Study 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.
Eligible Conditions
- Sickle Cell Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 5.5 years
5.5 years
Determine the occurrence of Rh alloimmunization
Feasibility of identifying sufficient RH genotype matched units
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
RH genotype matched red cell transfusions
1 of 1
Experimental Treatment
35 Total Participants · 1 Treatment Group
Primary Treatment: Red cell units that are genotype matched at the RHD and RHCE loci · No Placebo Group · Phase < 1
RH genotype matched red cell transfusions
Biological
Experimental Group · 1 Intervention: Red cell units that are genotype matched at the RHD and RHCE loci · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5.5 years
Who is running the clinical trial?
New York Blood CenterOTHER
23 Previous Clinical Trials
26,706 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,598 Previous Clinical Trials
46,956,399 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
651 Previous Clinical Trials
7,849,922 Total Patients Enrolled
Stella Chou, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
20 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The diagnosis of SCD is confirmed by the detection of the HbS gene
In order to require a period of chronic red cell transfusion therapy, your doctor will need to determine if you have anemia
You are 12 months of age or older.
References
- 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.
- 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.
- 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.
- 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.
- Coleman, Sarita, Connie M. Westhoff, David F. Friedman, and Stella T. Chou. 2019. “Alloimmunization in Patients with Sickle Cell Disease and Underrecognition of Accompanying Delayed Hemolytic Transfusion Reactions”. Transfusion. Wiley. doi:10.1111/trf.15328.
- Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517. Erratum In: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729.
- Vichinsky EP, Earles A, Johnson RA, Hoag MS, Williams A, Lubin B. Alloimmunization in sickle cell anemia and transfusion of racially unmatched blood. N Engl J Med. 1990 Jun 7;322(23):1617-21. doi: 10.1056/NEJM199006073222301.
- 2020. "RH Genotype Matched RBC Transfusions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04156893.
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Conditions
Cancer Related
Treatments