The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh-frozen plasma prepared within eight hours of collection

Transfusion

Volumn 55, Issue 3, 2015, Pages 476-484

  Dumont, Larry J ^a   Cancelas, Jose A ^b   Maes, Lou Ann ^c   Rugg, Neeta ^b   Whitley, Pamela ^c   Herschel, Louise ^a   Siegel, Alan H ^a   Szczepiorkowski, Zbigniew M ^a   Hess, John R ^d   Zia, Majid ^e  

^a DARTMOUTH MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c AMERICAN RED CROSS   (United States)

^d UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^e The Food System Institute   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTITHROMBIN; BLOOD CLOTTING FACTOR; COMPLEMENT COMPONENT C3A; COMPLEMENT COMPONENT C3A [DEARGININE]; COMPLEMENT COMPONENT C5; COMPLEMENT COMPONENT C5A; COMPLEMENT COMPONENT C5A [DEARGININE]; FIBRINOPEPTIDE A; FRESH FROZEN PLASMA; HEMOGLOBIN; PLASMA PROTEIN; PRESERVATIVE; PROTHROMBIN; THROMBIN ANTITHROMBIN COMPLEX; UNCLASSIFIED DRUG; VON WILLEBRAND FACTOR CLEAVING PROTEINASE; ANTICOAGULANT AGENT; CITRATE PHOSPHATE DEXTROSE; CITRIC ACID; GLUCOSE; SOLUTION AND SOLUBILITY;

ANTICOAGULATION; ARTICLE; BIOEQUIVALENCE; BLOOD COLLECTION TUBE; BLOOD FILTER; BLOOD FILTRATION; BLOOD STORAGE; COMPARATIVE STUDY; CONTROLLED STUDY; EVALUATION STUDY; HEMATOLOGY ANALYZER; HUMAN; INTERNATIONAL NORMALIZED RATIO; MULTICENTER STUDY; PARTIAL THROMBOPLASTIN TIME; PROTEIN DEGRADATION; PROTEIN DETERMINATION; PROTHROMBIN TIME; ROOM TEMPERATURE; STORAGE TEMPERATURE; TIME; TRANSFUSION; BLOOD CLOTTING TEST; CHEMISTRY; CLINICAL TRIAL; CRYOPRESERVATION; IN VITRO STUDY; LEUKAPHERESIS; PHARMACOLOGY; PLASMA; PROCEDURES; SOLUTION AND SOLUBILITY; TEMPERATURE; THERAPEUTIC EQUIVALENCE;

ANTICOAGULANTS; BLOOD COAGULATION FACTORS; BLOOD COAGULATION TESTS; BLOOD PRESERVATION; BLOOD PROTEINS; CITRATES; CRYOPRESERVATION; GLUCOSE; HUMANS; IN VITRO TECHNIQUES; LEUKOCYTE REDUCTION PROCEDURES; PHARMACEUTICAL SOLUTIONS; PLASMA; TEMPERATURE; THERAPEUTIC EQUIVALENCY; TIME FACTORS;

EID: 84924379419     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.12864     Document Type: Article

References (20)

1. Pietersz RN,. Storage of whole blood for up to 24 hours at ambient temperature before component preparation: implementation in the Netherlands. Transfusion 2011; 51: 3S-6S.
2. Hess JR,. An update on solutions for red cell storage. Vox Sang 2006; 91: 13-19.
3. Hess JR, Rugg N, Joines AD, et-al. Buffering and dilution in red blood cell storage. Transfusion 2006; 46: 50-54.
4. Keitel S,. The guide to the preparation, use and quality assurance of blood components. Part D Plasma Components. 17th ed. Strasbourg: Directorate for the Quality of Medicines & HealthCare of the Council of Europe; 2013. pp. 351-367.
5. Statistical Approaches to Establishing Bioequivalence. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). January 2001 [cited 2013 Nov 29]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070244.pdf
6. Lee L, Morfini M, Schulman S, et-al.; the Factor VIII/Factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Haemostasis. The design and analysis of pharmacokinetic studies of coagulation factors. 2001 [cited 2014 Jul 21]. Available from: http://c.ymcdn.com/sites/www.isth.org/resource/group/d4a6f49a-f4ec-450f-9e0f-7be9f0c2ab2e/official-communications/fviiipharmaco.pdf
7. Cancelas JA, Dumont LJ, Maes LY, et-al. Additive solution-7 (AS-7) reduces the red blood cell cold-storage lesion. Transfusion 2014. doi: 10.1111/trf.12867.
8. Dumont LJ, Cancelas JA, Maes LY, et-al. Overnight, room-temperature hold of whole blood followed by 42-day storage of RBCs in additive solution-7. Transfusion 2014. doi: 10.1111/trf.12868.
9. An Acceptable Circular of Information for the Use of Human Blood and Blood Components. pp. 20-30. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. August 2013 [cited 2013 Dec 23]. Available from: http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm364565.htm
10. Lu Y, Chow SC, Zhu S,. In vivo and in vitro bioequivalence testing. J Bioequiv Availab 2014; 6: 67-74.
11. Cardigan R, Van der Meer PF, Pergande C, et-al. Coagulation factor content of plasma produced from whole blood stored for 24 hours at ambient temperature: results from an international multicenter BEST Collaborative study. Transfusion 2011; 51: 50S-57S.
12. Thomas S,. Ambient overnight hold of whole blood prior to the manufacture of blood components. Transfus Med 2010; 20: 361-368.
13. Shinar E, Etlin S, Frenkel O, et-al. The implementation of rapid cooling and overnight hold of whole blood at ambient temperature before processing into components in Israel. Transfusion 2011; 51: 58S-64S.
14. Hubbard AR,. International biological standards for coagulation factors and inhibitors. Semin Thromb Hemost 2007; 33: 283-289.
15. Evaluation of Potential New Plasma Products Manufactured Following Storage at Room Temperature for up to 24 Hours. May 16, 2012 [cited 2013 Nov 29]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm298652.htm
16. Alhumaidan H, Cheves T, Holme S, et-al. Stability of coagulation factors in plasma prepared after a 24-hour room temperature hold. Transfusion 2010; 50: 1934-1942.
17. Naghadeh HT, Maghsudloo M, Tabatabaei MR,. Coagulation factors V, VIII, and X, prothrombin time and activated partial thromboplastin time test results in thawed plasma stored at 1-6 °C for 5 days. Blood Transfus 2011; 9: 95-98.
18. Sheffield WP, Bhakta V, Mastronardi C, et-al. Changes in coagulation factor activity and content of di(2-ethylhexyl)phthalate in frozen plasma units during refrigerated storage for up to five days after thawing. Transfusion 2012; 52: 493-502.
19. Tholpady A, Monson J, Radovancevic R, et-al. Analysis of prolonged storage on coagulation Factor (F)V, FVII, and FVIII in thawed plasma: is it time to extend the expiration date beyond 5 days? Transfusion 2013; 53: 645-650.
20. Wang Z, Du X, Li C, et-al. Coagulation factors and inhibitors in thawed plasma stored at 1-6 °C for 5 days in China. Transfus Apher Sci 2014; 50: 274-280.