Evaluation of the Efficacy of Platelets Treated With Pathogen Inactivation Process (EFFIPAP)
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Last updated:8th Feb 2013
This study is a multicentre, double-blind, randomized therapeutic trial. The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage: - of platelet concentrates treated by pathogen inactivation (Intercept amotosalen and UVA procedure) - compared with the usual platelet concentrates (in additive solution intersol), reference arm, and - compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS). The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.
|Study start date||2013-02-08|