Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Storage-aged red blood cells (saRBCs) units; Fresh red blood cells units
Intervention description: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD); Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Blood Transfusions

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