CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Transfusion of 7-day stored red blood cells +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02918851
NCT02918851Phase 4Completed
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VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?

Stony Brook University·interventional·Posted Sep 29, 2016·Updated Apr 8, 2021

In Brief

A Phase 4 clinical trial evaluating Transfusion of 7-day stored red blood cells, Transfusion of 28-day stored red blood cells, and 1 other intervention for Healthy. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 29, 2016
Enrollment StartJan 1, 2017
Primary CompletionAug 9, 2019
Study CompletionNov 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.8 years ago

Interventions

Transfusion of 7-day stored red blood cellsbiological

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.

Transfusion of 28-day stored red blood cellsbiological

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.

Transfusion of 42-day stored red blood cellsbiological

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.