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Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients

NCT03459287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2025-09-10

Study results available
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Summary

The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.

Conditions

Interventions

DEVICE

INTERCEPT

Pathogen reduced RBCs

DEVICE

Control

Conventional RBCs

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Principal Investigators

  • Richard J Benjamin, MD · Cerus Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2023-12-04
Completion
2024-03-05
FDA Device
Yes

Countries

  • United States

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 NCT03459287 on ClinicalTrials.gov