TerminatedPhase 2

The Impact of Oxidative Stress on Erythrocyte Biology

Stopped: Funding not renewed

United States8 participantsStarted 2022-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Red Blood Cells Surviving

Timeframe: 24 hours post-transfusion

Trial details

NCT IDNCT04028700

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-18

Results submitted2025-05-15

View on ClinicalTrials.gov More Sickle Cell Disease Without Crisis trials