RecruitingPhase 1Phase 2NCT04156893
RH Genotype Matched RBC Transfusions
RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease
Sponsor
Children's Hospital of Philadelphia
Enrollment
35 participants
Start Date
Jan 30, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.
Eligibility
Min Age: 6 Months
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
BIOLOGICALRed cell units that are genotype matched at the RHD and RHCE loci
Patients will be provided with red cell units that are C, E, and K antigen matched (standard of care for patients with SCD) and genotype matched at the RHD and RHCE loci.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04156893