Status:
TERMINATED
The Impact of Oxidative Stress on Erythrocyte Biology
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease Without Crisis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency have a different lifespan as measured by t...
Detailed Description
This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6PD enzyme deficiency have a different lifespan once transfu...
Eligibility Criteria
Inclusion
- Age 18-60 years
- Has diagnosis of sickle cell disease
- Steady state (no pain or baseline pain and ≥1 month from any hospital admission)
- Receiving chronic transfusions (i.e., regular transfusion every 4-8 weeks).
Exclusion
- History of transfusion reactions not adequately managed by antihistamines
- Does not have crossmatch compatible red cells
- Known G6PD deficiency
- Hepato- or splenomegaly
- Participation in another therapeutic trial
- Pregnant or nursing
- HIV positive
- At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
- Inability to speak and/or read English
Key Trial Info
Start Date :
January 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04028700
Start Date
January 2 2022
End Date
August 16 2024
Last Update
June 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599