Phase 2
N=43
Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02280655 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline — 4.87; 5.38 percentage of brachial artery diameter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Storage-aged red blood cells (saRBCs) units (Biological); Fresh red blood cells units (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline |
4.87; 5.38 | — |
| PRIMARY Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion |
2.47; 4.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy
- Previous transfusion within one week.
- Inability to give informed consent
- On oral or IV nitrate therapy
- On vasopressor agents
- Active illicit drug use
Data sourced from ClinicalTrials.gov (NCT02280655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.