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NCT02280655 · ClinicalTrials.gov registry record · Phase 2
Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02280655: Completed Phase 2 study, sponsored by Emory University.
NCT02280655 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02280655, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 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. The purpose of the study is to test the effects of transfusing "aged" versus "fresh" red blood cells in volunteers with traditional cardiovascular risk factors (high blood pressure, diabetes, high cholesterol, and tobacco use) on 1) the degree of relaxation in the arteries and subsequent changes in blood flow, 2) blood levels of oxidant molecules, 3) inflammation, and 4) stem cells. A similar study with healthy volunteers are further described in NCT00838331.
Primary Outcome
Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.
Interventions
- BIOLOGICAL Storage-aged red blood cells (saRBCs) units
- BIOLOGICAL Fresh red blood cells units
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT02280655 record still lists
NCT02280655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Storage-aged red blood cells (saRBCs) units is the first listed.
NCT02280655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02280655 about?
NCT02280655 is a clinical study titled "Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)". 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 NCT02280655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2009-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT02280655?
The interventions under investigation include: Storage-aged red blood cells (saRBCs) units (BIOLOGICAL), Fresh red blood cells units (BIOLOGICAL).
Who is sponsoring clinical trial NCT02280655?
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 NCT02280655's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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