title: An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: EFS-Alsace, Strasbourg, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cazenave
authors.forename: Chantal
authors.initials: C
authors.lastname: Waller
authors.forename: Daniel
authors.initials: D
authors.lastname: Kientz
authors.forename: Isabelle
authors.initials: I
authors.lastname: Mendel
authors.forename: Lily
authors.initials: L
authors.lastname: Lin
authors.forename: Michele
authors.initials: M
authors.lastname: Jacquet
authors.forename: Meisa
authors.initials: M
authors.lastname: Propst
authors.forename: Weiqun
authors.initials: W
authors.lastname: Liu
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
authors.forename: David
authors.initials: D
authors.lastname: Sundin
authors.forename: Laurence
authors.initials: L
authors.lastname: Defoin
authors.forename: Nathalie
authors.initials: N
authors.lastname: Messe
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Osselaer
mesh_terms: D000328:Adult; D016913:Blood Component Transfusion; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D004203:Disinfection; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology; D006402:Hematologic Diseases / Q000628:therapy; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011446:Prospective Studies; D014466:Ultraviolet Rays
chemical_list: D011564:Furocoumarins; C118577:amotosalen