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.

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.

Hemovigilance Programs - Demonstrated Safety in Routine Use