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.
- Sickle Cell Disease
- Anti-D Antibodies
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 5 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
D+ RH genotype matched Red Blood Cell Transfusion
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: D+ RH genotype matched red cell units for transfusion · No Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- Dezan, Marcia R., Ingrid Helena Ribeiro, Valéria B. Oliveira, Juliana B. Vieira, Francisco C. Gomes, Lucas A.M. Franco, Leonardo Varuzza, et al.. 2017. “RHD and RHCE Genotyping by Next-generation Sequencing Is an Effective Strategy to Identify Molecular Variants Within Sickle Cell Disease Patients”. Blood Cells, Molecules, and Diseases. Elsevier BV. doi:10.1016/j.bcmd.2017.03.014.
- 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.
- 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.
- 2020. "RHD Genotype Matching for Anti-D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04156906.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor