VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
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|ClinicalTrials.gov Identifier: NCT02918851|
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : April 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: 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||Phase 4|
The US Food and Drug Administration (FDA) regulations permit additive-containing RBCs to be stored for up to 42 days prior to transfusion. However, RBCs progressively develop abnormalities during storage. The efficacy of older stored blood, i.e., effective oxygen delivery, has not been established in rigorous controlled studies. Due to pragmatic reasons, a large clinical trial that randomizes patients to "old" blood may not be feasible.
Every subject will have 2 phlebotomy visits at Stony Brook University Hospital. Subjects randomized to the 7- and 42-day old groups will have 2 units of blood removed at Week 0 and another 2 units removed at Week 5. However, the remaining 28-day group will have 2 units of blood removed at Week 2 and only 1 unit of blood removed at Week 5. During week 6, each subjects will have 3 study visits: 1) On Monday, a VO2 max test; 2) On Wednesday, a transfusion with 2 units of autologous RBCs (each over 1 hour), followed by a VO2 max test 2 hours later; 3) On Friday, a VO2 max test will be done in order to calculate a delta VO2 max (Friday minus Monday results).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: 7-day old RBCs
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
Biological: Transfusion of 7-day stored red blood cells
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.
Experimental: 28-day old RBCs
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
Biological: Transfusion of 28-day stored red blood cells
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.
Experimental: 42-day old RBCs
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
Biological: Transfusion of 42-day stored red blood cells
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.
- Change in maximal oxygen uptake (VO2 max) [ Time Frame: 5-20 minutes into standardized exercise protocol, at week 6 ]Maximal oxygen uptake (VO2 max) is the maximum rate at which the body can consume and use oxygen, calculated via exhaustion from exercise on a treadmill or cycle ergometer with direct measurement of O2 consumption using a metabolic cart to analyze inspired and expired gases. The primary outcomes of this study are the change in VO2 max from Monday to Friday of week 6, after receiving 7-, 28-, or 42-day old blood on the Wednesday of Week 6.
- Change in duration of exercise [ Time Frame: On Monday, Wednesday and Friday of week 6 ]This secondary outcome is the change in duration of exercise between assessments. Differences in these changes will be compared between groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918851
|Contact: Sabeen Rizwanfirstname.lastname@example.org|
|United States, New York|
|Stony Brook Medicine||Recruiting|
|Stony Brook, New York, United States, 11794-8480|
|Contact: Elliott Bennett-Guerrero, MD 631-444-6026 email@example.com|
|Principal Investigator:||Elliott Bennett-Guerrero, MD||Stony Brook University|