RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
RH Genotype Matched RBC Transfusions
RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease
About This Trial
To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.
Who May Be Eligible (Plain English)
Who May Qualify:
- Subjects age \>6 months
- Diagnosis of SCD, all genotypes
- Require a period of chronic red cell transfusion therapy
- Subject/parental/guardian permission (willing to sign a consent form) and if appropriate, child assent
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
Red 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)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States