RhD+ Blood Transfusion to Asian-type DEL Recipients

NCT03727230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-21

Study results available
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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.

Conditions

  • Blood Transfusion
  • Rhesus Isoimmunisation Due to Anti-D
  • Blood Group Antigen Abnormality

Interventions

OTHER

Blood transfusion

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

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER
  • Southern Medical University, China

    collaborator OTHER
  • Guangdong Provincial People's Hospital

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Zhujiang Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    collaborator OTHER
  • Guangdong Second Provincial General Hospital

    collaborator OTHER
  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Guangdong Provincial Institute of Biological Products And Materia Medica

    collaborator OTHER
  • Shenzhen Second People's Hospital

    collaborator OTHER
  • Koo Foundation Sun Yat-Sen Cancer Center

    collaborator OTHER
  • Guangzhou Blood Center

    lead OTHER_GOV

Principal Investigators

  • Yongshui Fu, MD, PhD · Guangzhou Blood Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2021-10-09
Completion
2021-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727230 on ClinicalTrials.gov