Clinical trial
Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Biology
Name
21-0587
Description
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 the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6PD enzyme deficiency.
Trial arms
Trial start
2022-01-02
Estimated PCD
2024-10-31
Trial end
2024-10-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion, Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,
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.
Arms:
G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion, Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,
Size
16
Primary endpoint
Percentage of Red Blood Cells Surviving
24 hours post-transfusion
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will not be told which type of blood they are receiving first. There is no way to tell if blood has enzyme deficiencies by looking at it.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}
Updated at
2024-04-11
1 organization
2 products
1 indication
Organization
University of North Carolina, Chapel HillIndication
Sickle Cell Disease Without Crisis