drugset / Trial / NCT02280655

Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)

NCT02280655 ↗

Phase 2 Completed 43 enrolled Emory University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-04
Primary completion
2012-11
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fresh red blood cells Unknown — —
Comparator Storage-aged red blood cells Unknown — —