Rejuvenated RBC and VO2 Max in Healthy Subjects

Stopped early · Phase 4

Conditions studied: Erythrocyte Transfusion

In brief

To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), we will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. Maximal oxygen uptake (VO2max) will be measured in an anemic, post-donation, pre-transfusion state, and also after transfusing 14-day-old, autologous blood randomized to standard storage or standard storage with rejuvenation. We hypothesize that transfusion of standard PRBCs is less effective at increasing oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs.

Key facts

Study ID

NCT03089047

Run by

Duke University

People needed

9

Starts

2017-09-29

Expected to finish

2018-04-18

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female
• Age 18-40 (the American College of Sports Medicine Guidelines for Exercise Testing defines this age group with no or no more than one coronary heart disease risk factor as low-risk for VO2 max testing)
• 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 up to 25% of the subjects will fall into this category; therefore, 10 subjects will be screened to obtain 6-8 participants who go on to donate their blood.
• Calculated total blood volume of at least 4,500 mL using an established formula:
• Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
• 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 Duke for all study visits
• Weighs at least 130 pounds

You may not qualify if…

• Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, COPD
• 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 QTc (or evidence of such at screening) defined as QTc >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:
• Single whole blood unit donation within the past 8 weeks
• Double RBC donation by apheresis within the past 16 weeks
• Plasma donation by apheresis within the past 4 weeks
• Inadequate red blood cell mass evidenced by total blood volume <4500 mL (above) or screening hemoglobin <13.3 g/dL
• Known hypersensitivity to lithium compounds.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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