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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03459287

Public ClinicalTrials.gov record NCT03459287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 12, 2026, 8:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures

Study identification

NCT ID
NCT03459287
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cerus Corporation
Industry
Enrollment
581 participants

Conditions and interventions

Conditions

Interventions

  • Control Device
  • INTERCEPT Device

Device

Eligibility (public fields only)

Age range
11 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 4, 2018
Primary completion
Dec 3, 2023
Completion
Mar 4, 2024
Last update posted
Sep 9, 2025

2018 – 2024

United States locations

U.S. sites
18
U.S. states
13
U.S. cities
18
Facility City State ZIP Site status
University of California Los Angeles Los Angeles California 90095
Stanford Stanford California 94305
University of Colorado Hospital Aurora Colorado 80045
Bridgeport Hospital Bridgeport Connecticut 06610
Yale New Haven Hospital New Haven Connecticut 06510
University of Florida Gainesville Florida 32611
Emory Atlanta Georgia 30308
University of Kentucky Lexington Kentucky 40356
University of Michigan Ann Arbor Michigan 48109
Henry Ford Health System Detroit Michigan 48202
Mayo-Rochester Rochester Minnesota 55905
Duke University Health System Durham North Carolina 27710
Temple Philadelphia Pennsylvania 19140
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
Rhode Island Hospital Providence Rhode Island 02903
University of Texas Southwestern Dallas Texas 75390
Houston Methodist Houston Texas 77030
University of Virginia Health System Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03459287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2025 · Synced May 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03459287 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →