title: A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion.
abstract: Bacteria in platelet components (PC) may result in transfusion-related sepsis (TRS). Pathogen inactivation of PC with amotosalen (A-PC) can abrogate the risk of TRS and hence facilitate storage to 7 d. A randomized, controlled, double-blinded trial to evaluate the efficacy and safety of A-PC stored for 6-7 d was conducted. Patients were randomized to receive one transfusion of conventional PC (C-PC) or A-PC stored for 6-7 d. The primary endpoint was the 1 h corrected count increment (CCI) with an acceptable inferiority of 30%. Secondary endpoints included 1- and 24-h count increment (CI), 24-h CCI, time to next PC transfusion, red blood cell (RBC) use, bleeding and adverse events. 101 and 100 patients received A-PC or C-PC respectively. The ratio of 1-h CCI (A-PC:C-PC) was 0·87 (95% confidence interval: 0·73, 1·03) demonstrating non-inferiority (P = 0·007), with respective mean 1-h CCIs of 8163 and 9383; mean 1-h CI was not significantly different. Post-transfusion bleeding and RBC use were not significantly different (P = 0·44, P = 0·82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2·2 vs. 2·3 d, P = 0·72). Storage of A-PCs for 6-7 d had no impact on platelet efficacy.
authors.affiliation: Department of Haemotherapy & Haemostasis, Hospital Clínic Universitari, Villaroel 170, Barcelona, Spain. mlozano@clinic.ub.es
authors.forename: Miguel
authors.initials: M
authors.lastname: Lozano
authors.forename: Folke
authors.initials: F
authors.lastname: Knutson
authors.forename: René
authors.initials: R
authors.lastname: Tardivel
authors.forename: Joan
authors.initials: J
authors.lastname: Cid
authors.forename: Rosa Maria
authors.initials: RM
authors.lastname: Maymó
authors.forename: Helena
authors.initials: H
authors.lastname: Löf
authors.forename: Huw
authors.initials: H
authors.lastname: Roddie
authors.forename: Jane
authors.initials: J
authors.lastname: Pelly
authors.forename: Anthony
authors.initials: A
authors.lastname: Docherty
authors.forename: Claire
authors.initials: C
authors.lastname: Sherman
authors.forename: Lily
authors.initials: L
authors.lastname: Lin
authors.forename: Meisa
authors.initials: M
authors.lastname: Propst
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
authors.forename: Chris
authors.initials: C
authors.lastname: Prowse
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001792:Blood Platelets / Q000187:drug effects* / Q000382:microbiology / Q000528:radiation effects; D001793:Blood Preservation / Q000379:methods*; D016922:Cellular Senescence; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology; D006487:Hemostasis; D006801:Humans; D008297:Male; D050296:Microbial Viability; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D055815:Young Adult
chemical_list: D011564:Furocoumarins; C118577:amotosalen