Trial Outcomes & Findings for RHD Genotype Matched Red Cells for Anti-D (NCT NCT04156906)

NCT ID: NCT04156906

Last Updated: 2025-05-02

Results Overview

To determine safety of providing RH genotype match red cells to patients with a history of anti-D, we observed if anti-D reappearance occurred or evidence of hemolysis of transfused red cells.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: Through study completion and follow-up phase, an average of 10 months per participant
• Results posted on: 2025-05-02

Participant Flow

Participant milestones

Measure	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+. 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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RHD Genotype Matched Red Cells for Anti-D

Baseline characteristics by cohort

Measure	D+ RH Genotype Matched Red Blood Cell Transfusion n=5 Participants 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+. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion and follow-up phase, an average of 10 months per participant

Population: All participants completed all study requirements with no reappearance of anti-D.

To determine safety of providing RH genotype match red cells to patients with a history of anti-D, we observed if anti-D reappearance occurred or evidence of hemolysis of transfused red cells.

Outcome measures

Measure	D+ RH Genotype Matched Red Blood Cell Transfusion n=5 Participants 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+. 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.
Anti-D Recurrence Anti-D recurrence	0 Participants
Anti-D Recurrence No anti-D recurrence	5 Participants

Adverse Events

D+ RH Genotype Matched Red Blood Cell Transfusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stella Chou, MD

The Children's Hospital of Philadelphia

Phone: 215-590-0947

Email: chous@chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place