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

Completed · Phase 2

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02280655

Run by

Emory University

People needed

43

Starts

2009-04-01

Expected to finish

2013-10-01

Last updated by the study team

2016-04-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inpatient or outpatient at Emory University Hospital who's physicians have ordered a transfusion of packed red blood cells (pRBCs) of 1 or more units
• Cardiovascular risk factors (hypercholesterolemia, diabetes, hypertension, and tobacco smoking) or known cardiovascular disease) will be carefully documented for each subject
• Cardiac risk factors are defined as follows:
• Hypercholesterolemia: Defined as serum low density lipoprotein cholesterol > 140 mg/dL if not currently on lipid-lowering therapy or > 100 mg/dL if on lipid-lowering therapy
• Diabetes: Defined as having fasting blood glucose sample of > 126 mg/dL or a hemoglobin A1c of > 7% or being treated with diabetes medications such as oral hypoglycemic agents, insulin sensitizing agents, or subcutaneous insulin
• Smoking: active tobacco use, 20 cigarettes per day for the past year
• Hypertension: Blood pressure of > 140/90 or currently on anti-hypertensive medications
• Cardiovascular disease: known coronary artery disease by angiogram or documented myocardial infarction

You may not qualify if…

• Pregnancy
• Previous transfusion within one week.
• Inability to give informed consent
• On oral or IV nitrate therapy
• On vasopressor agents
• Active illicit drug use

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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