Safety and clinical efficacy of platelet components prepared with pathogen inactivation in routine use for thrombocytopenic patients.

ABSTRACT

This study was conducted to evaluate the safety and efficacy of platelet concentrates (PC) after photochemical treatment (PCT) with the INTERCEPT Blood System™ and transfused in routine use in a population of patients suffering from a variety of hematological diseases. This was an observational, single-arm, open-label study of pooled buffy-coat PC (n=298) or apheresis PC (n=262) treated with INTERCEPT™ and transfused to 51 thrombocytopenic hematology patients. PCT replaced CMV screening and gamma irradiation, and made optional bacterial testing obsolete. The primary study endpoint was the incidence of acute transfusion reactions (ATR). Secondary endpoints included bleeding assessment, platelet count increments, and adverse events (AE). For the 553 transfusions, a total of 55 AE were observed regardless of relationship to platelet transfusion. Ten AE associated with nine transfusions met the criteria for ATR (1.6%). All ATRs were grade 1. Twelve serious AE were reported in 10 patients, none was related to platelet transfusion. Mean 24-h CI and CCI were 10.9 × 10(9) and 6.6 × 10(3)/L, respectively. No bleeding complications were attributable to the INTERCEPT-treated PC. This study confirms safety and efficacy of pathogen inactivated PC for support of thrombocytopenia and demonstrated that INTERCEPT technology can easily be implemented in routine operations.