RH Genotype Matched RBC Transfusions

  • STATUS
    Recruiting
  • End date
    Jul 21, 2024
  • participants needed
    35
  • sponsor
    Children's Hospital of Philadelphia
Updated on 19 October 2021

Summary

To determine the feasibility of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.

Description

This is a pilot feasibility study in patients with Sickle Cell Disease requiring chronic red cell transfusions. RH genotyped donor units will be obtained from the New York Blood Center. Patients will be matched with donor units whose RH genotypes predict no foreign Rh protein exposure to the patient. This will provide red cell matching at a level above the current standard of care (serologic C, E, and K matching). Patients will receive RH matched red cells for the duration of their chronic transfusion therapy or up to five years, whichever is shorter. It will then be determined whether sufficient RH matched donor units can be identified for the patient's RH genotype. Although not powered to determine effectiveness, all patients's Rh alloantibody formation will be monitored.

For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.

For all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days.

Details
Condition Sickle Cells Disease
Treatment Red cell units that are genotype matched at the RHD and RHCE loci
Clinical Study IdentifierNCT04156893
SponsorChildren's Hospital of Philadelphia
Last Modified on19 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects age >12 months
Diagnosis of SCD, all genotypes
Require a period of chronic red cell transfusion therapy

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
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