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RH Genotype Matched RBC Transfusions

ConditionSickle Cells Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorChildren's Hospital of Philadelphia

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Red cell units that are genotype matched at the RHD and RHCE loci

    Biological/Vaccine

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: RH genotype matched red cell transfusionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the treatment efficacy by monitoring the rate of Rh alloimmunization

A primary objective is to determine whether providing RH genotype matched red cell units can reduce or prevent Rh alloimmunization.

Time frame
3.5 years
2

Determine the feasibility of identifying sufficient RH genotype matched units

A primary objective is to determine the feasibility of identifying sufficient RH genotype matched red cells for chronically transfused patients with SCD with varied RH genotypes. Approximately 20 RHD (Rhesus D) and 20 RHCE (Rhesus CE) variants have been observed in patients with SCD and will determine whether sufficient RH genotyped units can be matched to the patient's own RH genotype.

Time frame
3.5 years

Secondary outcomes

1

Determine the rate of non-Rh alloimmunization

A secondary objective is to determine the rate of antibody formation outside the Rh blood group system, such as anti-Kidd or -S/s.

Time frame
3.5 years

Other outcomes

Sponsors and contacts

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Children's Hospital of Philadelphia

Lead sponsor

New York Blood Center

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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