Trial Outcomes & Findings for Rejuvenated RBC and VO2 Max in Healthy Subjects (NCT NCT03089047)
NCT ID: NCT03089047
Last Updated: 2021-01-11
Results Overview
Change in VO2max from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Day 16 to Day 18 post transfusion
Results posted on
2021-01-11
Participant Flow
3 subjects failed to meet baseline VO2max threshold, 1 had a below threshold hemoglobin prior to blood donation, and 1 enrolled in another study before completing baseline VO2max.
Participant milestones
| Measure |
Rejuvenated RBC Transfusion
Washed and Rejuvenated autologous blood
Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
|
Standard RBC Transfusion
Washed autologous blood (so as to maintain equivalent unit volume and Hct)
Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Rejuvenated RBC Transfusion
Washed and Rejuvenated autologous blood
Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
|
Standard RBC Transfusion
Washed autologous blood (so as to maintain equivalent unit volume and Hct)
Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Rejuvenated RBC and VO2 Max in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Rejuvenated RBC Transfusion
n=1 Participants
Washed and Rejuvenated autologous blood
Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
|
Standard RBC Transfusion
n=2 Participants
Washed autologous blood (so as to maintain equivalent unit volume and Hct)
Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
VO2max
|
44.80 ml/kg/min
STANDARD_DEVIATION 0 • n=5 Participants
|
49.15 ml/kg/min
STANDARD_DEVIATION 9.97 • n=7 Participants
|
47.70 ml/kg/min
STANDARD_DEVIATION 7.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 16 to Day 18 post transfusionPopulation: Subjects who completed the study.
Change in VO2max from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max.
Outcome measures
| Measure |
Rejuvenated RBC Transfusion
n=1 Participants
Washed and Rejuvenated autologous blood
Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
|
Standard RBC Transfusion
n=2 Participants
Washed autologous blood (so as to maintain equivalent unit volume and Hct)
Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
|
|---|---|---|
|
Change in VO2max
|
0.70 ml/kg/min
Standard Deviation 0
|
6.05 ml/kg/min
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: Day 16 to Day 18 post transfusionPopulation: Data not collected.
Change in lactate from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 18 post transfusionPopulation: Subjects who completed the study.
Change in "post-Tx" (after transfusion) VO2max at day 18 from baseline.
Outcome measures
| Measure |
Rejuvenated RBC Transfusion
n=1 Participants
Washed and Rejuvenated autologous blood
Transfusion of rejuvenated and washed autolgous RBCs: Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
|
Standard RBC Transfusion
n=2 Participants
Washed autologous blood (so as to maintain equivalent unit volume and Hct)
Transfusion of washed autolgous RBCs: Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
|
|---|---|---|
|
Change in "Post-Tx" VO2max From Baseline
|
-1.90 ml/kg/min
Standard Deviation 0
|
-2.70 ml/kg/min
Standard Deviation 2.40
|
Adverse Events
Rejuvenated RBC Transfusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard RBC Transfusion
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