Clinical Trials and Haemovigilance Programmes

The therapeutic efficacy and safety of platelets treated with the INTERCEPT™ Blood System has been demonstrated in 10 randomised clinical trials and through haemovigilance programmes evaluating >300,000 platelet transfusions.

The three main INTERCEPT studies proving equivalence to conventional platelets are:

• The SPRINT trial – Apheresis platelets: The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding. A total of 318 patients were evaluated.
• The EuroSPRITE trial – Pooled buffy coat platelets: The primary end point was the mean 1-hour corrected count increment. A total of 52 patients were evaluated.
• The TESSI trial – Apheresis platelets stored for 6-7 days: The primary end point was the mean 1-hour corrected count increment. A total of 101 patients were evaluated.

Safety in routine use has been demonstrated through haemovigilance programmes evaluating >300,000 platelet transfusions.

• French National Haemovigilance programme - ANSM
• Swiss National Haemovigilance programme – Swissmedic
• Cerus Multicentre Haemovigilance programme

When transfusing INTERCEPT-treated platelet concentrates, you know that safety and efficacy have been demonstrated in multiple randomised, double-blind clinical trials and post-market or hemovigilance studies.