Clotting factor activity in thawed Octaplas® LG during storage at 2-6°C for 6days from a quality assurance point of view

Transfusion and Apheresis Science

Volumn 46, Issue 2, 2012, Pages 129-136

  Keller, Mareike Kristina ^a   Krebs, Martin ^a   Spies, Claudia ^a   Wernecke, Klaus Dieter ^a   Heger, Andrea ^b   Von Heymann, Christian ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Octapharma GmbH   (Germany)

Author keywords

Clotting factors; Plasma storage; S D plasma

Indexed keywords

BLOOD CLOTTING FACTOR; BLOOD CLOTTING FACTOR 5; BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; FIBRINOGEN; FREE PROTEIN S; OCTAPLAS; PLASMIN INHIBITOR; PROTEIN C; PROTHROMBIN; UNCLASSIFIED DRUG;

ARTICLE; BLOOD CULTURE; BLOOD STORAGE; MICROBIOLOGICAL EXAMINATION; QUALITY CONTROL; TEMPERATURE; THAWING;

BLOOD COAGULATION FACTORS; BLOOD PRESERVATION; HUMANS; PLASMA; QUALITY CONTROL; TIME FACTORS;

EID: 84858289308     PISSN: 14730502     EISSN: 18781683     Source Type: Journal    
DOI: 10.1016/j.transci.2012.01.005     Document Type: Article

References (31)

1. O'Shaughnessy D.F., Atterbury C., Bolton Maggs P., et al. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. British committee for standards in haematology. Blood transfusion task force. Br J Haematol 2004, 126:11-28.
2. Stanworth S.J. The evidence-based use of FFP and cryoprecipitate for abnormalities of coagulation tests and clinical coagulopathy. Hematology Am Soc Hematol Educ Program 2007, 179-186.
3. Goldstein J.N., Rosand J., Schwamm L.H. Wafarin reversal in anticoagulant-associated intracerebral hemorrhage. Neurocrit Care 2008, 9(2):277-283.
4. Ben-Tal O., Zwang E., Eichel R., Badalbev T., Hareuveni M. Vitamin K-dependent coagulation factors and fibrinogen levels in FFP remain stable upon repeated freezing and thawing. Transfusion 2003, 43:873-877.
5. Geeraedts L.M., Demiarl H., Schaap N.P., Kamphuisen P.W., Pompe J.C., Froelke J.P. 'Blind' transfusion of blood products in exsanguinating trauma patients. Resuscitation 2007, 73:382-388.
6. Borgman M.A., Spinella P.C., Perkins J.G., Grathwohl K.W., Repine T., Beekley A.C., et al. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma 2007, 63:805-813.
7. Gonzalez E.A., Moore F.A., Holcomb J.B., Miller C.C., Kozar R.A., Todd S.R., et al. Fresh frozen plasma should be given earlier to patients requiring massive transfusion. J Trauma 2007, 62:112-119.
8. Goldstein J.N., Thomas S.H., Frontiero V., Joseph A., Engel C., Snider R., et al. Timing of fresh frozen plasma administration and rapid correction of coagulopathy in warfarin-related intracerebral hemorrhage. Stroke 2006, 37(1):151-155.
9. Stainsby D., Jones H., Asher D. Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev 2006, 20(4):273. SHOOT Steering Group.
10. Health Protection Agency, press release 17th February 2009. http://www.hpa.org.uk.
11. Llewelyn C.A., Hewitt P.A., Knight R.S. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004, 363:417-421.
12. Wroe S.J., Pal S., Siddique D., Hyare H., Macfarlane R., Joiner S., et al. Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report. Lancet 2006, 368:2061-2067.
13. Health Protection Agency. Fourth case of transfusion-associated variant-CJD infection. Health Protection Report 2007;1(3).
14. Peden A.H., Head M.W., Ritchie D.L., Bell J.E., Ironside J.W. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004, 264:527-529.
15. Dobra S.A., Bennett P.G. VCJD and blood transfusion: risk assessment in the United Kingdom. Transfus Clin Biol 2006, 13:307-311.
16. Gilstad C.W. Anaphylactic transfusion reactions. Curr Opin Hematol 2003, 10:419-423.
17. Flesland O., Seghatchian J., Solheim B.G. The Norwegian plasma fractionation project - A 12-year clinical and economic success story. Transfus Apher Sci 2003, 28:93-100.
18. Sinnott P., Bodger S., Gupta A., Brophy M. Presence of HLA antibodies in single-donor-derived fresh frozen plasma compared with pooled, solvent-detergent treated plasma (Octaplas ®). Eur J Immunogenet 2004, 31:271-274.
19. Heger A., Svae T.E., Neisser-Svae A., Jordan S., Behizad M., Römisch J. Biochemical quality of the pharmaceutically licensed plasma OctaplasLG® after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time. Vox Sang 2009, 97:219-225.
20. Heger A., Roemisch J., Svae T.-E. Stability of solvent/detergent-treated plasma and single-donor fresh-frozen plasma during 48h after thawing. Transfus Apher Sci 2005, 33:257-267.
21. Buchta C., Felfernig M., Höcker P., Macher M., Körmöczi G.F., Quchenberger P., et al. Stability of coagulation factors in thawed, solvent/detergent-treated plasma during storage at 4°C for 6days. Vox Sang 2004, 87:182-186.
22. Paul-Ehrlich-Institut, Bekanntmachung der Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten (Hämotherapie) gemäss §§12 und 18 des Transfusionsgesetzes (TFG) - Änderungen und Ergänzungen 2007 (vom 17. April 2007), Bundesanzeiger 2007;92:5075.
23. Anonymous, Monograph 1646 European Pharmacopoeia. 4th ed. European Directorate for the Quality of Medicines; 2002.
24. Nifong T.P., Light J., Wenk R.E. Coagulant stability and sterility of thawed S/D-treated plasma. Transfusion 2002, 42:1581-1584.
25. von Heymann C., Keller M.K., Spies C., Schuster M., Meinck K., Sander M., et al. Activity of clotting factors in fresh-frozen plasma during storage at 4°C over 6days. Transfusion 2009, 49:913-920.
26. Sidhu R.S., Le T., Brimhall B., Thompson H. Study of coagulation factor activities in apheresed thawed fresh-frozen plasma at 1-6°C for five days. J Clin Apher 2006, 21:224-226.
27. Downes K., Wilson E., Yomtovian R., Sarode R. Serial measurement of clotting factors in thawed plasma stored for 5days (Letter). Transfusion 2001, 41:570.
28. Neisser-Svae A., Bailey A., Gregori L., Heger A., Jordan S., Behizad M., et al. Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG®. Vox Sang 2009, 97:226-233.
29. Keller MK, Pruss A, Spies C, Sander M, Wernecke KD, von Heymann C, Comparison of clotting factor stability in FFP and S/D-treated plasma and stored for 6days at 4°C, Poster 691 SCCM; 2009.
30. de Jonge J., Groenland T.H.N., Metselaar H.J., et al. Fibrinolysis during liver transplantation is enhanced by using solvent/detergent virus-inactivated plasma (ESDEP®). Anesth Analg 2002, 94:1127-1131.
31. US Food and Drug Administration. Guidance for industry. An acceptable circular of information for the use of human blood and blood components; 2003.