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VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
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.
Details
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 42 |
| Start date | 2017-01 |
| Completion | 2019-11-20 |
Conditions
- Healthy
Interventions
- Transfusion of 7-day stored red blood cells
- Transfusion of 28-day stored red blood cells
- Transfusion of 42-day stored red blood cells
Primary outcomes
- Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion — Baseline (prior to receiving blood) and Day 2 after receiving blood
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion
Countries
United States