DOCSLIB.ORG

Optimizing Whole Blood Storage: Hemostatic Function of 35-Day Stored Product in CPD, CP2D, and CPDA-1 Anticoagulants

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Optimizing Whole Blood Storage: Hemostatic Function of 35-Day Stored Product in CPD, CP2D, and CPDA-1 Anticoagulants ORIGINAL RESEARCH Optimizing whole blood storage: hemostatic function of 35-day stored product in CPD, CP2D, and CPDA-1 anticoagulants Michael Adam Meledeo, PhD , Grantham C. Peltier, MS, Colby S. McIntosh, BS, James A. Bynum, PhD, and Andrew P. Cap, MD, PhD he use of whole blood (WB) for treatment and pre- BACKGROUND: Transitioning from whole blood (WB) to vention of hemorrhagic shock has its roots in the components developed from efforts to maximize donor battlefields of World War I,1 when citrated WB fi yield. Components are advantageous for speci c transfusions proved to be an effective strategy for derangements, but treating hemorrhage with components T 2,3 treatment of the most severely injured combat casualties. requires significantly more volume to provide similar WB use by the military in the early 20th century established effects to WB. Because storage lesion and waste remain the beginnings of the “walking blood bank” concept through problematic, this study examined hemostatic function of refrigerated WB stored for 35 days in anticoagulants widespread usage of fresh whole blood (FWB) collected dur- citrate–phosphate-dextrose-adenosine (CPDA-1), citrate– ing combat. WB use by the military has continued throughout 4 phosphate-dextrose (CPD), or citrate–phosphate-double every major conflict since World War I, but since Vietnam 5 dextrose (CP2D). the use of WB has declined in favor of component therapy. METHODS: Refrigerated WB units from healthy donors The impetus for transitioning to blood component ther- were sampled over 35 days. Global hemostatic apy developed from efforts to maximize the therapeutic yield parameters were measured by thromboelastometry, thrombogram, platelet aggregometry, and platelet adhesion to collagen under shear conditions. The effects ABBREVIATIONS: ASPI = assay for determination of platelet of transfusion filtration and mixing 35-day stored product function triggered by arachidonic acid; CP2D = citrate–phosphate- with fresh WB were evaluated. double dextrose; CPD = citrate–phosphate-dextrose; CPDA-1 = RESULTS: Countable platelets declined as aggregation citrate–phosphate-dextrose-adenosine; CT = clotting time; EXTEM = clusters appeared in microscopy. While gross platelet tissue factor pathway activation thromboelastometry; FFP = fresh agonist-induced aggregation declined over time, frozen plasma; FIBTEM = functional fibrinogen normalization revealed aggregation responses in thromboelastometry; FWB = fresh whole blood; INTEM = contact remaining platelets. Peak thrombin generation increased pathway activation thromboelastometry; MCF = maximum clot over time. Clot strength diminished over storage in tissue firmness; PPP = platelet-poor plasma; PRP = platelet-rich plasma; factor–activated samples (normalized by filtration of ROTEM = rotational thromboelastometry; TRAP = thrombin aggregates). Functional fibrinogen responses remained receptor-activating peptide; WB = whole blood. consistent throughout. Filtration was necessary to maintain consistent platelet adhesion to collagen beyond From the United States Army Institute of Surgical Research, JBSA- collection day. Few differences were observed between Fort Sam Houston, Texas. anticoagulants, and stored/fresh mixing studies Address reprint requests to: Michael Adam Meledeo, PhD, normalized coagulation parameters. United States Army Institute of Surgical Research, 3650 Chambers CONCLUSIONS: WB is easier to collect, store, and Pass, Bldg 3610, JBSA Fort Sam Houston, TX 78234; e-mail: transfuse. WB provides platelets, an oft-neglected, [email protected] critical resuscitation component, but their individual The opinions or assertions contained herein are the private numbers decline as aggregates appear, resulting in views of the authors and not to be construed as official or as reflect- diminished coagulation response. WB has better ing the views of the Department of the Army or the Department of performance in these assays when examined at earlier Defense. time points, but expirations designated to specific Received for publication October 1, 2018; revision received anticoagulants appear arbitrary for hemostatic November 20, 2018, and accepted November 20, 2018. functionality, as little changes beyond 21 days doi:10.1111/trf.15164 regardless of anticoagulant. © 2019 AABB TRANSFUSION 2019;59;1549–1559 Volume 59, April 2019 TRANSFUSION 1549 MELEDEO ET AL. of each blood donor. By separating WB to components, mul- (2–4 C). By 1978, CPD supplemented with adenine (CPDA- tiple patients could benefit; for example, red blood cell (RBC) 1) was in use, increasing the available storage time of WB concentrates could be given for anemia or platelets for and RBCs to 35 days. Extensions in shelf life were attributed thrombocytopenia. These individual components can be to adenine’s contribution to the increased synthesis of aden- stored under different conditions to improve their quality. osine triphosphate.21 Citrate–phosphate-double dextrose Despite a lack of comprehensive clinical trial data comparing (CP2D) has been less commonly used as an anticoagulant for outcomes to WB transfusion, component therapy became the blood and blood products since the 1970s, with the higher most widely used method for all transfusion services, includ- concentration of dextrose and thus higher osmolarity than ing patients with traumatic hemorrhage in both civilian and CPD intended to support RBCs.22 However, CP2D- military settings, as it remains to this day. Strategies have anticoagulated WB has the same 21-day shelf life as CPD. been developed to adapt component transfusion therapy to While CPD is still the primary choice for WB, the the needs of bleeding patients using RBCs, fresh frozen 35-day shelf life of CPDA-1 is appealing for logistical rea- plasma (FFP), and platelets given in a 1:1:1 ratio6 as an alter- sons and waste reduction—albeit with a greater likelihood native to the often unavailable WB product. It has been noted of diminished hemostatic capacity due to developing stor- that this ratio is often difficult to achieve outside of trauma age lesion at later time points. This work examines the centers—platelets, with their short shelf life of 5 days, are fre- hemostatic performance of WB stored at 4 C over 35 days quently unavailable or saved for the most serious cases. in vitro, with a comparison of WB units anticoagulated with However, studies have shown that in some cases treating CPD, CP2D, and CPDA-1. traumatic hemorrhage with blood components leads to a resuscitation milieu requiring a larger volume to achieve the same hemostatic effect when compared to WB.7,8 Recent METHODS studies indicate that this is largely due to the poor aggrega- Collection of FWB tion response of stored, aged platelets, although revised stor- FWB was collected from healthy donors according to an age modalities have been explored to improve platelets’ approved institutional standard operating procedure in functionality (as measured by aggregation and clot forma- * – 450-mL CPD bags (BB AGT456A2, Terumo BCT; n = 7, all tion) over longer durations.9 12 However, all blood compo- male), 450-mL CP2D bags (121–63, Haemonetics; n = 4, all nents suffer from a “storage lesion,” resulting in an overall male), or 500-mL CPDA-1 bags (4R3327E, Fenwal; n = 10, reduced resuscitation capacity and a need to transfuse more 9 male), all with the same expected ratio of anticoagulant to product to achieve desired effects as products age.13 blood (1:7). Units were stored without agitation in a walk-in Platelets play a critical role in maintaining hemostasis refrigerator set to 4 C with constant monitoring. An addi- and have convincingly been shown to contribute to better tional sample of blood was collected in blood collection outcomes and lower mortality when used with other trans- – tubes (K2-EDTA vacutainers, Becton Dickinson) from each fused blood products.14 16 While current US Food and Drug donor for baseline measurements of complete blood Administration blood banking guidelines promote platelet count (CBC). storage at room temperature (resulting in a platelet product with a severely reduced aggregometry response within a few Sample preparation days due to the platelet storage lesion), our group has shown that refrigeration of platelets at 4 C results in preser- On each sampling day (0, 3, 7, 14, 21, 28, and 35), bags were vation of metabolic activity and procoagulant function as gently mixed by hand, and approximately 15 mL of blood observed through improvements in aggregation response, was slowly removed in a sterile environment by Luer lock × clot strength, and adhesion under flow conditions.11,17,18 syringe. Of this, 2 mL was centrifuged at 200 g for Storage of platelets within their WB environment at 4 C 10 minutes to create a platelet-rich plasma (PRP) layer sep- × could combine a more functional platelet product with eas- arated from RBCs, and 2 mL was centrifuged at 2000 g for ier administration, enhanced availability, and increased 20 minutes (twice) to obtain a platelet-poor plasma (PPP). storage capacity, improving the ability to provide hemostatic WB CBC was measured at each time point in an auto- resuscitation in the prehospital setting, during early in- mated hematology analyzer (ABX Micros 60, Horiba). hospital resuscitation, and in austere combat environments. Essential blood chemistry was measured by a blood ana- While component therapy has been the more favored lyzer (i-STAT, CG4+ cartridge; Abbott Laboratories). approach, recent conflicts have renewed interest in WB use on the battlefield.19,20
Load more

Recommended publications
  • 27. Clinical Indications for Cryoprecipitate And
    27. CLINICAL INDICATIONS FOR CRYOPRECIPITATE AND FIBRINOGEN CONCENTRATE Cryoprecipitate is indicated in the treatment of fibrinogen deficiency or dysfibrinogenaemia.1 Fibrinogen concentrate is licenced for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia,2 and is currently funded under the National Blood Agreement. Key messages y Fibrinogen is an essential component of the coagulation system, due to its role in initial platelet aggregation and formation of a stable fibrin clot.3 y The decision to transfuse cryoprecipitate or fibrinogen concentrate to an individual patient should take into account the relative risks and benefits.3 y The routine use of cryoprecipitate or fibrinogen concentrate is not advised in medical or critically ill patients.2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In the setting of major obstetric haemorrhage, early administration of cryoprecipitate or fibrinogen concentrate may be necessary.3 Clinical implications y The routine use of cryoprecipitate or fibrinogen concentrate in medical or critically ill patients with coagulopathy is not advised. The underlying causes of coagulopathy should be identified; where transfusion is considered necessary, the risks and benefits should be considered for each patient. Specialist opinion is advised for the management of disseminated intravascular coagulopathy (MED-PP18, CC-PP7).2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In patients with critical bleeding requiring massive transfusion, suggested doses of blood components is 3-4g (CBMT-PP10)3 in adults or as per the local Massive Transfusion Protocol.
    [Show full text]
  • FDA Regulation of Blood and Blood Components in the United States
    FDA Regulation of Blood and Blood Components in the United States SLIDE 1 This presentation will review the FDA Regulation of Blood and Blood Components in the U.S. SLIDE 2 The FDA Center for Biologics Evaluation and Research, or CBER, Office of Blood Research and Review, called OBRR, reviews several different types of regulatory applications with respect to blood and blood components. This includes biologics license applications, called BLAs, which represent the regulatory pathway for blood components. The BLA regulatory process also applies to biological drugs such as fractionated plasma products. OBRR also regulates in-vitro diagnostic devices used for screening of collected blood, and does so also using the BLA regulatory pathway. Review of these devices as biologic licenses allows CBER to apply a higher level of manufacturing oversight, including lot release testing and pre-licensure inspection. This regulatory pathway applies to infectious disease tests for blood screening, as well as blood grouping and phenotyping reagents. SLIDE 3 The regulatory pathway for New Drug Applications, or NDAs, is most commonly used within the Center for Drug Evaluation and Research, or CDER. Within the Office of Blood, several NDA applications are reviewed each year, mostly involving solutions used for the collection of blood, such as anticoagulants and red cell nutritive solutions. Interestingly, a blood bag that does not have a solution inside is regulated as a device. If the bag has a solution, then it is a drug-device combination product, but is regulated as a drug. SLIDE 4 OBRR reviews both Class Two and Class Three devices. Class Three devices in OBRR include diagnostic tests for HIV regulated as pre-market approvals, called PMAs.
    [Show full text]
  • Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
    Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods Additional copies of this guidance document are available from: Office of Communication, Training and Manufacturers Assistance (HFM-40) 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 (Internet) http://www.fda.gov/cber/guidelines.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) January 2001 Technical Correction February 2001 TABLE OF CONTENTS Note: Page numbering may vary for documents distributed electronically. I. INTRODUCTION ............................................................................................................. 1 II. BACKGROUND................................................................................................................ 1 III. CHANGES FROM THE DRAFT GUIDANCE .............................................................. 2 IV. RECOMMENDED DONOR SELECTION CRITERIA FOR THE AUTOMATED RED BLOOD CELL COLLECTION PROTOCOLS ..................................................... 3 V. RECOMMENDED RED BLOOD CELL PRODUCT QUALITY CONTROL............ 5 VI. REGISTRATION AND LICENSING PROCEDURES FOR THE MANUFACTURE OF RED BLOOD CELLS COLLECTED BY AUTOMATED METHODS.................. 7 VII. ADDITIONAL REQUIREMENTS.................................................................................. 9 i GUIDANCE FOR INDUSTRY Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods This
    [Show full text]
  • Principles of Blood Separation and Apheresis Instrumentation
    Principles of Blood Separation and Apheresis Instrumentation Dobri Kiprov, M.D., H.P. Chief, Division of Immunotherapy, California Pacific Medical Center, San Francisco, CA Medical Director, Apheresis Care Group Apheresis History Apheresis History Apheresis History Apheresis From the Greek - “to take away” Blood separation Donor apheresis Therapeutic apheresis Principles of Blood Separation Filtration Centrifugation Combined centrifugation and filtration Membrane Separation Blood is pumped through a membrane with pores allowing plasma to pass through whilst retaining blood cells. Available as a hollow fiber membrane (older devices used parallel-plate membranes) Pore diameter for plasma separation: 0.2 to 0.6μm. A number of parameters need to be closely controlled Detail of Membrane Separation Courtesy of CaridianBCT Membrane Blood Separation Trans Membrane Pressure (TMP) Too High = Hemolysis TMP Too Low = No Separation Optimal TMP = Good Separation Membrane Apheresis in the US - PrismaFlex (Gambro – Baxter) - NxStage - BBraun Filtration vs. Centrifugation Apheresis Filtration Centrifugation Minimal availability The standard in the in the USA USA • Poor industry support • Very good industry support Limited to plasma Multiple procedures (cytapheresis) exchange • Opportunity to provide • Low efficiency cellular therapies Centrifugation vs. Filtration Apheresis Centrifugation Apheresis Filtration Apheresis Blood Flow 10 – 100 ml/min 150 ml/min Efficiency of Plasma 60 – 65% 30% Removal Apheresis in Clinical Practice and Blood Banking Sickle Cell Disease Falciparum Malaria Thrombocytosis RBC WBC PLT Plasma Leukemias TTP-HUS Cell Therapies Guillain Barre Syndrome Myasthenia Gravis CIDP Autoimmune Renal Disease Hyperviscosity Syndromes Centrifugal Separation Based on the different specific gravity of the blood components. In some instruments, also based on the cellular size (Elutriation).
    [Show full text]
  • Clinical Transfusion Practice
    Clinical Transfusion Practice Guidelines for Medical Interns Foreword Blood transfusion is an important part of day‐to‐day clinical practice. Blood and blood products provide unique and life‐saving therapeutic benefits to patients. However, due to resource constraints, it is not always possible for the blood product to reach the patient at the right time. The major concern from the point of view of both user (recipient) and prescriber (clinician) is for safe, effective and quality blood to be available when required. Standard practices should be in place to include appropriate testing, careful selection of donors, screening of donations, compatibility testing, storage of donations for clinical use, issue of blood units for either routine or emergency use, appropriate use of blood supplied or the return of units not needed after issue, and reports of transfusion reactions – all are major aspects where standard practices need to be implemented. In order to implement guidelines for standard transfusion practices, a coordinated team effort by clinicians, blood transfusion experts, other laboratory personnel and health care providers involved in the transfusion chain, is needed. Orientation of standard practices is vital in addressing these issues to improve the quality of blood transfusion services. Bedside clinicians and medical interns are in the forefront of patient management. They are responsible for completing blood request forms, administering blood, monitoring transfusions and being vigilant for the signs and symptoms of adverse reactions.
    [Show full text]
  • Circular of Information for the Use of Human Blood and Blood Components
    CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD Y AND BLOOD COMPONENTS This Circular was prepared jointly by AABB, the AmericanP Red Cross, America’s Blood Centers, and the Armed Ser- vices Blood Program. The Food and Drug Administration recognizes this Circular of Information as an acceptable extension of container labels. CO OT N O Federal Law prohibits dispensing the blood and blood compo- nents describedD in this circular without a prescription. THIS DOCUMENT IS POSTED AT THE REQUEST OF FDA TO PROVIDE A PUBLIC RECORD OF THE CONTENT IN THE OCTOBER 2017 CIRCULAR OF INFORMATION. THIS DOCUMENT IS INTENDED AS A REFERENCE AND PROVIDES: Y • GENERAL INFORMATION ON WHOLE BLOOD AND BLOOD COMPONENTS • INSTRUCTIONS FOR USE • SIDE EFFECTS AND HAZARDS P THIS DOCUMENT DOES NOT SERVE AS AN EXTENSION OF LABELING REQUIRED BY FDA REGUALTIONS AT 21 CFR 606.122. REFER TO THE CIRCULAR OF INFORMATIONO WEB- PAGE AND THE DECEMBER 2O17 FDA GUIDANCE FOR IMPORTANT INFORMATION ON THE CIRCULAR. C T O N O D Table of Contents Notice to All Users . 1 General Information for Whole Blood and All Blood Components . 1 Donors . 1 Y Testing of Donor Blood . 2 Blood and Component Labeling . 3 Instructions for Use . 4 Side Effects and Hazards for Whole Blood and P All Blood Components . 5 Immunologic Complications, Immediate. 5 Immunologic Complications, Delayed. 7 Nonimmunologic Complications . 8 Fatal Transfusion Reactions. O. 11 Red Blood Cell Components . 11 Overview . 11 Components Available . 19 Plasma Components . 23 Overview . 23 Fresh Frozen Plasma . .C . 23 Plasma Frozen Within 24 Hours After Phlebotomy . 28 Components Available .
    [Show full text]
  • ABO, Rh, HLA Antibodies… Issues with Whole Blood NANCY M
    ABO, Rh, HLA Antibodies… Issues with Whole Blood NANCY M. DUNBAR, MD MEDICAL DIRECTOR, BLOOD BANK DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH, USA The Appeal of Whole Blood WHOLE BLOOD IN EXSANGUINATING PATIENT WHOLE BLOOD OUT Red Cell Compatibility ü Group O is “Universal ABO Group Compatible Donor” for red blood cells Red Cells because the RBCs LACK A Group O and B antigens. O ü Group O people can ONLY Group A A, O receive group O red cells ü Group AB people can Group B B, O receive ANY type. Group AB AB, A, B, O Plasma Compatibility ü Group AB is “Universal ABO Group Compatible Donor” for plasma because Plasma it LACKS anti-A and anti-B Group O antibodies. AB, A, B, O ü Group O people can receive Group A AB, A ANY type of plasma ü Group AB can receive Group B AB, B ONLY AB Group AB AB Practical Teaching Patient COMPATIBLE COMPATIBLE COMPATIBLE ABO Group RED CELLS PLASMA WHOLE BLOOD O O AB, A, B, O O A A, O AB, A A B B, O AB, B B AB AB, A, B, O AB AB Modern Component Therapy GROUP O RBCs and GROUP AB PLASMA IN EXSANGUINATING PATIENT UNKNOWN ABO WHOLE BLOOD OUT PLATELETS Group O Group AB RBCs Plasma ABO ABO Non-Identical ABO Non-Identical Identical RBC and Plasma Compatible Plasma Incompatible IDEAL PREFERRED STRATEGY REALITY IF IDEAL NOT POSSIBLE (SOMETIMES) Transfusion 2013;53:114S-123S • 25 published case reports describing 30 patients with severe hemolytic transfusion reactions following platelet transfusion • Vast majority of cases are group O platelet units transfused to group A or group AB patients Risk Reduction Strategies for Platelet Transfusions 1.
    [Show full text]
  • Abuse of Fresh Frozen Plasma
    BRITISH MEDICAL JOURNAL VOLUME 295 1 AUGUST 1987 287 high in fibre, without excess caffeine containing drinks is hazardous. Blood, or any of its unpasteurised deriva- Br Med J (Clin Res Ed): first published as 10.1136/bmj.295.6593.287 on 1 August 1987. Downloaded from or alcohol, should keep the patient with true functional tives, may transmit infection, including hepatitis and the hypoglycaemia free ofsymptoms. acquired immune deficiency syndrome. Occasionally, the D J BETTERIDGE antibodies present in plasma may produce harmful effects Senior Lecturer in Medicine and Consultant Endocrinologist, for example, leucoagglutinins may cause pulmonary infil- Rayne Institute, trates.8 Anti-A and anti-B in plasma may destroy the University College London, London WC1E 6JJ recipient's red cells, although this hazard can be avoided by using fresh frozen plasma that is ABO compatible. Fresh I Fischer KF, Lees JA, Newman JH. Hypoglycaemia in hospitalized patients, causes and outcome. frozen plasma may also cause hypersensitivity reactions.8 To N EnglJMed 1986;315: 1245-50. 2 Malouf R, Brust JCM. Hypoglycaemia: causes, neurological manifestations and outcome. take a wider view, any fresh plasma retained at a regional Ann Neurol 1985;17:421-30. transfusion centre and supplied as fresh plasma to hospitals is 3 Marks V, Rose FC. Hypoglycaemia. 2nd ed. Oxford: Blackwell Scientific, 1981. 4 Service FJ. Hypoglycaemic disorders. Boston: G K Hall, 1983. withheld from the national Blood Products Laboratory. In 5 Nelson RL. Hypoglycaemia-fact or fiction. Mayo Clin Proc 1985;60:844-50. is now called 6 Plum F. What causes infarction in ischaemic brain? The Robert Wartenberg lecture.
    [Show full text]
  • Side Effects of Blood Donation by Apheresis Adverse Events Donor
    Adverse events Side effects of blood donation by apheresis Adverse events of “blood collections” • Whole blood collections Hans Vrielink, MD, PhD • Apheresis collections Department of Transfusion Medicine • Donors • Adverse events c an be local and / or systemic or both • Events must be registered 2 Donor side effects after WB-donation Donor complications after WB-donation 1000 random donors interview ed 3 w eeks post donation (WB; 500 mL) Adverse Events Incidence % • 36% donors had one or more A E • Female : men = 2:1 (48 vs 23%) Local / Systemic • FD > RD (47 vs 36%) Bruis e / Hematoma 25 • Race affects bruising • Spontaneous reported < solic ited rates Arm pain 10 • Rates differ w ith interview er and used questions Burning Numbness Tingling 1 Fatigue 8 Vasovagal sy mptoms 5 Nausea vomiting 1 3 4 Newman B, et al. Transfusion 2003 Newman B, et al. Transfusion 2003 Effect Adverse Events on Return Rates (RR) Effect Adverse Events on Return Rates (RR) 1000 interview ed random WB-donors number return v isits (follow -up 9-21 Adverse Events % decrease months) Hematoma (inc idence 15%) 0 (n.s.) Estimated overall effect various A E on s ubsequent donation in general Pain in arm (7%) 2 (n.s.) blood donor population = 6% reduction Fatigue (5%) 20 •Greatest impact Vas ovagal sy mptoms Donor reaction (4%) 34 •Combinations: synergistic reducing effect (pain + fatigue: 65 instead 22) Donor reaction + pain arm 35 Pain arm + fatigue 65 Donor reaction + fatigue 66 Donor reaction + fatigue + pain arm 85 Estimated RR without AE: 1.32 visits / yr 5 6 Newman B, et al.
    [Show full text]
  • Guidance for Industry
    Guidance for Industry “Computer Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type) Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, or by calling 1-800-835-4709 or 301-827-1800, or email [email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or e-mail address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research April 2011 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 III. TERMS USED IN THIS GUIDANCE............................................................................ 3 IV. ELEMENTS OF A COMPUTER CROSSMATCH SYSTEM .................................... 5 A. Data Entry Review and Acceptance.................................................................... 5 B. Recipient Data Elements ...................................................................................... 5 C. Donor Data Elements...........................................................................................
    [Show full text]
  • Guidelines for Cryoprecipitate Transfusion
    Nadejda Droubatchevskaia, MD, Michelle P. Wong, MD, Kate M. Chipperfield, MD, FRCPC, Louis D. Wadsworth, MB, ChB, FRCPC, FRCPath, David J. Ferguson, MD, FRCPC Guidelines for cryoprecipitate transfusion A new document from the Transfusion Medicine Advisory Group describes appropriate use of cryoprecipitate plasma. ABSTRACT: The literature shows he Transfusion Medicine Ad - tologists and critical care physicians, there is often inappropriate use visory Group (TMAG) of BC and were subsequently approved by the of blood products, including cryo - T has prepared guidelines to pro- Transfusion Medicine Advisory Group precipitate plasma, because of in - vide physicians with current informa- (see Appendix B). adequate education of physicians. tion on the appropriate use of cryopre- Guidelines for cryoprecipitate trans- General considerations cipitate plasma. These guidelines are fusion have been developed by the available electronically on the British Physicians contemplating the use of Transfusion Medicine Advisory Group Table Columbia Provincial Coordinating cryoprecipitate (see ), should of British Columbia to educate clini- Office web site (www.blood keep in mind the following general cians and address transfusion prac- link.bc.ca) and will be updated period- considerations: tices in the province. These guide- ically. Prescribing physicians are • In British Columbia, informed con- lines are based on a MEDLINE responsible for referring to the most sent is required for the transfusion of search and consultation with hema- recent guidelines. cryoprecipitate. to pathologists and clinicians. At pre- • All routine coagulation parameters sent, transfusion of cryoprecipitate How the guidelines is indicated for hypofibrinogen emia/ were developed Dr Droubatchevskaia is a hema topatholo - dysfibrinogenemia, von Willebrand gist at St. Paul’s Hospital in Vancouver, These guidelines were developed to disease, hemophilia A, factor XIII British Columbia.
    [Show full text]
  • Guidelines for the Transfusion of Packed Red Blood Cells, Fresh Frozen
    MANUAL: POLICY #: SUBJECT: Guidelines for the transfusion of EFFECTIVE DATE: packed red blood cells, fresh frozen REVISED DATE: plasma, platelets, and cryoprecipitate in critically ill AUTHORIZED patients APPROVAL: PERSONNEL Nursing, respiratory and physician COVERED: care providers of relevant patients in intensive care unit environments PAGE: 1 OF 4 PURPOSE The purpose of this policy is to develop a clinical practice guideline for the transfusion of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate in adult patients in (surgical) intensive care unit environments. Blood products are a scarce resource and their transfusion may result in complications, suggesting that an evidence-based approach for practice, tailored to clinical situations, is most appropriate. DEFINITION Packed red blood cells are used to treat hemorrhage and anemia as well as to improve oxygen delivery to tissues. Fresh frozen plasma is a blood component from whole blood or collected by apheresis, frozen within time limits and at a temperature such as to preserve the labile clotting factors adequately. It is dosed at 10- 15mL/kg of body weight, depending on clinical situation in an ABO- (not necessarily Rh-) compatible fashion. Platelets are a blood component from whole blood or collected by apheresis transfused in an ABO- and Rh-compatible fashion in those with thrombocytopenia (<100,000), relative thrombocytopenia depending on circumstance (<10-100,000) or thrombocytopathia. Cryoprecipitate is a blood component containing fibrinogen and other coagulation factors (e.g. Factor 8, 13 and von Willebrand’s factor). POLICY Transfusions of packed red blood cells, fresh frozen plasma, platelets and/or cryoprecipitate will be ordered by ICU care providers in consultation with the primary team and relevant consultants.
    [Show full text]