RHD Genotype Matching for Anti-D
|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: NCT04156906|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Anti-D Antibodies||Biological: D+ RH genotype matched red cell units for transfusion||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RH Genotype Matched Red Cells for Patients With Sickle Cell Disease and Anti-D|
|Actual Study Start Date :||July 8, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: D+ RH genotype matched Red Blood Cell Transfusion
Investigators will provide one red cell unit of D+ RH genotype matched RBCs at the first transfusion study visit. The remainder of units will be provided per clinical standard of care, i.e. D-, CEK-matched, and negative for all other antigens the patient is alloimmunized against. If laboratory monitoring shows no reappearance of anti-D and no signs of increased red cell hemolysis, the patient will receive one unit of D+ RH genotype matched RBCs at the 2nd transfusion study visit, and if tolerated, D+ red cell exposures will increase by one unit per study visit until all units required are D+.
Biological: D+ RH genotype matched red cell units for transfusion
Chronically transfused patients with SCD and anti-D will receive D+ RH genotyped matched red cell units for transfusion in addition to standard C, E, and K antigen matching and being hemoglobin S negative, which is the Children's Hospital of Philadelphia institutional standard of care for patients with SCD. RH genotyping of donor units will be performed by the New York Blood Center (NYBC) Immunogenetics laboratory.
- Feasibility and safety of providing RH genotype matched D+ RBCs to patients with SCD who type D+ but have formed anti-D [ Time Frame: 5 years ]To determine feasibility of identifying sufficient RH genotype matched units (identifying sufficient RH genotype match red cells without delays in transfusion), and safety (no anti-D reappearance or evidence of hemolysis of transfused red cells).
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): NCT04156906
|Contact: Stacey Uter, BSfirstname.lastname@example.org|
|Contact: Stella Chou, MDemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Stacey Uter, BS 215-590-7722 firstname.lastname@example.org|
|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|