Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: Transfusion of patients with congenital coagulation factor deficiencies

Transfusion

Volumn 45, Issue 8, 2005, Pages 1362-1372

  De Alarcon, Pedro ^b   Benjamin, Richard ^b   Dugdale, Marion ^b   Kessler, Craig ^b   Shopnick, Rinah ^b   Smith, Peter ^b   Abshire, Thomas ^b   Hambleton, Julie ^b   Matthew, Prasad ^b   Ortiz, Idith ^b   Cohen, Alice ^b   Konkle, Barbara A ^b   Streiff, Michael ^b   Lee, Martin ^b   Wages, David ^b   Corash, Laurence ^a  

^a CERUS CORPORATION   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMOTOSALEN; AMOTOSALEN HCL; BLOOD CLOTTING FACTOR 10; BLOOD CLOTTING FACTOR 11; BLOOD CLOTTING FACTOR 13; BLOOD CLOTTING FACTOR 5; BLOOD CLOTTING FACTOR 7; FIBRINOGEN; FRESH FROZEN PLASMA; PROTEIN C; PROTHROMBIN; PSORALEN; UNCLASSIFIED DRUG; BLOOD CLOTTING FACTOR; PSORALEN DERIVATIVE; S 59, PSORALEN; S-59, PSORALEN;

ADOLESCENT; ADULT; AGED; ALLERGY; ARTICLE; BLOOD CLOTTING DISORDER; BLOOD TRANSFUSION REACTION; BRONCHOSPASM; CHILD; CHILL; CONGENITAL DISORDER; CONSTIPATION; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMOGLOBINURIA; HEMOLYSIS; HEMOSTASIS; HUMAN; KINETICS; MALE; NAUSEA; PARTIAL THROMBOPLASTIN TIME; PLASMA TRANSFUSION; PROTHROMBIN TIME; RASH; URTICARIA; VOMITING; BLOOD; BLOOD STORAGE; BLOOD TRANSFUSION; CLINICAL TRIAL; INFANT; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PLASMA; PRESCHOOL CHILD;

ADOLESCENT; ADULT; AGED; BLOOD COAGULATION DISORDERS; BLOOD COAGULATION FACTORS; BLOOD PRESERVATION; BLOOD TRANSFUSION; CHILD; CHILD, PRESCHOOL; FEMALE; HEMOSTASIS; HUMANS; INFANT; MALE; MIDDLE AGED; PLASMA; PROTHROMBIN TIME; PSORALENS;

EID: 23844453081     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2005.00216.x     Document Type: Article

References (47)

1. Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002;42:975-9.
2. Schuttler GC, Caspari C, Jursch CA, et al. Hepatitis C virus transmission by a blood donation negative in nucleic acid amplification tests for viral RNA. Lancet 2000;355:41-2.
3. Biggerstaff BJ, Petersen LR. Estimated risk of transmission of the West Nile virus through blood transfusion in the US, 2002. Transfusion 2003;43:1007-17.
4. Horowitz B, Bonomo R, Prince AM, et al. Solvent/detergent treated plasma: a virus-inactivated substitute for fresh frozen plasma. Blood 1992;79:826-31.
5. Mohr H, Lambrecht B, Schmidt H. Manufacturing and characteristics of methylene blue/light treated human plasma. Photochem Photobiol 1993;57(Suppl):68S.
6. Alfonso R, Lin C, Dupuis K, et al. Inactivation of viruses with preservation of coagulation function in fresh frozen plasma. Blood 1996;88(Suppl 1):526a.
7. Lin L, Cook DN, Wiesehahn GP, et al. Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long-wavelength ultraviolet light. Transfusion 1997;37:423-35.
8. Corash L. Virus "safe" products/pathogen reduction. In: Hillyer CD, Silberstein LE, Ness PM, Anderson KC, Roush KS, editors. Blood banking and transfusion medicine. Philadelphia: Churchill livingstone; 2003. p. 241-51.
9. Hambleton J, Wages D, Radu-Radulescu L, et al. Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin. Transfusion 2002;42:1302-7.
10. vanRhenen D, Gulliksson H, Cazenave JP, et al. Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial. Blood 2003;101:2426-33.
11. Development Task Force of the College of American Pathologists. Practice parameters for the use of fresh-frozen plasma, cryoprecipitate, and platelets. JAMA 1994;271:777-81.
12. Ciaravino V, McCullough T, Cimino G, Sullivan T. Preclinical safety profile of plasma prepared using the INTERCEPT blood system. Vox Sang 2003;85:171-82.
13. Ciaravino V, McCullough T, Cimino G. The role of toxicology assessment in transfusion medicine. Transfusion 2003; 43:1481-92.
14. Ciaravino V, McCullough T, Sullivan T, Bebee L. 26-week IV oncogenicity study with S-59 photochemically treated (PCT) 35% plasma [before and after illumination with and without S-59 reduction device (SRD) treatment] in C57BL/6T -KOp53, N5 (+/-) mice. Toxicologist 2001;60(Suppl 1):279.
15. Ciaravino V. Preclinical safety of a nucleic acid-targeted helinx compound: a clinical perspective. Semin Hematol 2001;38(Suppl 11):12-9.
16. Lee M, Morfini S, Schulman S, Ingerslev J. Scientific and Standardization Committee communication: the design and analysis of pharmacokinetic studies of coagulation factors [Internet]. Chapel Hill (NC): International Society for Thrombosis and Haemostasis; 2001. Available from: http:// www.med.unc.edu/isth/ SSC/communications/ factor8and9/fviiipharmaco.pdf
17. Morfini M, Lee M, Messori A. The design and analysis of half-life and recovery studies for factor VIII and factor IX. Thromb Haemost 1991;66:384-6.
18. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;2:109-17.
19. Lee ML, Poon WY, Kingdon HS. A two-phase linear regression model for biologic half-life data. J Lab Clin Med 1990;115:754-8.
20. Gmur J, Burger J, Schanz U, Fehr J, Schaffner A. Safety of a stringent prophylactic platelet transfusion policy for patients with acute leukemia. Lancet 1991;338:1223-6.
21. Shusterman S, Manno CS. Transfusion of the patient with congenital coagulation defects. In: Hillyer CD, Silberstein LE, Ness PM, et al. editors. Blood banking and transfusion medicine. Philadelphia: Churchill Livingstone; 2003. p. 291-306.
22. Snyder E. Transfusion reactions. In: Hoffman R, Benz E, editors. Hematology: basic principles and practice. Philadelphia: Churchill Livingstone; 2000.
23. Alving B. Transfusion of the patient with acquired coagulation defects. In: Hillyer CD, Silberstein LE, Ness PM, Anderson KC, Roush KS, editors. Blood banking and transfusion medicine. Philadelphia: Churchill Livingstone 2003; p. 307-20.
24. Rodgers GM, Greenberg CS. Inherited coagulation disorders. In: Lee GR Foerster J, Lukens J, et al. editors. Wintrobe's clinical hematology. Vol. 2, 10th ed. Philadelphia: Lippincott Williams & Wilkins; 1999. p. 1682-732.
25. Mannucci PM, Federici AB, Sirchia G. Hemostasis testing during massive blood replacement. Vox Sang 1982;42:113-23.
26. Peyvandi F, Mannucci PM. Rare coagulation disorders. Thromb Haemost 1999;82:1207-14.
27. Menitove JE, Gill JC, Montgomery R. Preparation and clinical use of plasma and plasma fractions. In: Beutler E, Lichtman MA, Coller BS, Kipps TJ, editors. Williams hematology. 5th ed. New York: McGraw-Hill; 1995. p. 1649-63.
28. Greenberg CS, Orthner CL. Blood coagulation and fibrinolysis. In: Foerster J, Lukens J, Paraskevas F, Greer JP, Rodgers GM, editors. Wintrobe's clinical hematology. Vol. 1, 10th ed. Baltimore: Lippincott Williams & Wilkins; 1999. p. 685-764.
29. Goodnight SH, Hathaway WE. Plasma. Disorders of hemostasis and thrombosis. New York: McGraw-Hill; 2001. p. 497.
30. MacKenzie M, Hambleton J, Adams M, et al. The kinetics of proteins C and S activity are retained in INTERCEPT plasma (IFFP). Transfus Clin Biol 2001;8(Suppl 1):102s.
31. Lee ML, Gomperts ED, Kingdon HS. A note on the calculation of recovery for Factor VIII infusions. Thromb Haemost 1993;69:87.
32. Lindley CM, Sawyer WT, Macik G, et al. Pharmacokinetics and pharmacodynamics of recombinant factor VIIa. Clin Pharmacol Ther 1994;55:638-48.
33. Mintz PD, Avery NL, Moulaison SL, Flanagan HL, Boyd JC. Preparation of cryoprecipitate from photochemically treated fresh frozen plasma. Transfusion 2000;40(Suppl 1):63S.
34. Mintz P, Steadman R, Blackall D, et al. Pathogen inactivated fresh frozen plasma prepared using Helinx™ technology is efficacious and well tolerated in treatment of end-stage liver disease patients-the STEP AC trial. Blood 2001;98(Suppl 1):709a.
35. Lambrecht B, Mohr H, Knuver-Hopf J, Schmitt H. Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang 1991;60:207-13.
36. Roberts P. Resistance of vaccinia virus to inactivation by solvent/detergent treatment of blood products. Biologicals 2000;28:29-32.
37. Mast AE, Stadanlick JE, Lockett JM, Dietzen DJ. Solvent/ detergent-treated plasma has decreased antitrypsin activity and absent antiplasmin activity. Blood 1999;94:3922-7.
38. Yarranton H, Cohen H, Pavord SR, et al. Venous thromboembolism associated with management of acute thrombotic thrombocytopenic purpura. Br J Haematol 2003;121:778-85.
39. Garwood M, Cardigan RA, Drummond O, et al. The effect of methylene blue photoinactivation and methylene blue removal on the quality of fresh-frozen plasma. Transfusion 2003;43:1238-47.
40. Zucker-Franklin D, Cao Y. Megakaryocytes of human immunodeficiency virus-infected individuals express viral RNA. Proc Natl Acad Sci U S A 1989;86:5595.
41. Atance R, Pereira A, Ramirez B. Transfusing methylene blue-photoinactivated plasma instead of FFP is associated with an increased demand for plasma and cryoprecipitate. Transfusion 2001;41:1548-52.
42. 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;43:873-7.
43. Burnouf T, Kappelsberger C, Frank K, Burkhardt T. Protein composition and activation markers in plasma collected by three apheresis procedures. Transfusion 2003;43:1223-9.
44. Grass JA, Hei DJ, Metchette K, et al. Inactivation of leukocytes in platelet concentrates by psoralen plus UVA. Blood 1998;91:2180-8.
45. Yarranton H, Lawrie AS, Mackie IJ, et al. Coagulation factor levels in cryosupernatant treated with amotosalen HCl (S-59) and UVA light-a suitable plasma replacement in thrombotic thrombocytopenic purpura. Blood 2003;102: 817a.
46. Mintz PD, Neff A, MacKenzie M, et al. Therapeutic plasma exchange (TPE) for thrombotic thrombocytopenic purpura (TTP) using plasma prepared with photochemical treatment (INTERCEPT plasma). Blood 2004;104:239a.
47. Beeck H, Hellstern O. In vitro characterization of solvent/detergent- treated human plasma and quarantine fresh frozen plasma. Vox Sang 1998;74(Suppl 1):219-23.