Trial Outcomes & Findings for VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained? (NCT NCT02918851)
NCT ID: NCT02918851
Last Updated: 2021-04-08
Results Overview
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
Baseline (prior to receiving blood) and Day 2 after receiving blood
Results posted on
2021-04-08
Participant Flow
42 randomized
Participant milestones
| Measure |
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
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.
|
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
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.
|
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
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Baseline characteristics by cohort
| Measure |
7-day Old RBCs
n=10 Participants
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
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.
|
28-day Old RBCs
n=10 Participants
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
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.
|
42-day Old RBCs
n=10 Participants
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.5 years
n=5 Participants
|
23.5 years
n=7 Participants
|
23 years
n=5 Participants
|
23 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to receiving blood) and Day 2 after receiving bloodPercent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion
Outcome measures
| Measure |
7-day Old RBCs
n=10 Participants
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
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.
|
28-day Old RBCs
n=10 Participants
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
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.
|
42-day Old RBCs
n=10 Participants
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
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.
|
|---|---|---|---|
|
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion
|
10.5 percent change
Interval 0.2 to 17.3
|
8.5 percent change
Interval 2.9 to 13.1
|
10.9 percent change
Interval 5.7 to 16.8
|
SECONDARY outcome
Timeframe: Baseline and Day 2 after transfusionPercent change in duration of exercise from baseline to day 2 after red blood cell transfusion
Outcome measures
| Measure |
7-day Old RBCs
n=10 Participants
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
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.
|
28-day Old RBCs
n=10 Participants
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
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.
|
42-day Old RBCs
n=10 Participants
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
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.
|
|---|---|---|---|
|
Percent Change in Duration of Exercise From Baseline to Day 2 After RBC Transfusion
|
5.4 percent change
Interval 4.1 to 6.9
|
5.4 percent change
Interval 0.2 to 9.2
|
4.9 percent change
Interval 2.0 to 7.2
|
Adverse Events
7-day Old RBCs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
28-day Old RBCs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
42-day Old RBCs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place