A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura

Transfusion

Volumn 46, Issue 10, 2006, Pages 1693-1704

  Mintz, Paul D ^b   Neff, Anne ^b   MacKenzie, Malcolm ^b   Goodnough, Lawrence T ^b   Hillyer, Christopher ^b   Kessler, Craig ^b   McCrae, Keith ^b   Menitove, Jay E ^b   Skikne, Barry S ^b   Damon, Lloyd ^b   Lopez Plaza, Ileana ^b   Rouault, Charles ^b   Crookston, Kendall P ^b   Benjamin, Richard J ^b   George, James ^b   Lin, Jin Sying ^b   Corash, Laurence ^a   Conlan, Maureen G ^b  

^a CERUS CORPORATION   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMOTOSALEN; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR; FRESH FROZEN PLASMA; GLUCOCORTICOID; PREDNISONE; VON WILLEBRAND FACTOR CLEAVING PROTEINASE;

ADULT; AGED; ANGINA PECTORIS; ARTICLE; BLOOD TRANSFUSION REACTION; BRADYCARDIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; GENERAL CONDITION IMPROVEMENT; HEART ARREST; HUMAN; MALE; OUTCOME ASSESSMENT; PHOTOCHEMISTRY; PLASMAPHERESIS; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; SAFETY; SINUS ARRHYTHMIA; TACHYCARDIA; THROMBOCYTE COUNT; THROMBOTIC THROMBOCYTOPENIC PURPURA; ULTRAVIOLET A RADIATION; URTICARIA;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD COAGULATION FACTORS; CHILD; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFECTION CONTROL; MALE; MIDDLE AGED; PLASMA EXCHANGE; PSORALENS; PURPURA, THROMBOTIC THROMBOCYTOPENIC; RECURRENCE; REMISSION INDUCTION; TIME FACTORS; ULTRAVIOLET RAYS;

EID: 33748950122     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2006.00959.x     Document Type: Article

References (48)

1. Amorosi EL, Ultmann JE. Thrombotic thrombocytopenic purpura: report of 16 cases and review of the literature. Medicine 1966;45:139-59.
2. Bell WR, Braine HG, Ness PM, Kickler TS. Improved survival in thrombotic thrombocytopenic purpura-hemolytic uremic syndrome. N Engl J Med 1991;325:398-403.
3. Bandarenko N, Brecher ME. United States Thrombotic Thrombocytopenic Purpura Apheresis Study Group (USTTP ASG): multicenter survey and retrospective analysis of current efficacy of therapeutic plasma exchange. J Clin Apher 1998;13:133-41.
4. Rock G, Shumak KH, Buskard NA, et al. Comparison of plasma exchange with plasma infusion in the treatment of thrombotic thrombocytopenic purpura. N Engl J Med 1991;325:393-7.
5. Furlan M, Robles R, Galbusera M, et al. von Willebrand factor-cleaving protease in thrombotic thrombocytopenic purpura and the hemolytic-uremic syndrome. N Engl J Med 1998;339:1578-84.
6. Tsai H, Lian EC. Antibodies to von Willebrand factor-cleaving protease in acute thrombotic thrombocytopenic purpura. N Engl J Med 1998;339:1585-94.
7. Rizvi MA, Vesely SK, George JN, et al. Complications of plasma exchange in 71 consecutive patients treated for clinically suspected thrombotic thrombocytopenic purpura-hemolytic uremic syndrome. Transfusion 2000;40:896-901.
8. George JN, Vesely SK, Terrell DR. The Oklahoma Thrombotic Thrombocytopenic Purpura-Hemolytic Uremic Syndrome (TTP-HUS) Registry: a community perspective of patients with clinically diagnosed TTP-HUS. Semin Hematol 2004;41:60-7.
9. Busch MP, Young MJ, Samson SM, et al. Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group. Transfusion 1991;31:4-11.
10. 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.
11. Busch M, Kleinman S, Nemo G. Current and emerging risks of blood transfusion. JAMA 2003;289:952-62.
12. Busch MP, Caglioti S, Robertson EF, et al. Screening the blood supply for West Nile virus RNA by nucleic acid amplification testing. N Engl J Med 2005;353:460-7.
13. Petersen LR, Epstein JS. Problem solved? West Nile virus and transfusion safety. N Engl J Med 2005;353:516-7.
14. Stramer SL, Fang CT, Foster GA, et al. West Nile virus among blood donors in the United States, 2003 and 2004. N Engl J Med 2005;353:451-9.
15. Sawyer L, Mababangloob R, Sampson-Johannes A, et al. Inactivation of blood-borne pathogens in apheresis plasma using the INTERCEPT Blood System [abstract]. Transfusion 2004;44:103A.
16. Donnelly B, Mababangloob R, Kinsey J, Probst M, Sawyer L. INTERCEPT Blood System inactivates pathogens over a range of processing conditions [abstract]. Transfusion 2004;44:103A.
17. Jauvin V, Alfonso RD, Guillemain B, Dupuis K, Fleury HJ. In vitro photochemical inactivation of cell-associated human T-cell leukemia virus Type I and II in human platelet concentrates and plasma by use of amotosalen. Transfusion 2005;45:1151-9.
18. de Alarcon P, Benjamin R, Dugdale M, et al. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies. Transfusion 2005;45:1362-72.
19. Mackie I, Yarranton H, Machin S, Pinkowski L, Corash L. von Willebrand factor cleaving protease activity is retained in INTERCEPT plasma [abstract]. Transfusion 2004;44:102a.
20. Yarranton H, Lawrie AS, Mackie IJ, et al. Coagulation factor levels in cryosupernatant prepared from plasma treated with amotosalen hydrochloride (S-59) and ultraviolet A light. Transfusion 2005;45:1453-8.
21. Mintz PD, Avery NL, Moulaison SL, et al. Preparation of cryoprecipitate from photochemically treated fresh frozen plasma [abstract]. Transfusion 2000;40(10S):63S.
22. Hambleton J, Wages D, Radu-Radulescu Adams M, 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.
23. Mintz P, Bass N, Petz L, et al. Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease. Blood 2006;107:3753-60.
24. MedDRA introductory guide. Version 3.3. Reston (VA): MedDRA MSSP; 2002.
25. Gerritsen HE, Turecek PL, Schwarz HP, Lammle B. Assay of von Willebrand factor (VWF)-cleaving protease based on decreased collagen binding affinity of degraded VWF: a tool for the diagnosis of thrombotic thrombocytopenic purpura (TTP). Thromb Haemost 1999;82:1386-9.
26. Lin L, Conlan MG, Tessman J, Cimino G, Porter S. Amotosalen interactions with platelet and plasma components: absence of neoantigen formation after photochemical treatment. Transfusion 2005;45:1610-20.
27. Standards for blood banks and transfusion services. 22nd ed., Standard 5.4. Bethesda: American Association of Blood Banks; 2003. p. 19-21.
28. Standards for blood banks and transfusion services. 22nd ed., Standard 5.5. Bethesda: American Association of Blood Banks; 2003. p. 21-22.
29. Standards for blood banks and transfusion services. 22nd ed., Standard 5.8. Bethesda: American Association of Blood Banks; 2003. p. 37.
30. Moake JL, Chintagumpala M, Turner N, et al. Solvent/detergent-treated plasma suppresses shear-induced platelet aggregation and prevents episodes of thrombotic thrombocytopenic purpura. Blood 1994;84:490-7.
31. Rock G, Shumak K, Sutton DM, et al. Cryosupernatant as replacement fluid for plasma exchange in thrombotic thrombocytopenic purpura. Br J Haematol 1996;94:383-6.
32. Rock G, Anderson D, Clark W, et al. Does cryposupernatant plasma improve outcome in thrombotic thrombocytopenic purpura? No answer yet. Br J Haematol 2005;129:79-86.
33. Zeigler ZR, Shadduck RK, Gryn JF, et al. Cryoprecipitate poor plasma does not improve early response in primary adult thrombotic thrombocytopenic purpura (TTP). J Clin Apher 2001;16:19-22.
34. Hellstern P, Hannelore H. Manufacture and composition of fresh frozen plasma and virus-inactivated therapeutic plasma preparations: correlation between composition and therapeutic efficacy. Thromb Res 2002;107:S3-8.
35. Horowitz MS, Pehta JC. SD plasma in TTP and coagulation factor deficiencies for which no concentrates are available. Vox Sang 1998;74:231-5.
36. Zheng XL, Kaufman RM, Goodnough LT, Sadler JE. Effect of plasma exchange on plasma ADAMTS13 metalloprotease activity, inhibitor level, and clinical outcome in patients with idiopathic and non-idiopathic thrombotic thrombocytopenic purpura. Blood 2004;103:4043-9.
37. Fakhouri F, Vernant JP, Veyradier A, et al. Efficiency of curative and prophylactic treatment with rituximab in ADAMTS13 deficient-thrombotic thrombocytopenic purpura: a study of 11 cases. Blood 2005;106:1932-7.
38. Rock G, Moeslichan MZ, Benny B, et al. Solvent detergent treated plasma: an alternative to cryosupernatant plasma in thrombotic thrombocytopenic purpura [abstract]. Vox Sang 2005;89(S2):11.
39. Evans G, Llewelyn C, Luddington R, Baglin TP, Williamson LM. Solvent/detergent fresh frozen plasma as primary treatment of acute thrombotic thrombocytopenic purpura. Clin Lab Haematol 1999;21:119-23.
40. Harrison CN, Lawrie AS, Iqbal A, Hunter A, Machin SJ. Plasma exchange with solvent/detergent-treated plasma of resistant thrombotic thrombocytopenic purpura. Br J Haematol 1996;94:756-8.
41. Pehta JC. Clinical studies with solvent detergent-treated products. Transfus Med Rev 1996;10:303-11.
42. Flamholz R, Jeon HR, Baron JM, Baron BW. Study of three patients with thrombotic thrombocytopenic purpura exchanged with solvent/detergent-treated plasma: is its decreased protein S activity clinically related to their development of deep venous thromboses? J Clin Apher 2000;15:169-72.
43. Yarranton H, Cohen H, Pavord SR, et al. Venous thromboembolism associated with the management of acute thrombotic throbocytopenic purpura. Br J Haematol 2003;121:778-85.
44. de la Rubia J, Arriaga F, Linares D, et al. Role of methylene blue-treated or fresh frozen plasma in the response to plasma exchange in patients with thrombotic thrombocytopenic purpura. Br J Haematol 2001;114:721-3.
45. Alvarez-Larran A, Del Rio J, Ramirez C, et al. Methylene blue-photoinactivated plasma vs. fresh frozen plasma as replacement fluid for plasma exchange in thrombotic thrombocytopenic purpura. Vox Sang 2004;86:246-51.
46. McMinn JR, Thomas IA, Terrell DR, et al. Complications of plasma exchange in thrombotic thrombocytopenic purpura-hemolytic uremic syndrome: a study of 78 additional patients. Transfusion 2003;43:415-6.
47. Howard MA, Williams LA, Terrell DR, et al. Complications of plasma exchange in patients treated for clinically suspected thrombotic thrombocytopenic purpura-hemolytic uremic syndrome. III. An additional study of 57 consecutive patients, 2002-2005. Transfusion 2006;46:154-6.
48. Hosler GA, Cusumano AM, Hutchins GM. Thrombotic thrombocytopenic purpura and hemolytic uremic syndrome are distinct pathologic entities: a review of 56 autopsy cases. Arch Pathol Lab Med 2003;127:834-9.