NCT03727230

RhD+ Blood Transfusion to Asian-type DEL Recipients

Completed NA Results posted Last updated 21 March 2024

What this trial tests

NA trial testing Blood transfusion in Blood Transfusion in 54 participants. Completed in 30 November 2021.

Timeline

1 October 2016

Primary endpoint
9 October 2021

30 November 2021

Quick facts

Lead sponsor	Guangzhou Blood Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 October 2016
Primary completion	9 October 2021
Estimated completion	30 November 2021
Sites	10 locations across China

Drugs / interventions tested

• Blood transfusion — full drug profile →

Conditions studied

• Blood Transfusion — all drugs for Blood Transfusion →
• Rhesus Isoimmunisation Due to Anti-D — all drugs for Rhesus Isoimmunisation Due to Anti-D →
• Blood Group Antigen Abnormality — all drugs for Blood Group Antigen Abnormality →

Sponsor

Guangzhou Blood Center — full company profile →

Who can join

Eligibility, any sex, with Blood Transfusion or Rhesus Isoimmunisation Due to Anti-D. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs Primary · A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion

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 Grifol

Group	Value	95% CI
Asian-type DEL Recipients	42
Asian-type DEL Recipients	12

Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion Secondary · 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.

Group	Value	95% CI
Asian-type DEL Recipients	54
Asian-type DEL Recipients	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Assessed up to 1354 days following transfusion, a median of 226 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Asian-type DEL Recipients

Serious: 0/54 (0%)

Deaths: 7/54

Other adverse events (1 terms — click to expand)

Reaction	System	Asian-type DEL Recipients
Adverse blood transfusion reactions	General disorders	—

Data from ClinicalTrials.gov NCT03727230 adverse events section.

Sponsor's own description

Red blood cells (RBCs) from Asian-type DEL blood group express very weak RhD antigen and are falsely typed as RhD-negative blood group in routine RhD testing. Until now, Asian-type DEL (D-eluate) patients still be treated as rare RhD-negative patients in the clinic. Previous study from the Asian-type DEL pregnant women with RhD+ fetus showed no occurrence of alloanti-D immunization. This result, however, does not directly be applied for Asian-type DEL patients receiving RhD+ blood transfusions, as lacking of direct evidence regarding the safety and underlying mechanism.

In this study, the patients with Asian-type DEL were identified and received RhD+ blood transfusion, then evaluations of any adverse reactions, especially the active follow-up alloantibody test, were prospectively conducted.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patients with Asian-type DEL can safely be transfused with RhD-positive blood.
   Ji Y, Luo Y, Wen J, Sun Y, et al · · 2023 · cited 24× · PMID 36638337 · DOI 10.1182/blood.2022018152