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

Br J Haematol. 2011 May;153(3):393-401 doi: 10.1111/j.1365-2141.2011.08635.x.
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.

Metadata
MESH HEADINGS: Adolescent; Adult; Aged; Blood Platelets; Blood Preservation; Cellular Senescence; Double-Blind Method; Erythrocyte Transfusion; Female; Furocoumarins; Hemostasis; Humans; Male; Microbial Viability; Middle Aged; Platelet Count; Platelet Transfusion; Prospective Studies; Time Factors; Treatment Outcome; Ultraviolet Rays; Young Adult
Study Details
Study Design: Randomised Controlled Trial
Credits: Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine