drugset / Trial / NCT04156906
RHD Genotype Matched Red Cells for Anti-D
Phase 0
Completed
5 enrolled
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI) · collabNew York Blood Center · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a pilot study to evaluate the feasibility and safety of providing RH genotype matched D+ Red Blood Cells (RBCs) to chronically transfused patients with sickle cell disease (SCD) who type D+ but have formed anti-D and are currently transfused with D- RBC (Red Blood Cell) units.
Timeline
- Start
- 2020-07-08
- Primary completion
- 2024-03-04
- Completion
- 2024-10-04
Publications
- Background Chou ST, Jackson T, Vege S, Smith-Whitley K, Friedman DF, Westhoff CM. High prevalence of red blood cell alloimmunization in sickle cell disease despite transfusion from Rh-matched minority donors. Blood. 2013 Aug 8;122(6):1062-71. doi: 10.1182/blood-2013-03-490623. Epub 2013 May 30.
- Background 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.
- Background 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.
- Background Chou ST, Evans P, Vege S, Coleman SL, Friedman DF, Keller M, Westhoff CM. RH genotype matching for transfusion support in sickle cell disease. Blood. 2018 Sep 13;132(11):1198-1207. doi: 10.1182/blood-2018-05-851360. Epub 2018 Jul 19.
- Background Dezan MR, Ribeiro IH, Oliveira VB, Vieira JB, Gomes FC, Franco LAM, Varuzza L, Ribeiro R, Chinoca KZ, Levi JE, Krieger JE, Pereira AC, Gualandro SFM, Rocha VG, Mendrone-Junior A, Sabino EC, Dinardo CL. RHD and RHCE genotyping by next-generation sequencing is an effective strategy to identify molecular variants within sickle cell disease patients. Blood Cells Mol Dis. 2017 Jun;65:8-15. doi: 10.1016/j.bcmd.2017.03.014. Epub 2017 Mar 31.
- Mewha J, Vege S, Friedman DF, Makrm S, Ochoa G, Westhoff CM, Chou ST. Red cell antigen exposures in patients with sickle cell disease receiving transfusion from Black and Hispanic donors. Blood Red Cells Iron. 2026 Jun;2(2):100059. doi: 10.1016/j.brci.2026.100059. Epub 2026 Apr 8.
- Chou ST, Mewha J, Friedman DF, Lazariu V, Makrm S, Ochoa G, Vege S, Westhoff CM. Genotyped RhD+ red cells for D-positive patients with sickle cell disease with conventional RHD and unexpected anti-D. Blood. 2024 Nov 7;144(19):2045-2049. doi: 10.1182/blood.2024025602.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D+ RH genotype matched red cell units for transfusion | Unknown | — | Other |