A Phase 2 interventional study of G6PD Deficient Red Blood Cell Transfusion and Non-G6PD deficient Red Blood Cell Transfusion in Sickle Cell Disease Without Crisis, sponsored by University of North Carolina, Chapel Hill. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Basic science
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.
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
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.
Biological: G6PD Deficient Red Blood Cell Transfusion · Biological: Non-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
Biological: G6PD Deficient Red Blood Cell Transfusion · Biological: 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.
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
Post-Transfusion Recovery
Time frame: 24 hours post-transfusion
Mean Percent Change in Hemoglobin A
Hemoglobin A
Time frame: 1 hour post-transfusion, 4 weeks post-transfusion
| Milestone | 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, |
|---|---|---|
| Started | 3 | 5 |
| Completed | 3 | 5 |
| Not completed | 0 | 0 |
| Milestone | 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, |
|---|---|---|
| Started | 3 | 5 |
| Completed | 3 | 5 |
| Not completed | 0 | 0 |
| Milestone | 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, |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
Post-Transfusion Recovery
| percentage of surviving red cells | G6PD Deficient Red Blood Cell Transfusion | Non-G6PD Deficient Red Blood Cell Transfusion |
|---|---|---|
| Percentage of Red Blood Cells Surviving | 82.91 ± 5.57 | 91.03 ± 3.90 |
Hemoglobin A
| Percentage of Hemoglobin A | G6PD Deficient Red Blood Cell Transfusion | Non-G6PD Deficient Red Blood Cell Transfusion |
|---|---|---|
| Mean Percent Change in Hemoglobin A | 25.87 ± 8.14 | 21.02 ± 3.55 |
Collected over From the time of chromium infusion until the end the last blood draw, a total of approximately 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| G6PD Deficient Red Blood Cell Transfusion | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Non-G6PD Deficient Red Blood Cell Transfusion | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Event | G6PD Deficient Red Blood Cell Transfusion | Non-G6PD Deficient Red Blood Cell Transfusion |
|---|---|---|
| Shortness of Breath due to Heart PalpitationsCardiac disorders | 1/3 | 0/5 |
| Stuffy NoseRespiratory, thoracic and mediastinal disorders | 1/3 | 0/5 |
| Sinus HeadacheRespiratory, thoracic and mediastinal disorders | 1/3 | 0/5 |
| Back PainMusculoskeletal and connective tissue disorders | 1/3 | 0/5 |
| FatigueGeneral disorders | 1/3 | 0/5 |
| NauseaGastrointestinal disorders | 0/3 | 1/5 |
| VomitingGastrointestinal disorders | 0/3 | 1/5 |
| Age, Categorical(Participants) | 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, | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 2 | 5 | 7 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 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, | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | 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, | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 5 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 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, | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 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, | Total |
|---|---|---|---|
| United States | 3 | 5 | 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap, Icf
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University of North Carolina, Chapel Hill