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NCT03459287 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
A Phase 3 study, sponsored by Cerus Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 581
- Enrollment target
NCT03459287: Completed Phase 3 study, sponsored by Cerus Corporation.
NCT03459287 is a Phase 3 study that has completed, run by Cerus Corporation. The registered enrollment target is 581 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459287, a Phase 3 study, has completed, sponsored by Cerus Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 581 participants
- Enrollment target
Study 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.
Primary Outcome
Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery.
Interventions
- DEVICE Control
- DEVICE INTERCEPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2024-03-05 |
| Phase | Phase 3 |
What the finished NCT03459287 record still lists
NCT03459287 is an interventional study that assigns participants to a tested intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT03459287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459287 about?
NCT03459287 is a clinical study titled "Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients". 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...
What is the current status of trial NCT03459287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 581 participants. The study started on 2018-12-05. Estimated completion is 2024-03-05.
What interventions are being tested in trial NCT03459287?
The interventions under investigation include: Control (DEVICE), INTERCEPT (DEVICE).
Who is sponsoring clinical trial NCT03459287?
This trial is sponsored by Cerus Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459287's enrollment target sits among peer trials
581 656th of 2000 higher than 1,345 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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