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NCT00838331 · ClinicalTrials.gov registry record · Phase 2
Adverse Effects of RBC Transfusions: A Unifying Hypothesis
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00838331: Completed Phase 2 study, sponsored by Emory University.
NCT00838331 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00838331, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
Transfusion of red blood cells is often used in critically ill patients with low red blood cell counts to prevent disease progression and death. Recent studies suggest that the use of "aged" versus "fresh" red blood cells are associated with worse clinical outcomes. There is evidence that red blood cells work with the cells lining our blood vessels to produce a variety of substances that normally cause arteries to relax and increase blood supply. Two of these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing factor (EDHF). The investigators are trying to determine the nature of these substances in human beings when they are transfused "aged" versus "fresh" red blood cells. It is their thought that "aged" red blood cells have less of the substances (NO and EDHF) that naturally relax our arteries and further changes the blood supply. One way to determine this is to transfuse a subject's own "aged" and "fresh" red blood cells and inject substances such as L-NMMA (L-NG monomethyl arginine) and TEA (tetraethylammonium chloride), which block the production of NO and EDHF respectively, and then, study what happens to the blood flow. There is evidence that red blood cells produce NO, which normally causes arteries to relax and increase blood supply. The investigators will try to determine the nature of NO in red blood cells and whether the amount of this substance is altered because of different blood processing and storage techniques. It is their thought that "aged" red blood cells have less NO that naturally relaxes our arteries and further changes the blood supply. This study is designed to determine the most ideal way of storing and processing blood.
Primary Outcome
The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.
Interventions
- BIOLOGICAL Fresh blood
- BIOLOGICAL Aged blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT00838331 record still lists
NCT00838331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Fresh blood is the first listed.
NCT00838331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00838331 about?
NCT00838331 is a clinical study titled "Adverse Effects of RBC Transfusions: A Unifying Hypothesis". Transfusion of red blood cells is often used in critically ill patients with low red blood cell counts to prevent disease progression and death. Recent studies suggest that the use of "aged" versus "fresh" red blood cells are associated with worse clinical outcomes. There is evidence that red blood ...
What is the current status of trial NCT00838331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2009-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00838331?
The interventions under investigation include: Fresh blood (BIOLOGICAL), Aged blood (BIOLOGICAL).
Who is sponsoring clinical trial NCT00838331?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00838331's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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