Phase 4 N=42 Randomized Single-blind Other

VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02918851 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion — 10.5; 8.5; 10.9 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Transfusion of 7-day stored red blood cells (Biological); Transfusion of 28-day stored red blood cells (Biological); Transfusion of 42-day stored red blood cells (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Stony Brook University
Primary completion: Aug 2019

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	—

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 ( 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

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Data sourced from ClinicalTrials.gov (NCT02918851). 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.