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RH Genotype Matched RBC Transfusions (RBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156893
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : August 11, 2022
Sponsor:
Collaborators:
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
To determine the feasibility of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Subjects age >12 months
  • Diagnosis of SCD, all genotypes
  • Require a period of chronic red cell transfusion therapy

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Stella Chou, MD 215-590-0947 chous@chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stella Chou, MD    215-590-0947    chous@chop.edu   
Principal Investigator: Stella Chou, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Stella Chou, MD Children's Hospital of Philadelphia
More Information
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Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04156893    
Other Study ID Numbers: 19-016565
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

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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
Keywords provided by Children's Hospital of Philadelphia:
Chronic Transfusion
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn