N/A
N=54
RhD+ Blood Transfusion to Asian-type DEL Recipients
Blood Transfusion · Rhesus Isoimmunisation Due to Anti-D · Blood Group Antigen Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT03727230 ↗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
| Outcome | Result | p-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.
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.