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Blood Product

Genotype-Matched Blood Transfusion for Sickle Cell Disease

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

Diagnosis of SCD, all genotypes

Subjects age > 8 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether it is safe to give patients with sickle cell disease who have the D+ blood type and have formed antibodies against D blood cells, D+ blood cells instead of the D- blood cells they currently receive during transfusions.

Who is the study for?

This trial is for people over 8 years old with sickle cell disease who need regular blood transfusions and have developed anti-D antibodies. They must have an RH genotype that suggests D+ expression. Those with rare RH genotypes or other immune responses preventing enough safe RBC units are excluded.Check my eligibility

What is being tested?

The study tests the safety of giving chronically transfused sickle cell patients, who are D+ and have anti-D antibodies, red blood cells matched to their RH genotype instead of the usual D- units they receive.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include reactions to mismatched blood such as fever, chills, or more serious complications like hemolytic transfusion reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with sickle cell disease.

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I am older than 8 years.

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I need regular blood transfusions to manage my condition.

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My RH genotype indicates D+ expression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 and safety of providing RH genotype matched D+ RBCs to patients with SCD who type D+ but have formed anti-D

Trial Design

1Treatment groups

Experimental Treatment

Group I: D+ RH genotype matched Red Blood Cell TransfusionExperimental Treatment1 Intervention

Investigators will provide one red cell unit of D+ RH genotype matched RBCs at the first transfusion study visit. The remainder of units will be provided per clinical standard of care, i.e. D-, CEK-matched, and negative for all other antigens the patient is alloimmunized against. If laboratory monitoring shows no reappearance of anti-D and no signs of increased red cell hemolysis, the patient will receive one unit of D+ RH genotype matched RBCs at the 2nd transfusion study visit, and if tolerated, D+ red cell exposures will increase by one unit per study visit until all units required are D+.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,255 Total Patients Enrolled

New York Blood CenterOTHER

23 Previous Clinical Trials

26,674 Total Patients Enrolled

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

3,836 Previous Clinical Trials

47,311,092 Total Patients Enrolled

Media Library

D+ RH genotype matched red cell units (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT04156906 — Phase < 1

Sickle Cell Disease Research Study Groups: D+ RH genotype matched Red Blood Cell Transfusion

Sickle Cell Disease Clinical Trial 2023: D+ RH genotype matched red cell units Highlights & Side Effects. Trial Name: NCT04156906 — Phase < 1

D+ RH genotype matched red cell units (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04156906 — Phase < 1

Frequently Asked Questions

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

What is the enrollment rate for this clinical investigation?

"Affirmative. Information presented on clinicaltrials.gov confirms that this medical trial, which began recruitment on July 8th 2020, is still actively searching for participants. Only 20 patients need to be found from one medical centre."

Answered by AI

Is this study actively seeking participants?

"This is accurate. According to information given on clinicaltrials.gov, the trial initiated registration on July 8th 2020 and was updated most recently on August 10th 2022; currently recruiting 20 participants from one medical centre."

Answered by AI

Recent research and studies

BloodJournal

High Prevalence of Red Blood Cell Alloimmunization in Sickle Cell Disease Despite Transfusion from Rh-matched Minority Donors

Chou, Stella T., Tannoa Jackson, Sunitha Vege, Kim Smith-Whitley, David F. Friedman, and Connie M. Westhoff. 2013. “High Prevalence of Red Blood Cell Alloimmunization in Sickle Cell Disease Despite Transfusion from Rh-matched Minority Donors”. Blood. American Society of Hematology. doi:10.1182/blood-2013-03-490623.

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