title: A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment.
abstract: BACKGROUND
  Inactivation of pathogens and white blood cells in platelet (PLT) components with amotosalen and UVA light (INTERCEPT, Cerus Europe BV) has entered clinical practice in European blood centers. A prospective cohort study was implemented to characterize the safety profile of this new PLT component in a broad patient population.
  
  
  METHODS
  Apheresis or buffy-coat PLT components were leukoreduced, suspended in approximately 35 percent plasma and 65 percent PLT additive solution, and treated with the INTERCEPT process. Blood centers were requested to complete a safety data form after each transfusion.
  
  
  RESULTS
  Data for 5106 INTERCEPT components administered to 651 patients were monitored. A total of 5051 (98.9%) transfusions and 609 (93.5%) patients had no reported reactions. Fifty-five (1.1%) transfusions were associated with adverse events, and 42 (0.8%) were possibly, probably, or related to the PLT transfusion. Adverse events occurred in 42 (6.4%) patients, but in only 32 (4.9%) patients was a causal relationship to PLT transfusion established. One reaction was serious, and no deaths were related to PLT transfusion. Among the transfusions reactions, the most frequent clinical events in descending frequency were chills, fever, dermatologic reactions, dyspnea, nausea or vomiting, and hypotension. No episodes of transfusion-related acute lung injury were reported.
  
  
  CONCLUSIONS
  In this cohort study, 99.2 percent of transfusions were without reactions attributed to PLTs. INTERCEPT PLTs exhibited a safety profile similar to that previously reported for conventional PLT components.
authors.affiliation: Blood Transfusion Center, Cliniques Universitaires de Mont Godinne, Université Catholique de Louvain, Yvoir, Belgium.
authors.forename: Jean C
authors.initials: JC
authors.lastname: Osselaer
authors.forename: Nathalie
authors.initials: N
authors.lastname: Messe
authors.forename: Tor
authors.initials: T
authors.lastname: Hervig
authors.forename: Jose
authors.initials: J
authors.lastname: Bueno
authors.forename: Emma
authors.initials: E
authors.lastname: Castro
authors.forename: Aurora
authors.initials: A
authors.lastname: Espinosa
authors.forename: Patrizia
authors.initials: P
authors.lastname: Accorsi
authors.forename: Klaus
authors.initials: K
authors.lastname: Junge
authors.forename: Michele
authors.initials: M
authors.lastname: Jacquet
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Flament
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000187:drug effects* / Q000382:microbiology / Q000528:radiation effects*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D004364:Pharmaceutical Preparations; D010777:Photochemistry; D017713:Platelet Transfusion / Q000009:adverse effects / Q000379:methods*; D012307:Risk Factors; D012449:Safety; D018805:Sepsis / Q000382:microbiology
chemical_list: D004364:Pharmaceutical Preparations