Trial Outcomes & Findings for RhD+ Blood Transfusion to Asian-type DEL Recipients (NCT NCT03727230)

Last Updated: 2024-03-21

Results Overview

For the Chinese Asian-type DEL recipients identified by the serological adsorption/elution test and HRM genotyping analysis, RhD+ RBC transfusion was performed. Then, the new blood samples from the patients were obtained after transfusion of RhD+ RBCs. The clinical significant alloantibodies against the common antigens of RBC were re-tested by antibody screening test. And the antibody screening test was performed using ID-DiaCell I-II-III Asia Kit (BIO-RAD, Cressier, Switzerland) in saline by the tube method and an indirect antiglobulin test (IAT) with the DG Gel Coombs card (Diagnostic Grifols, Barcelona, Spain). Meanwhile, RhCE and Asian- type DEL typing were also tested again.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion

Results posted on

2024-03-21

Participant Flow

Recruitment ranged between October 2016 and November 2021 in all hospitals located in Guangzhou of China.

The enrolled participants are the Asian-type DEL patients with application for RBCs product from Guangzhou Blood Center, which is the only institute responsible for blood supply in Guangzhou city of China. Guangzhou is the capital city of Guangdong province in South China, with 15 million inhabitants. When any enrolled participants did not receive any blood transfusion finally, because of no need of blood transfusion in the clinic, they were excluded from the study.

Participant milestones

Participant milestones
Measure	Asian-type DEL Recipients Asian-type DEL patients was identified by phenotyping and genotyping methods, then D+ RBCs rather than rare D-negative RBCs were transfused to the "Aisa type" DEL recipients.
Overall Study STARTED	54
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Asian-type DEL Recipients Asian-type DEL patients was identified by phenotyping and genotyping methods, then D+ RBCs rather than rare D-negative RBCs were transfused to the "Aisa type" DEL recipients.
Overall Study Lost to Follow-up	12

Baseline Characteristics

RhD+ Blood Transfusion to Asian-type DEL Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asian-type DEL Recipients n=54 Participants After identification of Asian-type DEL patients by phenotyping and genotyping methods, then D+ RBCs rather than rare D-negative RBCs were transfused to the Aisa-type DEL recipients who met the inclusion criteria. Blood transfusion: Transfusion with D+ blood rather than the rare D-negative blood to Asian-type DEL recipients
Age, Continuous	54.6 years STANDARD_DEVIATION 21.5 • n=99 Participants
Sex: Female, Male Female	20 Participants n=99 Participants
Sex: Female, Male Male	34 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	54 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment China	54 Participants n=99 Participants
Asian-type DEL patients received D+ RBC transfusion	54 Participants n=99 Participants

PRIMARY outcome

Timeframe: A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion

Outcome measures

Outcome measures
Measure	Asian-type DEL Recipients n=54 Participants After identification of Asian-type DEL patients by phenotyping and genotyping methods, then D+ RBCs rather than rare D-negative RBCs were transfused to the Aisan-type DEL recipients. Blood transfusion: Transfusion with D+ blood rather than the rare D-negative blood to Asian-type DEL recipients
Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs No occurrence of alloanti-D immunization	42 Participants
Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs Lost of follow-up	12 Participants

SECONDARY outcome

Timeframe: During the blood transfusion and in the days of hospitalization

Matched D+ RBCs were provided to the 54 eligible Asian-type DEL patients by the Guangzhou Blood Center and transfused at their respective hospitals. Patients were monitored for any adverse events during transfusion and a few days thereafter, which mainly involved acute nor delayed hemolytic transfusion reactions, as well as nonhemolytic reactions, including allergic and febrile nonhemolytic reactions and circulatory overload during or after transfusion. If the symptoms of hemolysis were suspected, the laboratory biochemical measurements were also performed.

Outcome measures

Outcome measures
Measure	Asian-type DEL Recipients n=54 Participants After identification of Asian-type DEL patients by phenotyping and genotyping methods, then D+ RBCs rather than rare D-negative RBCs were transfused to the Aisan-type DEL recipients. Blood transfusion: Transfusion with D+ blood rather than the rare D-negative blood to Asian-type DEL recipients
Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion Without adverse transfusion reaction	54 Participants
Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion With adverse transfusion reaction	0 Participants

Adverse Events

Asian-type DEL Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Asian-type DEL Recipients n=54 participants at risk To identify Asian-type DEL patients by phenotyping and genotyping methods in the Chinese recipients and then blood transfusion of RhD+ blood rather than rare RhD-negative blood to the Aisan-type DEL recipients who met the inclusion criteria. Blood transfusion: Transfusion with RhD+ blood rather than rare RhD-negative blood to Asian-type DEL recipients
General disorders Adverse blood transfusion reactions	0.00% 0/54 • Assessed up to 1354 days following transfusion, a median of 226 days In the condition of correct blood group typing and cross-matching before transfusion, and carefully checking and monitoring during the transfusion, the transfusion treatment is quite safe with very low frequency of serious adverse event and mortality.

Additional Information

Director of Clinical Trials

Guangzhou Blood Center

Phone: +86-20 83595049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place