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NCT00991341 · ClinicalTrials.gov registry record · Phase 3
Red Cell Storage Duration Study
A Phase 3 study, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,481
- Enrollment target
NCT00991341: Completed Phase 3 study, sponsored by Carelon Research.
NCT00991341 is a Phase 3 study that has completed, run by Carelon Research. The registered enrollment target is 1,481 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00991341, a Phase 3 study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,481 participants
- Enrollment target
Study Summary
The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.
Primary Outcome
The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die
Interventions
- BIOLOGICAL Red blood cell units stored <= 10 days
- BIOLOGICAL Red blood cell units stored >= 21 days
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,481 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT00991341 record still lists
NCT00991341 is an interventional study that assigns participants to a tested intervention. Its 1,481 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 2 interventions - of which Red blood cell units stored <= 10 days is the first listed.
NCT00991341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00991341 about?
NCT00991341 is a clinical study titled "Red Cell Storage Duration Study". The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinical...
What is the current status of trial NCT00991341?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,481 participants. The study started on 2010-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00991341?
The interventions under investigation include: Red blood cell units stored <= 10 days (BIOLOGICAL), Red blood cell units stored >= 21 days (BIOLOGICAL).
Who is sponsoring clinical trial NCT00991341?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00991341's enrollment target sits among peer trials
1,481 163rd of 2000 higher than 1,838 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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