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.
Lozano, Miguel 1; Knutson, Folke 2; Tardivel, Rene 3; Cid, Joan 1,4; Maymo, Rosa Maria 4; Lof, Helena 2; Roddie, Huw 5; Pelly, Jane 6; Docherty, Anthony 6; Sherman, Claire 7; Lin, Lily 7; Propst, Meisa 7; Corash, Laurence 7; Prowse, Chris 6
[Article]
British Journal of Haematology.
153(3):393-401, May 2011.
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Summary: 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[middle dot]87 (95% confidence interval: 0[middle dot]73, 1[middle dot]03) demonstrating non-inferiority (P = 0[middle dot]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[middle dot]44, P = 0[middle dot]82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2[middle dot]2 vs. 2[middle dot]3 d, P = 0[middle dot]72). Storage of A-PCs for 6-7 d had no impact on platelet efficacy.
Copyright (C) 2011 Blackwell Publishing Ltd.