Status:
COMPLETED
Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)
Lead Sponsor:
Emory University
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 "f...
Detailed Description
Transfusion of red blood cells (RBCs) is often effective at preventing morbidity and mortality in anemic patients. In contrast, recent studies indicate that some RBC components may have functional def...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Previous transfusion within one week.
- Inability to give informed consent
- On oral or IV nitrate therapy
- On vasopressor agents
- Active illicit drug use
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02280655
Start Date
April 1 2009
End Date
October 1 2013
Last Update
April 11 2016
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322