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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 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 43 participants.

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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.

Interventions

  • BIOLOGICAL Storage-aged red blood cells (saRBCs) units
  • BIOLOGICAL Fresh red blood cells units

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2009-04
Est. Completion 2013-10
Phase Phase 2

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT02280655

The ClinicalTrials.gov registry entry for NCT02280655 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Storage-aged red blood cells (saRBCs) units is the first listed.

NCT02280655 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.