Trial Outcomes & Findings for The Impact of Oxidative Stress on Erythrocyte Biology (NCT NCT04028700)
NCT ID: NCT04028700
Last Updated: 2025-06-03
Results Overview
Post-Transfusion Recovery
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 hours post-transfusion
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
G6PD Deficient Red Blood Cell Transfusion, Then Non-G6PD Deficient Red Blood Cell Transfusion
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in glucose-6-phosphate-dehydrogenase (G6PD) enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Non-G6PD Deficient Red Blood Cell Transfusion, Then G6PD Deficient Red Blood Cell Transfusion,
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
|---|---|---|
|
Initial Intervention
STARTED
|
3
|
5
|
|
Initial Intervention
COMPLETED
|
3
|
5
|
|
Initial Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Months)
STARTED
|
3
|
5
|
|
Washout (4 Months)
COMPLETED
|
3
|
5
|
|
Washout (4 Months)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
0
|
0
|
|
Second Intervention
COMPLETED
|
0
|
0
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Oxidative Stress on Erythrocyte Biology
Baseline characteristics by cohort
| Measure |
G6PD Deficient Red Blood Cell Transfusion, Then Non-G6PD Deficient Red Blood Cell Transfusion
n=3 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Non-G6PD Deficient Red Blood Cell Transfusion, Then G6PD Deficient Red Blood Cell Transfusion,
n=5 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-transfusionPost-Transfusion Recovery
Outcome measures
| Measure |
G6PD Deficient Red Blood Cell Transfusion
n=3 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity.
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Non-G6PD Deficient Red Blood Cell Transfusion
n=5 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
|---|---|---|
|
Percentage of Red Blood Cells Surviving
|
82.91 percentage of surviving red cells
Standard Deviation 5.57
|
91.03 percentage of surviving red cells
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: 1 hour post-transfusion, 4 weeks post-transfusionHemoglobin A
Outcome measures
| Measure |
G6PD Deficient Red Blood Cell Transfusion
n=3 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity.
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Non-G6PD Deficient Red Blood Cell Transfusion
n=5 Participants
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
|---|---|---|
|
Mean Percent Change in Hemoglobin A
|
25.87 Percentage of Hemoglobin A
Standard Deviation 8.14
|
21.02 Percentage of Hemoglobin A
Standard Deviation 3.55
|
Adverse Events
G6PD Deficient Red Blood Cell Transfusion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-G6PD Deficient Red Blood Cell Transfusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
G6PD Deficient Red Blood Cell Transfusion
n=3 participants at risk
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity.
G6PD Deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
Non-G6PD Deficient Red Blood Cell Transfusion
n=5 participants at risk
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
Non-G6PD deficient Red Blood Cell Transfusion: Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
|
|---|---|---|
|
Cardiac disorders
Shortness of Breath due to Heart Palpitations
|
33.3%
1/3 • Number of events 3 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
0.00%
0/5 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
20.0%
1/5 • Number of events 1 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
20.0%
1/5 • Number of events 1 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy Nose
|
33.3%
1/3 • Number of events 1 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
0.00%
0/5 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Headache
|
33.3%
1/3 • Number of events 1 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
0.00%
0/5 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Number of events 1 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
0.00%
0/5 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
0.00%
0/5 • From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.
|
Additional Information
Matthew S. Karafin MD MS
University of North Carollina at Chapel Hill
Phone: 984-974-1583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place