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INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections

NCT03037164 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2026-03-20

No results posted yet for this study

Summary

To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in patients who require RBC transfusion support.

Conditions

Interventions

DEVICE

INTERCEPT Blood System for Red Blood Cells

The pathogen reduction process begins with a unit of RBCs derived from whole blood that is separated according to local regulations and standard operating procedures at the Blood Centers. RBCs are suspended in AS-5 or SAG-M for non-US sites. Leukocyte-reduction of whole blood or RBCs will be performed per manufacturer's instructions. The INTERCEPT Blood System process is performed on a single unit of leukocyte-depleted RBC in AS-5.

DEVICE

Conventional (Control)

Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2026-07-31
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States
  • Puerto Rico
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT03037164 on ClinicalTrials.gov