Understanding genetic risks of immune responses after blood transfusions in sickle cell disease
Official title: Observational Study to Determine Red Blood Cell Alloimmunization Risk Etiology in Patients With Sickle Cell Disease
Run by National Institutes of Health Clinical Center (CC) · NCT06944067 · Data updated 2026-11-12
This study is trying to find out how genetics affect the immune response to blood transfusions in people with sickle cell disease to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 99 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | June 24, 2025 |
| Main results expected | April 10, 2030 |
| Study ends | April 10, 2030 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06944067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals over 2 years of age with a confirmed diagnosis of sickle cell disease and a history of multiple blood transfusions or known genetic variants.
✕Probably not a fit
Patients with impaired decision-making capabilities, those who have undergone transplants, or are currently on immunosuppressive medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the genetic factors that may influence the immune response to blood transfusions in individuals with sickle cell disease (SCD). Researchers will compare the genetic profiles of patients who develop alloimmunization after transfusions with those who do not, focusing on previously identified risk loci and exploring additional candidate loci. The goal is to enhance clinical management and develop targeted therapies for patients susceptible to these immune responses.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with sickle cell disease who are at risk of developing harmful immune responses to blood transfusions.
How similar studies have gone: While this study explores genetic factors in alloimmunization, similar studies have shown promise in understanding immune responses, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA To be eligible to participate in this study, an individual must meet all of the following criteria: 1\. Individual (\> 2 years of age) with confirmed SCD diagnosis who meets at least one of the following conditions: 1. History of greater than ten administered transfusions or 20 transfusion units (where known) 2. History of one or more antibody screens 3. Known candidate variant genotype EXCLUSION CRITERIA An individual who meets any the following criteria will be excluded from participation in this study: 1. Impaired decision-making capability, with or without a legally authorized representative 2. History of transplant (e.g., organ, bone marrow, stem cell) 3. Taking immunosuppressive medications at time of enrollment 4. Confirmed pregnancy
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Neil A Hanchard, M.D. — National Human Genome Research Institute (NHGRI)
- Study coordinator: Emilyn C Banfield
- Email: SCDtransfusionstudy@mail.nih.gov
- Phone: (240) 328-0965
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients
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Newborn Sickle Cell Screening in Mozambique
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Optimizing Hydroxyurea in Children with Sickle Cell in Africa
This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.
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Hematopoietic stem cell editing to treat sickle cell disease
This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.
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Virtual reality options to help with VOC pain in adults with SCD
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.