Clinical trial NCT04028700: The Impact of Oxidative Stress on Erythrocyte Biology
Official title: Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Biology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sickle Cell Disease Without Crisis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

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 transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD deficient, and the lifespan is unknown in the sickle cell population.

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

Primary outcomes:
measure: Percentage of Red Blood Cells Surviving
timeFrame: 24 hours post-transfusion
Secondary outcomes:
measure: Mean Percent Change in Hemoglobin A
timeFrame: 1 hour post-transfusion, 4 weeks post-transfusion
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew Karafin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: