Clinical Trial: A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

Brief Summary:

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).

The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.


Detailed Summary: Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).
Sponsor: Cerus Corporation

Current Primary Outcome:

  • The proportion of patients/transfusions with any Adverse Event or Transfusion Reaction by MedDRA Preferred Term. [ Time Frame: 1 year ]
    The proportion of patients/transfusions with any Adverse Event or Transfusion Reaction by MedDRA Preferred Term, the proportion of patients with a transfusion transmitted Chikungunya virus or Dengue infection
  • The proportion of INTERCEPT Platelet Components containing platelet doses ≥ 3.0 ×1011 platelets. [ Time Frame: 1 year ]
    The proportion of INTERCEPT Platelet Components containing platelet doses ≥ 3.0 ×1011 platelets.
  • The proportion of patients with a transfusion transmitted Chikungunya virus or Dengue infection [ Time Frame: 1 year ]
    The proportion of patients with a transfusion transmitted Chikungunya virus or Dengue infection


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cerus Corporation

Dates:
Date Received: November 25, 2014
Date Started: March 2015
Date Completion:
Last Updated: November 8, 2016
Last Verified: November 2016