Assessment of safety in neonates for transfusion of platelets and plasma prepared with amotosalen photochemical pathogen inactivation treatment by a 1-month intravenous toxicity study in neonatal rats

Transfusion

Volumn 49, Issue 5, 2009, Pages 985-994

  Lin, Lily ^a   Ciaravino, Vic ^b   Hanover, Jessica ^b   Sullivan, Theresa ^b   Corash, Laurence ^b  

^a CERUS CORPORATION   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMOTOSALEN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BLOOD TRANSFUSION REACTION; BODY WEIGHT; CLINICAL FEATURE; CONTROLLED STUDY; FEMALE; HISTOPATHOLOGY; MALE; NEONATAL THROMBOCYTOPENIA; NEWBORN; NEWBORN CARE; NONHUMAN; PATIENT SAFETY; RAT; SERODIAGNOSIS; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; TOXICOKINETICS; URINALYSIS;

ANIMALS; ANIMALS, NEWBORN; BLOOD COMPONENT TRANSFUSION; PHOTOCHEMICAL PROCESSES; PLATELET TRANSFUSION; PSORALENS; RATS; RISK ASSESSMENT; STERILIZATION;

EID: 65349093430     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2008.02076.x     Document Type: Article

References (42)

1. Strauss RG. Transfusion therapy in neonates. Am J Dis Child 1991 145 : 904 11.
2. Sainio S, Jarvenpaa AL, Renlund M, Riikonen S, Teramo K, Kekomäki R. Thrombocytopenia in term infants: a population-based study. Obstet Gynecol 2000 95 : 441 6.
3. de Moerloose P, Boehlen F, Extermann P, Hohfeld P. Neonatal thrombocytopenia: incidence and characterization of maternal antiplatelet antibodies by MAIPA assay. Br J Haematol 1998 100 : 735 40.
4. Roberts IA, Murray NA. Neonatal thrombocytopenia. Curr Hematol Rep 2006 5 : 55 63.
5. Murray NA, Howarth LJ, McCloy MP, Letsky EA, Roberts IA. Platelet transfusion in the management of severe thrombocytopenia in neonatal intensive care unit patients. Transfus Med 2002 12 : 35 41.
6. Kahn DJ, Richardson DK, Billett HH. Inter-NICU variation in rates and management of thrombocytopenia among very low birth-weight infants. J Perinatol 2003 23 : 312 6.
7. Del Vecchio A, Sola MC, Theriaque DW, Hutson AD, Kao KJ, Wright D, Garcia MG, Pollock BH, Christensen RD. Platelet transfusions in the neonatal intensive care unit: factors predicting which patients will require multiple transfusions. Transfusion 2001 41 : 803 8.
8. Roseff SD, Luban NL, Manno CS. Guidelines for assessing appropriateness of pediatric transfusion. Transfusion 2002 42 : 1398 413.
9. Hilsenrath P, Nemechek J, Widness JA, Cordle DG, Strauss RG. Cost-effectiveness of a limited-donor blood program for neonatal red cell transfusions. Transfusion 1999 39 : 938 43.
10. Strauss RG, Burmeister LF, Johnson K, Cress G, Cordle DG. AS-1 red cells for neonatal transfusions: a randomized trial assessing donor exposure and safety. Transfusion 1996 36 : 873 8.
11. van der Meer PF, Vrielink H, Pietersz RN. Preparation and storage of white blood cell-reduced split apheresis platelet concentrates for pediatric use. Transfusion 2005 45 : 223 7.
12. von Lindern JS, Brand A. The use of blood products in perinatal medicine. Semin Fetal Neonatal Med 2008 13 : 272 81.
13. Klein HG. Will blood transfusion ever be safe enough? JAMA 2000 284 : 238 40.
14. Blajchman MA, Goldman M, Baeza F. Improving the bacteriological safety of platelet transfusions. Transfus Med Rev 2004 18 : 11 24.
15. Goldman M, Blajchman MA. Blood product-associated bacterial sepsis. Transfus Med Rev 1991 V : 73 83.
16. Lin L, Dikeman R, Molini B, Lukehart SA, Lane R, Dupuis K, Metzel P, Corash L. Photochemical treatment of platelet concentrates with amotosalen and UVA inactivates a broad spectrum of pathogenic bacteria. Transfusion 2004 44 : 1496 504.
17. Lin L, Hanson CV, Alter HJ, Jauvin V, Bernard KA, Murthy KK, Metzel P, Corash L. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion 2005 45 : 580 90.
18. Corash L, Lin L. Novel processes for inactivation of leukocytes to prevent transfusion-associated graft-versus-host disease. Bone Marrow Transplant 2004 33 : 1 7.
19. Van Voorhis WC, Barrett LK, Eastman RT, Alfonso R, Dupuis K. Trypanosoma cruzi inactivation in human platelet concentrates and plasma by psoralen (amotosalen HCl) and long-wavelength UV. Antimicrob Agents Chemother 2003 47 : 475 9.
20. Wollowitz S. Fundamentals of the psoralen-based Helinx technology for inactivation of infectious pathogens and leukocytes in platelets and plasma. Sem Hematology 2001 38 Suppl 11 : 4 11.
21. Slichter SJ, Raife TJ, Davis K, Rheinschmidt M, Buchholz DH, Corash L, Conlan MG. Platelets photochemically treated with amotoslaen HCl and ultraviolet A light correct prolonged bleeding times in thrombocytopenic patients. Transfusion 2006 46 : 731 40.
22. van Rhenen D J, Gulliksson H, Cazenave JP, Pamphilon D, Ljungman P, Klüter H, Vermeij H, Kappers-Klunne M, de Greef G, Laforet M, Lioure B, Davis K, Marblie S, Mayaudon V, Flament J, Conlan M, Lin L, Metzel P, Buchholz D, Corash L. Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial. Blood 2003 101 : 2426 33.
23. Janetzko K, Cazenave JP, Kluter H, Kientz D, Michel M, Beris P, Lioure B, Hastka J, Marblie S, Mayaudon V, Lin L, Lin JS, Conlan MG, Flament J. Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set. Transfusion 2005 45 : 1443 52.
24. McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, Stadtmauer EA, Lopez-Plaza I, Coutre S, Strauss RG, Goodnough LT, Fridey JL, Raife T, Cable R, Murphy S, Howard F 4th., Davis K, Lin JS, Metzel P, Corash L, Koutsoukos A, Lin L, Buchholz DH, Conlan MG. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT trial. Blood 2004 104 : 1534 41.
25. Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Lin JS, Corash L, Conlan MG. Clinical safety of platelets photochemically treated with amotoslaen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion 2005 45 : 1864 75.
26. de Alarcon P, Benjamin R, Dugdale M, Kessler C, Shopnick R, Smith P, Abshire T, Hambleton J, Matthew P, Ortiz I, Cohen A, Konkle BA, Streiff M, Lee M, Wages D, Corash L. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation (PCT-FFP): transfusion of patients with congenital factor deficiencies. Transfusion 2005 45 : 1362 72.
27. Mintz PD, Bass NM, Petz LD, Steadman R, Streiff M, McCullough J, Burks S, Wages D, Van Doren S, Corash L. Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease. Blood 2006 107 : 3753 60.
28. Mintz PD, Neff A, MacKenzie M, Goodnough LT, Hillyer C, Kessler C, McCrae K, Menitove JE, Skikne BS, Damon L, Lopez-Plaza I, Rouault C, Crookston KP, Benjamin RJ, George J, Lin JS, Corash L, Conlan MG. A randomized, controlled phase III trial of therapeutic plasma exchange with fresh frozen plasma prepared with amotoslaen and UVA light compared to untreated fresh frozen plasma in thrombotic thrombocytopenic purpura. Transfusion 2006 46 : 1693 704.
29. Osselaer JC, Messe N, Hervig T, Bueno J, Castro E, Espinosa A, Accorsi P, Junge K, Jacquet M, Flament J, Corash L. A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment. Transfusion 2008 48 : 1061 71.
30. Osselaer JC, Cazenave JP, Lambermont M, Garraud O, Hidajat M, Barbolla L, Tardivel R, Defoin L, Waller C, Mendel I, Raidot JP, Kandel G, De Meuter R, Fabrigli P, Dehenau D, Arroyo JL, Padrón F, Gouezec H, Corral M, Jacquet M, Sundin D, Lin L, Corash L. An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment. Vox Sang 2008 94 : 315 23.
31. Cazenave JP, Osselaer JC, Waller C, Jacquet M, Lin L, Corash L, Sundin D. Results from an ongoing hemovigilance program using an electronic data capture system to characterize the safety profile of plasma transfusions prepared with the INTERCEPT Blood System. Vox Sang 2008 95 Suppl 1 : 296.
32. Ciaravino V, McCullough T, Cimino G, Sullivan T. Preclinical safety profile of plasma prepared using the INTERCEPT Blood System. Vox Sanguinis 2003 85 : 171 82.
33. Ciaravino V. Preclinical safety of a nucleic acid-targeted Helinx compound: a clinical perspective. Sem Hematology 2001 38 Suppl 11 : 12 9.
34. Ciaravino V, McCullough T, Dayan AD. Pharmacokinetic and toxicology assessment of INTERCEPT (S-59 and UVA treated) platelets. Hum Exp Toxicol 2001 20 : 533 50.
35. Ciaravino V, McCullough T, Cimino G. The role of toxicology assessment in transfusion medicine. Transfusion 2003 43 : 1481 92.
36. Tice RR, Gatehouse D, Kirkland D, Speit G. The pathogen reduction treatment of platelets with S-59 HCl (amotosalen) plus ultraviolet A light: genotoxicity profile and hazard assessment. Mutat Res 2007 630 : 50 68.
37. 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.
38. Snedecor GW, Cochran WG. Statistical methods. 6th ed. Ames, IA : Iowa State University Press. 1967.
39. Sokal RR, Rohlf FJ. Biometry; the principles and practice of statistics in biological research. San Francisco, CA : W. H. Freeman 1969.
40. Gibson B, Todd A, Roberts I, Pamphilon D, Rodeck C, Bolton-Maggs P, Durbin G. Transfusion guidelines for neonates and older children. Br J Haemat 2004 124 : 433 53.
41. Chakravorty S, Murray N, Roberts I. Neonatal thrombocytopenia. Early Hum Dev 2005 81 : 35 41.
42. Van Haute I, Benoit Y, Bordon V, De Moerloose B, Vandecruys E, Van Lancker S, Van Vooren M, Vandekerckhove B. Therapeutic efficacy and safety of transfusion of pathogen-inactivated platelets to pediatric patients. Vox Sang 2006 91 Suppl 3 : 177.