motivation and Blood Donations: A Survey of the Empirical Literature

PubMed Central

Goette, Lorenz; Stutzer, Alois; Frey, Beat M.

2010-01-01

Summary Recent shortages in the supply of blood donations have renewed the interest in how blood donations can be increased temporarily. We survey the evidence on the role of financial and other incentives in eliciting blood donations among donors who are normally willing to donate pro bono. We present the predictions from different empirical/psychological-based theories, with some predicting that incentives are effective while others predict that incentives may undermine prosocial motivation. The evidence suggests that incentives work relatively well in settings in which donors are relatively anonymous, but evidence indicates also that when image concerns become important, incentives may be counterproductive as donors do not want to be seen as greedy. PMID:20737018

Interspecific correlation between red blood cell mitochondrial ROS production, cardiolipin content and longevity in birds.

PubMed

Delhaye, Jessica; Salamin, Nicolas; Roulin, Alexandre; Criscuolo, François; Bize, Pierre; Christe, Philippe

2016-12-01

Mitochondrial respiration releases reactive oxygen species (ROS) as by-products that can damage the soma and may in turn accelerate ageing. Hence, according to "the oxidative stress theory of ageing", longer-lived organisms may have evolved mechanisms that improve mitochondrial function, reduce ROS production and/or increase cell resistance to oxidative damage. Cardiolipin, an important mitochondrial inner-membrane phospholipid, has these properties by binding and stabilizing mitochondrial inner-membrane proteins. Here, we investigated whether ROS production, cardiolipin content and cell membrane resistance to oxidative attack in freshly collected red blood cells (RBCs) are associated with longevity (range 5-35 years) in 21 bird species belonging to seven Orders. After controlling for phylogeny, body size and oxygen consumption, variation in maximum longevity was significantly explained by mitochondrial ROS production and cardiolipin content, but not by membrane resistance to oxidative attack. RBCs of longer-lived species produced less ROS and contained more cardiolipin than RBCs of shorter-lived species did. These results support the oxidative stress theory of ageing and shed light on mitochondrial cardiolipin as an important factor linking ROS production to longevity.

Fermented Soy Product Intake Is Inversely Associated with the Development of High Blood Pressure: The Japan Public Health Center-Based Prospective Study.

PubMed

Nozue, Miho; Shimazu, Taichi; Sasazuki, Shizuka; Charvat, Hadrien; Mori, Nagisa; Mutoh, Michihiro; Sawada, Norie; Iwasaki, Motoki; Yamaji, Taiki; Inoue, Manami; Kokubo, Yoshihiro; Yamagishi, Kazumasa; Iso, Hiroyasu; Tsugane, Shoichiro

2017-09-01

Background: Randomized controlled studies have investigated the short-term effect of soy product intake on blood pressure (BP) in normotensive people. To our knowledge, no prospective studies exist on the effect of habitual intake of fermented soy products, separate from total soy products, on BP in the general population. Objective: We examined the association between the habitual intake of soy products, including fermented soy products, and the development of high BP during a 5-y period among participants in a population-based prospective cohort study in Japan. Methods: The study included normotensive participants aged 40-69 y at baseline (926 men and 3239 women) who completed 2 questionnaires and whose BP was measured at the baseline survey between 1993 and 1994 and the 5-y follow-up in the Japan Public Health Center-Based Prospective Study Cohort II. The intake of soy products was assessed with a food-frequency questionnaire. High BP was defined as systolic blood pressure ≥130 mm Hg, diastolic blood pressure ≥85 mm Hg, or antihypertensive medication use. ORs and 95% CIs of high BP by frequency of soy products (miso, natto, and tofu) consumption, intake of total and fermented soy products, and intake of isoflavones from total and fermented soy products were estimated with the use of multiple logistic regression analysis. Results: Multivariable-adjusted ORs of high BP for the highest compared with the lowest tertile of total and fermented soy product intake were 1.03 (95% CI: 0.84, 1.25; P -trend = 0.786) and 0.72 (95% CI: 0.56, 0.92; P -trend = 0.009), respectively. The frequency of nonfermented soy product (tofu) intake was not associated with the development of high BP ( P -trend = 0.597). Conclusions: The intake of fermented soy products, but not total or nonfermented soy products, was inversely associated with developing high BP in men and women with normal BP. © 2017 American Society for Nutrition.

Neutrophil extracellular trap formation is increased in psoriasis and induces human β-defensin-2 production in epidermal keratinocytes

PubMed Central

Hu, Stephen Chu-Sung; Yu, Hsin-Su; Yen, Feng-Lin; Lin, Chi-Ling; Chen, Gwo-Shing; Lan, Cheng-Che E.

2016-01-01

Neutrophil extracellular traps (NETs) have been implicated in the development of certain immune-mediated diseases, but their role in psoriasis has not been clearly defined. Human β-defensin-2 (HBD-2) is an important antimicrobial peptide overexpressed in psoriasis epidermis. We evaluated whether the amount of NETs is increased in psoriasis and determined the effect of NETs on HBD-2 production in epidermal keratinocytes. Using fluorescent microscopy, we found that patients with psoriasis (n = 48) had higher amount of NETotic cells in their peripheral blood compared to healthy controls (n = 48) and patients with eczema (n = 35). Psoriasis sera showed increased ability to induce NET formation in control neutrophils but normal NET degradation ability. The amount of NETs in the peripheral blood correlated with psoriasis disease severity. NETosis was also observed in the majority (18 of 20) of psoriasis skin specimens. Furthermore, NETs induced HBD-2 mRNA and protein production in keratinocytes, and immunohistochemical analysis confirmed strong expression of HBD-2 in psoriasis lesional skin. In summary, NET formation is increased in peripheral blood and lesional skin of psoriasis patients and correlates with disease severity. Additionally, NET-induced HBD-2 production may provide a novel mechanism for the decreased susceptibility of psoriasis plaques to microbial infections. PMID:27493143

Does blood transfusion affect intermediate survival after coronary artery bypass surgery?

PubMed

Mikkola, R; Heikkinen, J; Lahtinen, J; Paone, R; Juvonen, T; Biancari, F

2013-01-01

The aim of this study was to investigate the impact of transfusion of blood products on intermediate outcome after coronary artery bypass surgery. Complete data on perioperative blood transfusion in patients undergoing coronary artery bypass surgery were available from 2001 patients who were operated at our institution. Transfusion of any blood product (relative risk = 1.678, 95% confidence interval = 1.087-2.590) was an independent predictor of all-cause mortality. The additive effect of each blood product on all-cause mortality (relative risk = 1.401, 95% confidence interval = 1.203-1.630) and cardiac mortality (relative risk = 1.553, 95% confidence interval = 1.273-1.895) was evident when the sum of each blood product was included in the regression models. However, when single blood products were included in the regression model, transfusion of fresh frozen plasma/Octaplas® was the only blood product associated with increased risk of all-cause mortality (relative risk = 1.692, 95% confidence interval = 1.222-2.344) and cardiac mortality (relative risk = 2.125, 95% confidence interval = 1.414-3.194). The effect of blood product transfusion was particularly evident during the first three postoperative months. Since follow-up was truncated at 3 months, transfusion of any blood product was a significant predictor of all-cause mortality (relative risk = 2.998, 95% confidence interval = 1.053-0.537). Analysis of patients who survived or had at least 3 months of potential follow-up showed that transfusion of any blood product was not associated with a significantly increased risk of intermediate all-cause mortality (relative risk = 1.430, 95% confidence interval = 0.880-2.323). Transfusion of any blood product is associated with a significant risk of all-cause and cardiac mortality after coronary artery bypass surgery. Such a risk seems to be limited to the early postoperative period and diminishes later on. Among blood products, perioperative use of fresh frozen

Hormones that Stimulate the Growth of Blood Cells.

ERIC Educational Resources Information Center

Golde, David W.; Gasson, Judith C.

1988-01-01

Describes the nature and action of hematopoietic proteins which regulate the production of specific sets of blood cells. Discusses the production of these hematopoietins by recombinant-DNA methods in an effort to enable physicians to treat patients by eliciting production of specific types of blood cells. (CW)

Revaluing donor and recipient bodies in the globalised blood economy: transitions in public policy on blood safety in the United Kingdom.

PubMed

Busby, Helen; Kent, Julie; Farrell, Anne-Maree

2014-01-01

The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on 'tissue economies'. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies.

RFID in the blood supply chain--increasing productivity, quality and patient safety.

PubMed

Briggs, Lynne; Davis, Rodeina; Gutierrez, Alfonso; Kopetsky, Matthew; Young, Kassandra; Veeramani, Raj

2009-01-01

As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions.

Effects of zilpaterol hydrochloride on methane production, total body oxygen consumption, and blood metabolites in finishing beef steers

USDA-ARS?s Scientific Manuscript database

An indirect calorimetry experiment was conducted to determine the effects of feeding zilpaterol hydrochloride (ZH) for 20 d on total body oxygen consumption, respiratory quotient, methane production, and blood metabolites in finishing beef steers. Sixteen Angus steers (initial BW = 555 ± 12.7 kg) w...

Central and peripheral blood pressures in relation to plasma advanced glycation end products in a Chinese population.

PubMed

Huang, Q-F; Sheng, C-S; Kang, Y-Y; Zhang, L; Wang, S; Li, F-K; Cheng, Y-B; Guo, Q-H; Li, Y; Wang, J-G

2016-07-01

We investigated the association of plasma AGE (advanced glycation end product) concentration with central and peripheral blood pressures and central-to-brachial blood pressure amplification in a Chinese population. The study subjects were from a newly established residential area in the suburb of Shanghai. Using the SphygmoCor system, we recorded radial arterial waveforms and derived aortic waveforms by a generalized transfer function and central systolic and pulse pressure by calibration for brachial blood pressure measured with an oscillometric device. The central-to-brachial pressure amplification was expressed as the central-to-brachial systolic blood pressure difference and pulse pressure difference and ratio. Plasma AGE concentration was measured by the enzyme-linked immunosorbent assay method and logarithmically transformed for statistical analysis. The 1051 participants (age, 55.1±13.1 years) included 663 women. After adjustment for sex, age and other confounding factors, plasma AGE concentration was associated with central but not peripheral blood pressures and with some of the pressure amplification indexes. Indeed, each 10-fold increase in plasma AGE concentration was associated with 2.94 mm Hg (P=0.04) higher central systolic blood pressure and 2.39% lower central-to-brachial pulse pressure ratio (P=0.03). In further subgroup analyses, the association was more prominent in the presence of hypercholesterolemia (+8.11 mm Hg, P=0.008) for central systolic blood pressure and in the presence of overweight and obesity (-4.89%, P=0.009), diabetes and prediabetes (-6.26%, P=0.10) or current smoking (-6.68%, P=0.045) for central-to-brachial pulse pressure ratio. In conclusion, plasma AGE concentration is independently associated with central systolic blood pressure and pulse pressure amplification, especially in the presence of several modifiable cardiovascular risk factors.

Quality Assessment of Established and Emerging Blood Components for Transfusion

PubMed Central

Marks, Denese C.

2016-01-01

Blood is donated either as whole blood, with subsequent component processing, or through the use of apheresis devices that extract one or more components and return the rest of the donation to the donor. Blood component therapy supplanted whole blood transfusion in industrialized countries in the middle of the twentieth century and remains the standard of care for the majority of patients receiving a transfusion. Traditionally, blood has been processed into three main blood products: red blood cell concentrates; platelet concentrates; and transfusable plasma. Ensuring that these products are of high quality and that they deliver their intended benefits to patients throughout their shelf-life is a complex task. Further complexity has been added with the development of products stored under nonstandard conditions or subjected to additional manufacturing steps (e.g., cryopreserved platelets, irradiated red cells, and lyophilized plasma). Here we review established and emerging methodologies for assessing blood product quality and address controversies and uncertainties in this thriving and active field of investigation. PMID:28070448

21 CFR 640.23 - Testing the blood.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Testing the blood. 640.23 Section 640.23 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Platelets § 640.23 Testing the blood. (a) Blood from... this chapter and § 640.5 (a), (b), and (c). (b) The tests shall be performed on a sample of blood...

21 CFR 640.23 - Testing the blood.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Testing the blood. 640.23 Section 640.23 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Platelets § 640.23 Testing the blood. (a) Blood from... this chapter and § 640.5 (a), (b), and (c). (b) The tests shall be performed on a sample of blood...

21 CFR 640.23 - Testing the blood.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Testing the blood. 640.23 Section 640.23 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Platelets § 640.23 Testing the blood. (a) Blood from... this chapter and § 640.5 (a), (b), and (c). (b) The tests shall be performed on a sample of blood...

21 CFR 640.23 - Testing the blood.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Testing the blood. 640.23 Section 640.23 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Platelets § 640.23 Testing the blood. (a) Blood from... this chapter and § 640.5 (a), (b), and (c). (b) The tests shall be performed on a sample of blood...

21 CFR 640.5 - Testing the blood.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Testing the blood. 640.5 Section 640.5 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.5 Testing the blood. All laboratory tests shall be made on a specimen of blood taken from the donor at the time of collecting the unit of...

21 CFR 640.5 - Testing the blood.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Testing the blood. 640.5 Section 640.5 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.5 Testing the blood. All laboratory tests shall be made on a specimen of blood taken from the donor at the time of collecting the unit of...

21 CFR 640.5 - Testing the blood.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Testing the blood. 640.5 Section 640.5 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.5 Testing the blood. All laboratory tests shall be made on a specimen of blood taken from the donor at the time of collecting the unit of...

21 CFR 640.5 - Testing the blood.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Testing the blood. 640.5 Section 640.5 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Whole Blood § 640.5 Testing the blood. All laboratory tests shall be made on a specimen of blood taken from the donor at the time of collecting the unit of...

21 CFR 640.23 - Testing the blood.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Testing the blood. 640.23 Section 640.23 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Platelets § 640.23 Testing the blood. (a) Blood from... this chapter and § 640.5 (a), (b), and (c). (b) The tests shall be performed on a sample of blood...

Effects of intravenous delivery systems on infused red blood cells.

PubMed

Gibson, J S; Leff, R D; Roberts, R J

1984-03-01

The effects of various intravenous delivery systems on the integrity of infused red blood cells (RBCs) were studied. Using a factorial design, whole blood and packed RBCs were infused through i.v. delivery systems employing various combinations of i.v. tubing diameter and length, needle gauge, infusion rate (5 and 50 ml/hr), type of infusion pump (piston, diaphragm, or peristaltic operation), and type of blood product. The age and temperature of the blood filter used were held constant. A 5-ml sample of the blood product obtained during each experimental run was analyzed for plasma free-hemoglobin to assess the degree of hemolysis. Osmotic fragility of the RBCs was evaluated by measuring the percentage of hemolysis in the blood products in various concentrations of sodium chloride solution. Type of blood product and i.v. pump were the only variables significantly influencing RBC hemolysis. In both blood products, a greater degree of hemolysis occurred with the peristaltic-type pump than with the other types of pumps. In packed RBCs, the diaphragm-type pump produced greater hemolysis than the piston-type pump, but hemolysis was similar in whole-blood samples. Regardless of the type of pump, more hemolysis occurred in whole blood at the 5-ml/hr infusion rate than at the 50-ml/hr rate, but the converse was true in packed RBCs. Samples of both blood products were less osmotically fragile than their respective controls at sodium chloride concentrations ranging from 0.30 to 0.50%.(ABSTRACT TRUNCATED AT 250 WORDS)

Determination of personal care products -benzophenones and parabens- in human menstrual blood.

PubMed

Jiménez-Díaz, I; Iribarne-Durán, L M; Ocón, O; Salamanca, E; Fernández, M F; Olea, N; Barranco, E

2016-11-01

Benzophenones and parabens are synthetic chemicals used in many personal care products, foods and pharmaceuticals. Benzophenones are used to protect the skin and materials from the adverse effects of UV-radiation, and parabens are used as preservatives. Despite their widespread occurrence and proven endocrine disrupting activity, relatively little is known about human exposure to these compounds. In the present work, an analytical method based on sample treatment using dispersive liquid-liquid microextraction (DLLME) for the extraction of six benzophenones (benzophenone-1, -2, -3, -6, -8 and 4-hydroxybenzophenone) and four parabens (methyl-, ethyl-, propyl- and butyl- paraben) from human menstrual blood samples, followed by ultrahigh performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) analysis, is proposed and validated. The method was validated using matrix-matched standard calibration followed by a recovery assay with spiked samples. The limits of detection ranged from 0.1 to 0.3ngmL -1 , with recoveries of 93.8% to 108.9%, and precision (evaluated as relative standard deviation) lower than 14% for all selected compounds. This method was successfully applied for the determination of the target compounds in 25 samples of human menstrual blood. Methylparaben and benzophenone-3 were the most frequently detected compounds (96%). Copyright © 2016 Elsevier B.V. All rights reserved.

More milk from forage: Milk production, blood metabolites, and forage intake of dairy cows grazing pasture mixtures and spatially adjacent monocultures.

PubMed

Pembleton, Keith G; Hills, James L; Freeman, Mark J; McLaren, David K; French, Marion; Rawnsley, Richard P

2016-05-01

There is interest in the reincorporation of legumes and forbs into pasture-based dairy production systems as a means of increasing milk production through addressing the nutritive value limitations of grass pastures. The experiments reported in this paper were undertaken to evaluate milk production, blood metabolite concentrations, and forage intake levels of cows grazing either pasture mixtures or spatially adjacent monocultures containing perennial ryegrass (Lolium perenne), white clover (Trifolium repens), and plantain (Plantago lanceolata) compared with cows grazing monocultures of perennial ryegrass. Four replicate herds, each containing 4 spring-calving, cross-bred dairy cows, grazed 4 different forage treatments over the periods of early, mid, and late lactation. Forage treatments were perennial ryegrass monoculture (PRG), a mixture of white clover and plantain (CPM), a mixture of perennial ryegrass, white clover, and plantain (RCPM), and spatially adjacent monocultures (SAM) of perennial ryegrass, white clover, and plantain. Milk volume, milk composition, blood fatty acids, blood β-hydroxybutyrate, blood urea N concentrations, live weight change, and estimated forage intake were monitored over a 5-d response period occurring after acclimation to each of the forage treatments. The acclimation period for the early, mid, and late lactation experiments were 13, 13, and 10 d, respectively. Milk yield (volume and milk protein) increased for cows grazing the RCPM and SAM in the early lactation experiment compared with cows grazing the PRG, whereas in the mid lactation experiment, milk fat increased for the cows grazing the RCPM and SAM when compared with the PRG treatments. Improvements in milk production from grazing the RCPM and SAM treatments are attributed to improved nutritive value (particularly lower neutral detergent fiber concentrations) and a potential increase in forage intake. Pasture mixtures or SAM containing plantain and white clover could be a

Particle swarm optimization algorithm for optimizing assignment of blood in blood banking system.

PubMed

Olusanya, Micheal O; Arasomwan, Martins A; Adewumi, Aderemi O

2015-01-01

This paper reports the performance of particle swarm optimization (PSO) for the assignment of blood to meet patients' blood transfusion requests for blood transfusion. While the drive for blood donation lingers, there is need for effective and efficient management of available blood in blood banking systems. Moreover, inherent danger of transfusing wrong blood types to patients, unnecessary importation of blood units from external sources, and wastage of blood products due to nonusage necessitate the development of mathematical models and techniques for effective handling of blood distribution among available blood types in order to minimize wastages and importation from external sources. This gives rise to the blood assignment problem (BAP) introduced recently in literature. We propose a queue and multiple knapsack models with PSO-based solution to address this challenge. Simulation is based on sets of randomly generated data that mimic real-world population distribution of blood types. Results obtained show the efficiency of the proposed algorithm for BAP with no blood units wasted and very low importation, where necessary, from outside the blood bank. The result therefore can serve as a benchmark and basis for decision support tools for real-life deployment.

Revaluing donor and recipient bodies in the globalised blood economy: Transitions in public policy on blood safety in the United Kingdom

PubMed Central

Kent, Julie; Farrell, Anne-Maree

2014-01-01

The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on ‘tissue economies’. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies. PMID:23467898

Development of a Cancer Care Summary Through the Electronic Health Record.

PubMed

Carr, Laurie L; Zelarney, Pearlanne; Meadows, Sarah; Kern, Jeffrey A; Long, M Bronwyn; Kern, Elizabeth

2016-02-01

Our objective was to improve communication concerning lung cancer patients by developing and distributing a Cancer Care Summary that would provide clinically useful information about the patient's diagnosis and care to providers in diverse settings. We designed structured, electronic forms for the electronic health record (EHR), detailing tumor staging, classification, and treatment. To ensure completeness and accuracy of the information, we implemented a data quality cycle, composed of reports that are reviewed by oncology clinicians. The data from the EHR forms are extracted into a structured query language database system on a daily basis, from which the Summaries are derived. We conducted focus groups regarding the utility, format, and content of the Summary. Cancer Care Summaries are automatically generated 4 months after a patient's date of diagnosis, then every 6 months for those receiving treatment, and on an as-needed basis for urgent care or hospital admission. The product of our improvement project is the Cancer Care Summary. To date, 102 individual patient Summaries have been generated. These documents are automatically entered into the National Jewish Health (NJH) EHR, attached to correspondence to primary care providers, available to patients as electronic documents on the NJH patient portal, and faxed to emergency departments and admitting physicians on patient evaluation. We developed a sustainable tool to improve cancer care communication. The Cancer Care Summary integrates information from the EHR in a timely manner and distributes the information through multiple avenues. Copyright © 2016 by American Society of Clinical Oncology.

Pathogen reduction of blood components.

PubMed

Solheim, Bjarte G

2008-08-01

Thanks to many blood safety interventions introduced in developed countries the risk of transfusion transmitted infections has become exceedingly small in these countries. However, emerging pathogens still represent a serious challenge, as demonstrated by West Nile virus in the US and more recently by Chikungunya virus in the Indian Ocean. In addition bacterial contamination, particularly in platelets, and protozoa transmitted by blood components still represent sizeable risks in developed countries. In developing countries the risk of all transfusion transmitted infections is still high due to insufficient funding and organisation of the health service. Pathogen reduction of pooled plasma products has virtually eliminated the risk of transfusion transmitted infections, without compromising the quality of the products significantly. Pathogen reduction of blood components has been much more challenging. Solvent detergent treatment which has been so successfully applied for plasma products dissolves cell membranes, and can, therefore, only be applied for plasma and not for cellular blood components. Targeting of nucleic acids has been another method for pathogen inactivation of plasma and the only approach possible for cellular blood products. As documented in more than 15 year's track record, solvent detergent treatment of pooled plasma can yield high quality plasma. The increased risk for contamination by unknown viruses due to pooling is out weighed by elimination of TRALI, significant reduction in allergic reactions and standardisation of the product. Recently, a promising method for solvent detergent treatment of single donor plasma units has been published. Methylene blue light treatment of single donor plasma units has a similar long track record as pooled solvent detergent treated plasma; but the method is less well documented and affects coagulation factor activity more. Psoralen light treated plasma has only recently been introduced (CE marked in Europe

Lack of effects of a "sobering" product, "Eezup!", on the blood ethanol and congener alcohol concentration.

PubMed

Wunder, Cora; Hain, Sarah; Koelzer, Sarah C; Paulke, Alexander; Verhoff, Marcel A; Toennes, Stefan W

2017-09-01

The lifestyle product 'Eezup!' appeared on the German market and promised to normalize energy metabolism. Among vitamins (B 1 , B 2 , B 6 , C, E and zinc), rice protein and fructose the addition of alcohol dehydrogenase and catalase enzymes is a novel approach. The product was advertised as capable of boosting the rate of alcohol elimination. Seventeen subjects (11 men, 6 women, 19-58 years old), participated in a two-way crossover drinking study. Unfiltered wheat beer (4.4g% alcohol content) was drank within one hour to reach blood alcohol concentrations of 1‰ (1g/kg whole blood). On one day "Eezup!" was taken according to the manufacturer's instructions before and after drinking which was substituted for a placebo on the second test day. Blood samples were taken during 9h and ethanol and congener alcohols were determined. A comparison of C max , t max , area under the curve (AUC) for ethanol and congener alcohols, and the hourly elimination rate of ethanol (β 60 ) was performed to investigate an effect of Eezup!. Ethanol concentrations (Cmax) were in the range of 0,63-1,00‰ (median 0,85‰) and 0.62-1.22‰ (median 0.84‰) in the placebo and "Eezup!" condition, respectively, and not statistically different. Also t max (1-2.5h) and AUCs did not differ. The ethanol elimination rates were 0.16‰/h (0.14-0.19‰/h) and 0.17‰/h (0.14-0.22 ‰/h) in the placebo and "Eezup!" condition without significant difference. The pharmacokinetic parameters of the congener alcohols (1-propanol, isobutanol, 3-methyl-1-butanol, 2-methyl-1-butanol) as well as of methanol did also not differ. The results of the present study failed to show any effect of the sobering product "Eezup!" on the amount of ethanol and congener alcohols absorbed (C max , t max, AUC) and on the ethanol elimination rate (β 60 ). Copyright © 2017 Elsevier B.V. All rights reserved.

Do evidence summaries increase policy-makers' use of evidence from systematic reviews: A systematic review protocol.

PubMed

Petkovic, Jennifer; Welch, Vivian; Tugwell, Peter

2015-09-28

Systematic reviews are important for decision-makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which makes them hard to use for decision-making. There are many organizations that develop and disseminate derivative products, such as evidence summaries, from systematic reviews for different populations or subsets of decision-makers. This systematic review will assess the effectiveness of systematic review summaries on increasing policymakers' use of systematic review evidence and to identify the components or features of these summaries that are most effective. We will include studies of policy-makers at all levels as well as health-system managers. We will include studies examining any type of "evidence summary," "policy brief," or other products derived from systematic reviews that present evidence in a summarized form. The primary outcomes are the following: (1) use of systematic review summaries decision-making (e.g., self-reported use of the evidence in policy-making, decision-making) and (2) policy-maker understanding, knowledge, and/or beliefs (e.g., changes in knowledge scores about the topic included in the summary). We will conduct a systematic review of randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), controlled before-after studies (CBA), and interrupted time series (ITS) studies. The results of this review will inform the development of future systematic review summaries to ensure that systematic review evidence is accessible to and used by policy-makers making health-related decisions.

Surface-enhanced Raman scattering of whole human blood, blood plasma, and red blood cells: cellular processes and bioanalytical sensing.

PubMed

Premasiri, W R; Lee, J C; Ziegler, L D

2012-08-09

SERS spectra of whole human blood, blood plasma, and red blood cells on Au nanoparticle SiO(2) substrates excited at 785 nm have been observed. For the sample preparation procedure employed here, the SERS spectrum of whole blood arises from the blood plasma component only. This is in contrast to the normal Raman spectrum of whole blood excited at 785 nm and open to ambient air, which is exclusively due to the scattering of oxyhemoglobin. The SERS spectrum of whole blood shows a storage time dependence that is not evident in the non-SERS Raman spectrum of whole blood. Hypoxanthine, a product of purine degradation, dominates the SERS spectrum of blood after ~10-20 h of storage at 8 °C. The corresponding SERS spectrum of plasma isolated from the stored blood shows the same temporal release of hypoxanthine. Thus, blood cellular components (red blood cells, white blood cells, and/or platelets) are releasing hypoxanthine into the plasma over this time interval. The SERS spectrum of red blood cells (RBCs) excited at 785 nm is reported for the first time and exhibits well-known heme group marker bands as well as other bands that may be attributed to cell membrane components or protein denaturation contributions. SERS, as well as normal Raman spectra, of oxy- and met-RBCs are reported and compared. These SERS results can have significant impact in the area of clinical diagnostics, blood supply management, and forensics.

Surface Enhanced Raman Scattering of Whole Human Blood, Blood Plasma and Red Blood Cells: Cellular Processes and Bioanalytical Sensing

PubMed Central

Premasiri, W. R.; Lee, J. C.; Ziegler, L. D.

2013-01-01

SERS spectra of whole human blood, blood plasma and red blood cells on Au nanoparticle SiO2 substrates excited at 785 nm have been observed. For the sample preparation procedure employed here, the SERS spectrum of whole blood arises from the blood plasma component only. This is in contrast to the normal Raman spectrum of whole blood excited at 785 nm and open to ambient air, which is exclusively due to the scattering of oxyhemoglobin. The SERS spectrum of whole blood shows a storage time dependence that is not evident in the non-SERS Raman spectrum of whole blood. Hypoxanthine, a product of purine degradation, dominates the SERS spectrum of blood after ~10 – 20 hours of storage at 8 °C. The corresponding SERS spectrum of plasma isolated from the stored blood shows the same temporal release of hypoxanthine. Thus, blood cellular components (red blood cells, white blood cells and/or platelets) are releasing hypoxanthine into the plasma over this time interval. The SERS spectrum of red blood cells (RBCs) excited at 785 nm is reported for the first time and exhibits well known heme group marker bands, as well as other bands that may be attributed to cell membrane components or protein denaturation contributions. SERS, as well as normal Raman spectra, of oxy- and met-RBCs are reported and compared. These SERS results can have significant impact in the area of clinical diagnostics, blood supply management and forensics. PMID:22780445

Blood pressure monitoring: theory and practice. European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability Teaching Course Proceedings.

PubMed

Stergiou, George S; Palatini, Paolo; Asmar, Roland; Bilo, Grzegorz; de la Sierra, Alejandro; Head, Geoff; Kario, Kazuomi; Mihailidou, Anastasia; Wang, Jiguang; Mancia, Giuseppe; O'Brien, Eoin; Parati, Gianfranco

2018-02-01

The European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and Cardiovascular Variability organized a Teaching Course on 'Blood Pressure Monitoring: Theory and Practice' during the 2017 ESH Meeting in Milan, Italy. This course performed by 11 international BP monitoring experts covered key topics of BP monitoring, including office BP measurement, ambulatory BP monitoring, home BP monitoring, ambulatory versus home BP, white-coat and masked hypertension, cuff use, and BP variability. This article presents a summary of the proceedings of the ESH BP Monitoring Teaching Course, including essential information, practical issues, and recommendations on the clinical application of BP monitoring methods, aiming to the optimal management of patients with suspected or diagnosed hypertension.

Transfusion safety: is this the business of blood centers?

PubMed

Slapak, Colleen; Fredrich, Nanci; Wagner, Jeffrey

2011-12-01

ATSO is in a unique position to break down organizational silos between hospitals and blood centers through the development of a collaborative relationship between the two entities. Use of the TSO as blood center staff centralizes the role into a consultative position thereby retaining the independence of the hospitals. The TSO position then becomes a value-added service offered by the blood center designed to supplement processes within the hospital.Whether the TSO is based in the hospital or the blood center, improvements are gained through appropriate utilization of blood components, reductions in hospital costs, ongoing education of hospital staff involved in transfusion practice, and increased availability of blood products within the community. Implementation and standardization of best practice processes for ordering and administration of blood products developed by TSOs leads to improved patient outcomes. As a liaison between hospitals and blood centers, the TSO integrates the mutual goal of transfusion safety: the provision of the safest blood product to the right patient at the right time for the right reason.

Effects of blood type and blood handling on feeding success, longevity and egg production in the body louse, Pediculus humanus humanus.

PubMed

Mumcuoglu, K Y; Danilevich, M; Zelig, O; Grinbaum, H; Friger, M; Meinking, T L

2011-03-01

The effects of feeding different types of human blood to human body lice, Pediculus humanus humanus L. (Phthiraptera: Pediculidae), on feeding success, longevity and numbers of eggs laid were investigated using an artificial blood-feeding system in the laboratory. No significant differences were found between lice fed on different human blood types for any of the parameters tested. However, when lice were fed on human blood of one blood type followed immediately by a different blood type, they took significantly smaller bloodmeals, their longevity was reduced and they laid fewer eggs per female than control lice that had been fed twice on the same human blood type. When lice were fed human blood that had been stored for 1-26 weeks, the quantity of blood taken, the proportion of lice that became fully engorged and lice longevity diminished gradually as the storage time of the blood increased, but there was no effect of storage time on the mean number of eggs laid per female. However, lice would not feed on 26-week-old blood. The type of anticoagulant used had a significant effect on the proportion fed, longevity and number of eggs laid per female. Generally, EDTA (ethylenediaminetetraacetic acid)-treated blood reduced longevity and the number of eggs laid per female to a greater degree than heparinized or citrated blood. Lice fed on rabbit blood took significantly larger amounts of blood, lived longer and laid a higher mean number of eggs per female than lice fed on human blood. © 2010 The Authors. Medical and Veterinary Entomology © 2010 The Royal Entomological Society.

The impact of HIV-associated anaemia on the incidence of red blood cell transfusion: implications for blood services in HIV-endemic countries.

PubMed

van den Berg, Karin; Murphy, Edward L; Pretorius, Lelanie; Louw, Vernon J

2014-12-01

Cytopaenias, especially anaemia, are common in the HIV-infected population. The causes of HIV related cytopaenias are multi-factorial and often overlapping. In addition, many of the drugs used in the management of HIV-positive individuals are myelosuppresive and can both cause and exacerbate anaemia. Even though blood and blood products are still the cornerstone in the management of severe cytopaenias, how HIV may affect blood utilisation is not well understood. The impact of HIV/AIDS on blood collections has been well documented. As the threat posed by HIV on the safety of the blood supply became clearer, South Africa introduced progressively more stringent donor selection criteria, based on the HIV risk profile of the donor cohort from which the blood collected. The implementation of new testing technology in 2008 which significantly improved the safety of the blood supply enabled the removal of what was perceived by many as a racially based donor risk model. However, this new technology had a significant and sustained impact on the cost of blood and blood products in South Africa. In contrast, it would appear little is known of how HIV influences the utilisation of blood and blood products. Considering the high prevalence of HIV among hospitalised patients and the significant risk for anaemia among this group, there would be an expectation that the transfusion requirements of an HIV-infected patient would be higher than that of an HIV-negative patient. However, very little published data is available on this topic which emphasises the need for further large-scale studies to evaluate the impact of HIV/AIDS on the utilisation of blood and blood products and how the large-scale roll-out of ARV programs may in future play a role in determining the country's blood needs. Copyright © 2014 Elsevier Ltd. All rights reserved.

Estimating the cost of blood: past, present, and future directions.

PubMed

Shander, Aryeh; Hofmann, Axel; Gombotz, Hans; Theusinger, Oliver M; Spahn, Donat R

2007-06-01

Understanding the costs associated with blood products requires sophisticated knowledge about transfusion medicine and is attracting the attention of clinical and administrative healthcare sectors worldwide. To improve outcomes, blood usage must be optimized and expenditures controlled so that resources may be channeled toward other diagnostic, therapeutic, and technological initiatives. Estimating blood costs, however, is a complex undertaking, surpassing simple supply versus demand economics. Shrinking donor availability and application of a precautionary principle to minimize transfusion risks are factors that continue to drive the cost of blood products upward. Recognizing that historical accounting attempts to determine blood costs have varied in scope, perspective, and methodology, new approaches have been initiated to identify all potential cost elements related to blood and blood product administration. Activities are also under way to tie these elements together in a comprehensive and practical model that will be applicable to all single-donor blood products without regard to practice type (e.g., academic, private, multi- or single-center clinic). These initiatives, their rationale, importance, and future directions are described.

[Computer-assisted management of depots for blood products in health establishments].

PubMed

Carré, J

2008-11-01

To manage the filing of blood components at the hospital of the city of Bayeux, the laboratory uses Cursus, a dedicated software for haemovigilance. Benefits for using this software at different steps of the blood bank management are: simplification, security and harmonization of practices during receipt and issurance of blood components, securing recordings with the use of bar codes for patient identification and blood components listing, implementation of a computerized tracking system for transfusion, traceability, limitation of written documents and availability of statistics on the management of the depot.

Preoperative liver dysfunction influences blood product administration and alterations in circulating haemostatic markers following ventricular assist device implantation.

PubMed

Woolley, Joshua R; Kormos, Robert L; Teuteberg, Jeffrey J; Bermudez, Christian A; Bhama, Jay K; Lockard, Kathleen L; Kunz, Nicole M; Wagner, William R

2015-03-01

Preoperative liver dysfunction may influence haemostasis following ventricular assist device (VAD) implantation. The Model for End-stage Liver Disease (MELD) score was assessed as a predictor of bleeding and levels of haemostatic markers in patients with currently utilized VADs. Sixty-three patients (31 HeartMate II, 15 HeartWare, 17 Thoratec paracorporeal ventricular assist device) implanted 2001-11 were analysed for preoperative liver dysfunction (MELD) and blood product administration. Of these patients, 21 had additional blood drawn to measure haemostatic marker levels. Cohorts were defined based on high (≥18.0, n = 7) and low (<18.0, n = 14) preoperative MELD scores. MELD score was positively correlated with postoperative administration of red blood cell (RBC), platelet, plasma and total blood product units (TBPU) , as well as chest tube drainage and cardiopulmonary bypass time. Age and MELD were preoperative predictors of TBPU by multivariate analysis. The high-MELD cohort had higher administration of TBPU, RBC and platelet units and chest tube drainage postimplant. Similarly, patients who experienced at least one bleeding adverse event were more likely to have had a high preoperative MELD. The high-MELD group exhibited different temporal trends in F1 + 2 levels and platelet counts to postoperative day (POD) 55. D-dimer levels in high-MELD patients became elevated versus those for low-MELD patients on POD 55. Preoperative MELD score predicts postoperative bleeding in contemporary VADs. Preoperative liver dysfunction may also alter postoperative subclinical haemostasis through different temporal trends of thrombin generation and platelet counts, as well as protracted fibrinolysis. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Canine and feline blood transfusions: controversies and recent advances in administration practices.

PubMed

Kisielewicz, Caroline; Self, Ian A

2014-05-01

To discuss and review blood transfusion practices in dogs and cats including collection and storage of blood and administration of products. To report new developments, controversial practices, less conventional blood product administration techniques and where applicable, describe the relevance to anaesthetists and anaesthesia. PubMed and Google Scholar using dog, cat, blood transfusion, packed red blood cells and whole blood as keywords. Blood transfusions improve oxygen carrying capacity and the clinical signs of anaemia. However there are numerous potential risks and complications possible with transfusions, which may outweigh their benefits. Storage of blood products has improved considerably over time but whilst extended storage times may improve their availability, a phenomenon known as the storage lesion has been identified which affects erythrocyte viability and survival. Leukoreduction involves removing leukocytes and platelets thereby preventing their release of cytokines and bioactive compounds which also contribute to storage lesions and certain transfusion reactions. Newer transfusion techniques are being explored such as cell salvage in surgical patients and subsequent autologous transfusion. Xenotransfusions, using blood and blood products between different species, provide an alternative to conventional blood products. © 2014 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

Advanced glycation end products and sorbitol in blood from differently compensated diabetic dogs.

PubMed

Comazzi, S; Bertazzolo, W; Bonfanti, U; Spagnolo, V; Sartorelli, P

2008-06-01

Canine diabetes mellitus (DM) is a common metabolic disorder with long term complications, most of which are caused by glycosylation of structural proteins, decreases in antioxidant concentrations, altered osmotic balance and hypoxia due to impaired oxygen transport. Previous studies have demonstrated that under hyperglycemic conditions canine erythrocytes undergo swelling, probably due to activation of the polyol pathway. The present work aimed to assess the plasma concentration of advanced glycation end (AGE) products, stable Amadori-products generated by non-enzymatic glycosylation of proteins and the intracellular concentration of sorbitol, produced by the activation of polyol pathway in 34 blood samples from diabetic dogs and in 14 controls. AGE products were significantly higher (p<0.01) in plasma from diabetic dogs compared with control animals. The sorbitol concentration in erythrocytes was also significantly higher in diabetic dogs and, in particular, in poorly compensated animals and in dogs with ketonuria. In five cases that were analysed before and after clinical improvement, sorbitol concentration was found to correlate with improvement. These results suggest that non-specific glycosylation is increased and that the polyol pathway is activated in diabetic dogs in a manner that is proportionate to the severity of disease. Moreover, the concentration of AGE products and sorbitol may be useful for monitoring the onset of diabetic complications and assessing the most appropriate therapeutic approaches for management of canine DM.

21 CFR 864.9245 - Automated blood cell separator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automated blood cell separator. 864.9245 Section... Blood and Blood Products § 864.9245 Automated blood cell separator. (a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to...

21 CFR 864.9245 - Automated blood cell separator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automated blood cell separator. 864.9245 Section... Blood and Blood Products § 864.9245 Automated blood cell separator. (a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to...

21 CFR 864.9245 - Automated blood cell separator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated blood cell separator. 864.9245 Section... Blood and Blood Products § 864.9245 Automated blood cell separator. (a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to...

21 CFR 864.9245 - Automated blood cell separator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated blood cell separator. 864.9245 Section... Blood and Blood Products § 864.9245 Automated blood cell separator. (a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to...