Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03459287
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 581 participants
Conditions and interventions
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 Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03459287 live on ClinicalTrials.gov.