A multi-center study of therapeutic efficacy and safety of platelet components treated with amotosalen and UVA pathogen inactivation stored for 6 or 7 days prior to transfusion

Miguel Lozano (1) , Folke Knutson (2) , René Tardivel (3) , Joan Cid (1, 4) , Rosa Maria Maymó (4) , Helena Löf (2) , Huw Roddie (5) , Jane Pelly (6) , Anthony Docherty (6) , Claire Sherman (7) , Lily Lin (7) , Meisa Propst (7) , Lawrence Corash (7) , Chris Prowse Prowse (6)

1 Hemotherapy and Hemostasis
2 Clinical Immunology and Transfusion Medicine
3 EFS Bretagne - Etablissement français du sang [Rennes]
4 Component Preparation Unit
5 Haematology
6 Scottish National Blood Transfusion Service
7 Clinical and Regulatory Affairs

Bacteria in platelet components (PC) may result in transfusion related sepsis (TRS). Pathogen inactivation with amotosalen of PC (A-PC) can abrogate the risk of TRS and hence facilitate storage to 7 days. A randomized, controlled, double-blinded trial to evaluate efficacy and safety of A-PC stored for 6-7 days was conducted. Patients were randomized to receive one transfusion of conventional PC (C-PC) or A-PC stored for 6-7 days. The primary endpoint was the 1-hr corrected count increment (CCI) with an acceptable inferiority of 30%. Secondary endpoints included 1 and 24-h CI, 24-hr CCI, time to next PC transfusion, 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% CI: 0.73, 1.03) demonstrating non-inferiority (p = 0.007), with respective mean 1-hr CCI of 8,163 and 9,383 and; mean 1-h CI (109/L) 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 days, p = 0.72). For A-PCs, storage for 6-7 days, had no impact on efficacy.

Mots clés: Medicine

Miguel Lozano, Folke Knutson, René Tardivel, Joan Cid, Rosa Maria Maymó, et al.. A multi-center study of therapeutic efficacy and safety of platelet components treated with amotosalen and UVA pathogen inactivation stored for 6 or 7 days prior to transfusion. British Journal of Haematology, 2011, 153 (3), pp.393. ⟨10.1111/j.1365-2141.2011.08635.x⟩. ⟨hal-00625157⟩