title: An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment.
abstract: BACKGROUND
  An active haemovigilance programme was implemented to survey adverse events (AE) associated with transfusion of platelets photochemically treated with amotosalen and ultraviolet A (PCT-PLT). The results of 5106 transfusions have already been reported. Here we report the results of an additional 7437 PCT-PLT transfusions.
  
  
  METHODS
  The focus of this ongoing haemovigilance programme is to document all AEs associated with PCT-PLT transfusion. Data collected for AEs include: time of event after starting transfusion, clinical descriptions, vital signs, results from radiographs and bacterial cultures, event severity (Grade 0-4) and causal relationship to PCT-PLT transfusion.
  
  
  RESULTS
  One thousand four hundred patients (mean 60 years, range 1-96) received PCT-PLT transfusions. The majority of the patients (53.4%) had haematology-oncology diseases and required conventional chemotherapy (44.8%) or stem cell transplantation (8.6%). Sixty-eight PCT-PLT transfusions were associated with AE. Acute transfusion reactions (ATR), classified as an AE possibly related, probably related, or related to PCT-PLT transfusions were infrequent (n = 55, 55/7437 = 0.7%) and most were of Grade 1 severity. Thirty-nine patients (39/1400 = 2.8%) experienced one or more ATRs. The most frequently reported signs/symptoms were chills, fever, urticaria, dyspnoea, nausea and vomiting. Five AEs were considered severe (> or = Grade 2); however, no causal relationship to PCT-PLT transfusion was found. Repeated exposure to PCT-PLT did not increase the likelihood of an ATR. No cases of transfusion-related acute lung injury and no deaths due to PCT-PLT transfusions were reported.
  
  
  CONCLUSIONS
  Routine transfusion of PCT-PLT is well-tolerated in a wide range of patients. ATRs related to PCT-PLT transfusion were infrequent and most were of mild severity.
authors.affiliation: Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Universite Catholique de Louvain, Yvoir, Belgium.
authors.forename: J C
authors.initials: JC
authors.lastname: Osselaer
authors.forename: J P
authors.initials: JP
authors.lastname: Cazenave
authors.forename: M
authors.initials: M
authors.lastname: Lambermont
authors.forename: O
authors.initials: O
authors.lastname: Garraud
authors.forename: M
authors.initials: M
authors.lastname: Hidajat
authors.forename: L
authors.initials: L
authors.lastname: Barbolla
authors.forename: R
authors.initials: R
authors.lastname: Tardivel
authors.forename: L
authors.initials: L
authors.lastname: Defoin
authors.forename: C
authors.initials: C
authors.lastname: Waller
authors.forename: I
authors.initials: I
authors.lastname: Mendel
authors.forename: J P
authors.initials: JP
authors.lastname: Raidot
authors.forename: G
authors.initials: G
authors.lastname: Kandel
authors.forename: R
authors.initials: R
authors.lastname: De Meuter
authors.forename: P
authors.initials: P
authors.lastname: Fabrigli
authors.forename: D
authors.initials: D
authors.lastname: Dehenau
authors.forename: J L
authors.initials: JL
authors.lastname: Arroyo
authors.forename: F
authors.initials: F
authors.lastname: Padrón
authors.forename: H
authors.initials: H
authors.lastname: Gouezec
authors.forename: M
authors.initials: M
authors.lastname: Corral
authors.forename: M
authors.initials: M
authors.lastname: Jacquet
authors.forename: D
authors.initials: D
authors.lastname: Sundin
authors.forename: L
authors.initials: L
authors.lastname: Lin
authors.forename: L
authors.initials: L
authors.lastname: Corash
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets; D001793:Blood Preservation / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D005260:Female; D011564:Furocoumarins / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D017319:Photosensitizing Agents / Q000627:therapeutic use; D017713:Platelet Transfusion / Q000009:adverse effects*; D011446:Prospective Studies; D014466:Ultraviolet Rays
chemical_list: D011564:Furocoumarins; D017319:Photosensitizing Agents; C118577:amotosalen