Matching donor red blood cells by RH genotype for sickle cell disease patients
RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease
PHASE1; PHASE2 · Children's Hospital of Philadelphia · NCT04156893
This study is testing if matching red blood cell transfusions to the RH genotype can help people with sickle cell disease who need regular transfusions feel better and have fewer complications.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04156893 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 trial aims to assess the feasibility and efficacy of using RH genotype-matched red blood cell transfusions for patients with Sickle Cell Disease (SCD) who require chronic transfusions. The study will utilize RH genotyped donor units from the New York Blood Center, ensuring that patients receive transfusions that minimize foreign Rh protein exposure. Participants will be monitored for Rh alloantibody formation during their transfusion therapy, which will last up to three years. The trial seeks to improve upon the current standard of care by providing a higher level of red cell matching.
Who should consider this trial
Good fit: Ideal candidates include individuals over 6 months old diagnosed with Sickle Cell Disease who require chronic red cell transfusion therapy.
Not a fit: Patients with rare RH genotypes or those who are alloimmunized to the D antigen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of alloimmunization and improve transfusion outcomes for patients with Sickle Cell Disease.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving transfusion compatibility and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects age \>6 months * Diagnosis of SCD, all genotypes * Require a period of chronic red cell transfusion therapy * Subject/parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria: * Rare RH genotype that would preclude identification of sufficient RBC units * Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units * Alloimmunized to D antigen * Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols * Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Stella Chou, MD — Children's Hospital of Philadelphia
- Study coordinator: Stella Chou, MD
- Email: chous@chop.edu
- Phone: 215-590-0947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cells Disease, Chronic Transfusion