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
2011 (English)In: British Journal of Haematology, ISSN 0007-1048, E-ISSN 1365-2141, Vol. 153, no 3, 393-401 p.Article in journal (Refereed) Published
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 center dot 87 (95% confidence interval: 0 center dot 73, 1 center dot 03) demonstrating non-inferiority (P = 0 center 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 center dot 44, P = 0 center dot 82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2 center dot 2 vs. 2 center dot 3 d, P = 0 center dot 72). Storage of A-PCs for 6-7 d had no impact on platelet efficacy.
Place, publisher, year, edition, pages
2011. Vol. 153, no 3, 393-401 p.
transfusion medicine, platelet transfusion, pathogen inactivation, amotosalen, platelet storage
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-153302DOI: 10.1111/j.1365-2141.2011.08635.xISI: 000289364700012PubMedID: 21418180OAI: oai:DiVA.org:uu-153302DiVA: diva2:416007