NCT03727230

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

October 26, 2018

Results QC Date

January 12, 2022

Last Update Submit

September 12, 2023

Conditions

Blood TransfusionRhesus Isoimmunisation Due to Anti-DBlood Group Antigen Abnormality

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs

    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.

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

Secondary Outcomes (1)

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

    During the blood transfusion and in the days of hospitalization

Study Arms (1)

Asian-type DEL recipients

EXPERIMENTAL

First, to identify Asian-type DEL patients by phenotyping and genotyping methods in the Chinese recipients having a serologically apparent RhD-negative phenotype. Then, blood transfusion of RhD+ blood rather than rare RhD-negative blood to the Asian-type DEL recipients which met the inclusion criteria.

Other: Blood transfusion

Interventions

Blood transfusionOTHER

Transfusion with RhD+ blood product rather than rare RhD-negative blood to Asian-type DEL recipients

Asian-type DEL recipients

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsEligible participant inclusions were as follows: (1) all male Asian-type DEL patients; (2) female Asian-type DEL patients beyond the gestational age (≥49 years); (3) female Asian-type DEL patients of childbearing age but with severe illness and no plan of further pregnancy
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Guangdong General Hospital

Guangzhou, Guangdong, 510000, China

Location

Guangdong Province Traditional Chinese Medical Hospital

Guangzhou, Guangdong, 510000, China

Location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Guangzhou Blood Center

Guangzhou, Guangdong, 510095, China

Location

Related Publications (1)

  • Ji Y, Luo Y, Wen J, Sun Y, Jia S, Ou C, Yang W, Chen J, Ye H, Liu X, Liang Y, Lu Z, Feng Y, Wu X, Xiao M, Mo J, Zhou Z, Wang Z, Liao Z, Chen J, Wei L, Luo G, Santoso S, Fichou Y, Flegel WA, Shao C, Li C, Zhang R, Fu Y. Patients with Asian-type DEL can safely be transfused with RhD-positive blood. Blood. 2023 Apr 27;141(17):2141-2150. doi: 10.1182/blood.2022018152.

    PMID: 36638337DERIVED

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Limitations and Caveats

A large-scale clinical trial cannot be conducted since Asian-type DEL is rarely distributed in our population, with a frequency of approximately 0.1%. Additionally, a prudent inclusion criterion was adopted in this study to avoid potential alloanti-D immunization and negative influences on pregnancy in women of reproductive age and young girls, in which they were excluded from the trial with great caution.

Results Point of Contact

Title
Director of Clinical Trials
Organization
Guangzhou Blood Center
fuyongshui1969@yahoo.com
+86-20 83595049

Study Officials

  • Yongshui Fu, MD, PhD

    Guangzhou Blood Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single-arm clinical trial of Chinese Asian-type DEL patients receiving RhD+ RBC transfusion was conducted. Although truly RhD-negative patients receiving RhD+ RBC transfusion were recognized as the ideal control group, they were not included in this study because it did not comply with the Chinese Clinical Blood Transfusion Standard and ethics principles. The truly RhD-negative patients could receive RhD+ blood only in emergency situations under conditions of an insufficient stock of RhD-negative RBCs. Thus, the summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis （Vox Sang 2021, http://doi.org/10.1111/vox.13232）was used as the control for comparison.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 1, 2018

Study Start

October 1, 2016

Primary Completion

October 9, 2021

Study Completion

November 30, 2021

Last Updated

March 21, 2024

Results First Posted

March 21, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)