RH Genotype Matched RBC Transfusions (RBC)
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|ClinicalTrials.gov Identifier: NCT04156893|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : August 11, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cells Disease||Biological: Red cell units that are genotype matched at the RHD and RHCE loci||Early Phase 1|
This is a pilot feasibility study in patients with Sickle Cell Disease requiring chronic red cell transfusions. RH genotyped donor units will be obtained from the New York Blood Center. Patients will be matched with donor units whose RH genotypes predict no foreign Rh protein exposure to the patient. This will provide red cell matching at a level above the current standard of care (serologic C, E, and K matching). Patients will receive RH matched red cells for the duration of their chronic transfusion therapy or up to five years, whichever is shorter. It will then be determined whether sufficient RH matched donor units can be identified for the patient's RH genotype. Although not powered to determine effectiveness, all patients's Rh alloantibody formation will be monitored.
For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.
For all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Subjects will receive RH genotype matched red cell units for transfusion. For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.
For all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days
|Masking:||None (Open Label)|
|Official Title:||RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease|
|Actual Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: RH genotype matched red cell transfusions
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.
Biological: Red cell units that are genotype matched at the RHD and RHCE loci
Patients will be provided with red cell units that are C, E, and K antigen matched (standard of care for patients with SCD) and genotype matched at the RHD and RHCE loci.
- Feasibility of identifying sufficient RH genotype matched units [ Time Frame: 5.5 years ]The primary objective of this study is to determine the feasibility of RH genotype matched red cells for chronically transfused patients with SCD. Approximately 20 RHD (Rhesus D) and 20 RHCE (Rhesus CE) variants have been observed in patients with SCD, and will determine whether sufficient RH genotyped units can be matched to the patient's own RH genotype.
- Determine the occurrence of Rh alloimmunization [ Time Frame: 5.5 years ]The secondary objective is to determine if there is a relationship between providing RH genotype matched red cell units to Rh alloimmunization. Although not powered to determine effectiveness, our secondary objective is to monitor for Rh alloimmunization.
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|Ages Eligible for Study:||1 Year and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects age >12 months
- Diagnosis of SCD, all genotypes
- Require a period of chronic red cell transfusion therapy
- Rare RH genotype that would preclude identification of sufficient RBC units
- Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units
- Alloimmunized to D antigen
- Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156893
|Contact: Stella Chou, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Stella Chou, MD 215-590-0947 email@example.com|
|Principal Investigator: Stella Chou, MD|
|Principal Investigator:||Stella Chou, MD||Children's Hospital of Philadelphia|
|Responsible Party:||Children's Hospital of Philadelphia|
|Other Study ID Numbers:||
R01HL147879-01 ( U.S. NIH Grant/Contract )
|First Posted:||November 8, 2019 Key Record Dates|
|Last Update Posted:||August 11, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn