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Blood Transfusion

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

Q: Is the recruitment phase of this clinical trial currently underway?

<p>The clinical trial is still recruiting, as confirmed by its listing on the clinicaltrials.gov website. This particular medical research project was initiated on January 30th 2020 and has been revised most recently on August 10th 2022.</p>

Q: What is the current enrollment capacity for this medical research endeavor?

<p>Affirmative. The clinicaltrial.gov listing for this research program indicates that it is actively recruiting participants, with 35 total enrollees across 1 site needed since its initiation on the 30th of January 2020 and most recent update on August 10th 2022.</p>

Phase < 1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.5 years

Awards & highlights

RBC Trial 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.Check my eligibility

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.See study design

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.

RBC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I need long-term blood transfusions.

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I have been diagnosed with sickle cell disease.

RBC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of identifying sufficient RH genotype matched units

Secondary outcome measures

Determine the occurrence of Rh alloimmunization

RBC 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,268 Total Patients Enrolled

New York Blood CenterOTHER

23 Previous Clinical Trials

26,659 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,635 Total Patients Enrolled

Media Library

Red cell units that are genotype matched at the RHD and RHCE loci (Blood Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT04156893 — Phase < 1

Sickle Cell Disease Research Study Groups: RH genotype matched red cell transfusions

Sickle Cell Disease Clinical Trial 2023: Red cell units that are genotype matched at the RHD and RHCE loci Highlights & Side Effects. Trial Name: NCT04156893 — Phase < 1

Red cell units that are genotype matched at the RHD and RHCE loci (Blood Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04156893 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this clinical trial currently underway?

"The clinical trial is still recruiting, as confirmed by its listing on the clinicaltrials.gov website. This particular medical research project was initiated on January 30th 2020 and has been revised most recently on August 10th 2022."

Answered by AI

What is the current enrollment capacity for this medical research endeavor?

"Affirmative. The clinicaltrial.gov listing for this research program indicates that it is actively recruiting participants, with 35 total enrollees across 1 site needed since its initiation on the 30th of January 2020 and most recent update on August 10th 2022."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Alloimmunization in Sickle Cell Anemia and Transfusion of Racially Unmatched Blood

Vichinsky, Elliott P., Ann Earles, Robert A. Johnson, M. Silvija Hoag, Amber Williams, and Bertram Lubin. 1990. “Alloimmunization in Sickle Cell Anemia and Transfusion of Racially Unmatched Blood”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199006073222301.

JamaJournal

Management of Sickle Cell Disease

Yawn, Barbara P., George R. Buchanan, Araba N. Afenyi-Annan, Samir K. Ballas, Kathryn L. Hassell, Andra H. James, Lanetta Jordan, et al.. 2014. “Management of Sickle Cell Disease”. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.10517.

BloodJournal

RH Genotype Matching for Transfusion Support in Sickle Cell Disease

Chou, Stella T., Perry Evans, Sunitha Vege, Sarita L. Coleman, David F. Friedman, Margaret Keller, and Connie M. Westhoff. 2018. “RH Genotype Matching for Transfusion Support in Sickle Cell Disease”. Blood. American Society of Hematology. doi:10.1182/blood-2018-05-851360.

BloodJournal