Mode
Text Size
Log in / Sign up
N/A N=54 Treatment

RhD+ Blood Transfusion to Asian-type DEL Recipients

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

Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs — 42; 12 Participants — p=< 0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Blood transfusion (Other)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Guangzhou Blood Center
Primary completion
Oct 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs
42; 12 < 0.001 sig
SECONDARY
Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion
54; 0

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.

Eligibility Criteria

Inclusion criteria for eligible participants were as follows: (1) Asian-type DEL blood group; (2) male patients, or female patients ≥ 49 years of age, or female with severe illness and no plan for further pregnancy; (3) needing blood transfusion in line with guidelines for internal medicine or surgery; and (4) signed voluntary informed consent for blood transfusion treatment before the trial. The exclusion criteria were: (1) adverse reaction in a previous transfusion; (2) allergies to blood products or immunodeficiency diseases; (3) needing massive blood transfusion for acute blood loss; (4) positive pregnancy test results; (5) conscious dysfunction or severe mental illness; and (6) unsuitability for the study, as estimated by the principal investigators.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03727230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search