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An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment.

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Cazenave, Jean-Pierre Waller, Chantal Kientz, Daniel Mendel, Isabelle Lin, Lily Defoin, Laurence [UCL] Osselaer, Jean-Claude [MONT]

BACKGROUND: Photochemical pathogen inactivation treatment (PCT) of plasma components with amotosalen and UVA has been implemented in Europe. To establish a postapproval safety database, an active hemovigilance (HV) program utilizing an electronic data capture system (EDCS) was initiated. STUDY DESIGN AND METHODS: The response to transfusion was documented after each PCT-plasma transfusion. The primary outcome was the incidence of acute transfusion reactions (ATRs) within 24 hours of transfusion. An ATR was defined as an adverse event (AE) possibly related, probably related, or related to the PCT-plasma transfusion. For AEs, the following were collected: time of event after transfusion, clinical description, vital signs, clinical and laboratory test results, severity (Grade 0-4), seriousness, and causal relationship to transfusion of PCT-plasma. RESULTS: To date, 3232 patients (59.1% male) with a primary indication for plasma transfusion due to a hematology disorder (23.1%), surgery (32.4%), or a general medical condition (44.4%) received 7483 PCT-plasma transfusions (composed of 19,069 apheresis plasma components). The mean age of the patient population was 57.3 years (2884 adults, 160 children, and 188 infants). ATRs were reported for 8/7483 transfusions (0.11%; 95% confidence interval [CI], 0.03-0.19) and 8/3232 patients (0.25%; 95% CI, 0.08-0.42%). Five ATRs were of Grade 1 severity. The remaining three ATRs were classified as serious. No deaths or episodes of transfusion-related acute lung injury attributed to a PCT-plasma transfusion were reported. CONCLUSION: PCT-plasma transfusions were well tolerated in routine clinical use. The EDCS HV program facilitated collection and reporting of safety information on a real-time basis from multiple sites.

Document type Article de périodique (Journal article) – Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
Publication date 2010
Journal information "Transfusion" - Vol. 50, no. 6, p. 1210-9 (2010)
Peer reviewed yes
e-issn 1537-2995
issn 0041-1132
Publication status Publié
Affiliations UCL - SSS/IREC/MONT - Pôle Mont Godinne
UCL - (MGD) Service d'hématologie
UCL - (MGD) Centre de transfusion sanguine
MESH Subject Ultraviolet Rays ; Psoralens - pharmacology ; Prospective Studies ; Plasma ; Middle Aged ; Male ; Infant ; Humans ; Hematologic Diseases - therapy ; Female ; Disinfection ; Databases, Factual ; Child, Preschool ; Child ; Blood Component Transfusion ; Adult
Links
  1. Singh, Transfusion, 46, 1168 (2006)
  2. Grass, Blood, 91, 2180 (1998)
  3. Grellier, Transfusion, 48, 1676 (2008)
  4. Wollowitz, Semin Hematol, 38, 4 (2001)
  5. Hambleton, Transfusion, 42, 1302 (2002)
  6. De Alarcon Pedro, Benjamin Richard, Dugdale Marion, Kessler Craig, Shopnick Rinah, Smith Peter, Abshire Thomas, Hambleton Julie, Matthew Prasad, Ortiz Idith, Cohen Alice, Konkle Barbara A., Streiff Michael, Lee Martin, Wages David, Corash Laurence, Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies : PCT-FFP FOR COAGULATION FACTOR DEFICIENCIES, 10.1111/j.1537-2995.2005.00216.x
  7. Mintz, Blood, 107, 3753 (2006)
  8. Mintz, Transfusion, 46, 1693 (2006)
  9. Andreu, Transfusion, 42, 1356 (2002)
  10. Faber, Blood transfusion in Europe, 213 (2005)
  11. Schlenke, Transfusion, 48, 697 (2008)
  12. Osselaer, Transfusion, 48, 1061 (2008)
  13. Osselaer, Vox Sang, 94, 315 (2008)
  14. Ware, N Engl J Med, 342, 1334 (2000)
  15. Council of Europe, Guide to the preparation, use and quality assurance of blood components (2007)
  16. MacLennan, Best Pract Res Clin Haematol, 19, 169 (2006)
  17. Bettmann M A, Heeren T, Greenfield A, Goudey C, Adverse events with radiographic contrast agents: results of the SCVIR Contrast Agent Registry., 10.1148/radiology.203.3.9169677
  18. Alving, Blood banking and transfusion medicine, 307 (2003)
  19. Rodgers, Wintrobe's clinical hematology, 1682 (1999)
  20. Dodd, Curr Opin Hematol, 14, 671 (2007)
  21. Biggerstaff, Transfusion, 43, 1007 (2003)
  22. Linnen, Transfusion, 48, 1355 (2008)
  23. Likos, Transfusion, 47, 1080 (2007)
  24. Brouard, Transfusion, 48, 1333 (2008)
  25. Stainsby, Transfus Med Rev, 20, 273 (2006)
  26. Chapman, Transfusion, 49, 440 (2009)
Bibliographic reference Cazenave, Jean-Pierre ; Waller, Chantal ; Kientz, Daniel ; Mendel, Isabelle ; Lin, Lily ; et. al. An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment.. In: Transfusion, Vol. 50, no. 6, p. 1210-9 (2010)
Permanent URL http://hdl.handle.net/2078.1/29214