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

NCT02305732 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2018-10-30

Study results available
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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.

Conditions

  • Chikungunya Virus
  • Dengue Virus

Interventions

BIOLOGICAL

INTERCEPT Platelets

INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.

Sponsors & Collaborators

  • American National Red Cross

    collaborator OTHER

  • Cerus Corporation

    lead INDUSTRY

Principal Investigators

  • Susan L Stramer, PhD · American National Red Cross

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305732 on ClinicalTrials.gov