Phase 4
Completed N=42
VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Healthy
Source: ClinicalTrials.gov NCT02918851 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion — 10.5; 8.5; 10.9 percent change
◆ Published Evidence
Emerging
7citations · ~1 / year
Randomized controlled trial of 7, 28, vs 42 day stored red blood cell transfusion on oxygen delivery (VO<sub>2</sub> max) and exercise duration.
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.
Linked Publications
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Randomized controlled trial of 7, 28, vs 42 day stored red blood cell transfusion on oxygen delivery (VO<sub>2</sub> max) and exercise duration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion |
10.5; 8.5; 10.9 | — |
| SECONDARY Percent Change in Duration of Exercise From Baseline to Day 2 After RBC Transfusion |
5.4; 5.4; 4.9 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02918851) and the linked publication. 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. Informational only — not medical advice.