VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Condition: Healthy
Intervention: Transfusion of 7-day stored red blood cells; Transfusion of 28-day stored red blood cells; Transfusion of 42-day stored red blood cells
Intervention description: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells.; Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells.; Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center, randomized, partially blinded study to determine whether 42-day old
      red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine
      whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to
      oxygen delivery.

      In this study, subjects will be randomized to be transfused with 2 units of autologous (one's
      own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise
      duration and VO2 max (test of oxygen consumption/delivery) between groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity
             exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a
             VO2 max test will be performed, and subjects with a low value (< 35 mL/kg/min) will be
             excluded (screen failure). Based on our previous experience, we anticipate that <10%
             of the subjects will fall into this category

          -  Calculated total blood volume (TBV) ≥4,500 mL using an established formula:

               1. Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV

               2. Women: (0.005835 x H3) + (15 x W) + 183 = TBV [H=height in inches; W=weight in
                  pounds]

          -  Has access to transportation to visit the blood collection facility and to return to
             Stony Brook for all study visits.

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness or problem, including, but not
             limited to, diabetes, hypertension, cardiac disease, asthma, chronic obstructive lung
             disease

          -  Current or recent (last 60 days) tobacco or nicotine use

          -  History of sickle cell trait or disease or any other acquired or hereditary
             hematological abnormality

          -  History of fainting or other significant adverse reaction during phlebotomy or
             donation of blood

          -  Known prolonged corrected QT interval (or evidence of such at screening) on
             electrocardiogram defined as >470 ms

          -  Known or suspected illicit drug or alcohol abuse

          -  Known or suspected HIV, Hepatitis B, or Hepatitis C infection

          -  History of thrombophilia or anticoagulant therapy

          -  Pregnancy

          -  Obesity defined as BMI>30

          -  Recent history of blood donation: a) Single whole blood unit donation within the past
             8 weeks; b) Double RBC donation by apheresis within the past 16 weeks; or c) Plasma
             donation by apheresis within the past 4 weeks

          -  Inadequate RBC mass based on TBV <4500 ml (above) or screening Hb <14 g/dL