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Blood Transfusion

RH Genotype Matched RBC Transfusions for Sickle Cell Disease (RBC Trial)

Phase 1 & 2

Recruiting

Led By Stella Chou, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Require a period of chronic red cell transfusion therapy

Diagnosis of SCD, all genotypes

Must not have

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

Rare RH genotype that would preclude identification of sufficient RBC units

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether it's possible to match donor red cells by RH genotype for patients with SCD who regularly need transfusions.

Who is the study for?

This trial is for individuals over 1 year old with Sickle Cell Disease who need regular blood transfusions. It's not suitable for those with rare RH genotypes, specific antigen negative requirements due to previous immune reactions, or if matching would expose them to antigens against standard care.

What is being tested?

The study tests the feasibility of using red blood cells that are matched at the RHD and RHCE genes in patients with Sickle Cell Disease receiving chronic transfusion therapy.

What are the potential side effects?

While specific side effects aren't listed, typical risks may include allergic reactions to transfused blood, iron overload from frequent transfusions, and potential complications from mismatched blood types.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need long-term blood transfusions.

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I have been diagnosed with sickle cell disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive certain blood types due to my body's previous reactions.

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My blood type is very rare, making it hard to find matching blood for transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the feasibility of identifying sufficient RH genotype matched units

Determine the treatment efficacy by monitoring the rate of Rh alloimmunization

Secondary study objectives

Determine the rate of non-Rh alloimmunization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RH genotype matched red cell transfusionsExperimental Treatment1 Intervention

Subjects will receive RH genotyped matched red cell units for transfusion in addition to standard serologic C, E, and K antigen matching and being hemoglobin S negative, which is our institutional standard of care for patients with Sickle Cell Disease.

0 / 4Eligibility criteria met