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Evaluation of the Clinical Performances of a Point of Care Analyzer Enabling Pre-transfusion ABOD Group Ultimate Verification at the Patient Bedside

NCT04344613 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-10-06

No results posted yet for this study

Summary

ABO-incompatible red blood cell transfusions still represent an important hazard in transfusion medicine. Therefore, some countries have introduced a systematic bedside ABO agglutination test checking that the right blood is given to the right patient. However, this strategy is entirely manual, requires an extremely time-consuming learning program and relies on a subjective interpretation of agglutination on ABO test cards (for example Biorad, Diagast).

The ULB spinoff Antigon developed a prototype device on the basis of a technology developed in the Translational research laboratory of CHU-Brugmann, ULB. This device is specifically dedicated to perform a "near patient" control of the blood group of the patient and of the blood bag just before transfusion, and to control that the right blood bag is given to the right patient by cross-checking their identifications. The principle of the assay relies on an agglutination and filtration in a disk including anti A,B and D antibodies.

The goal of this study is to validate the analytical performances of this device (phase A) and to validate the clinical performances of this device (phase B).

Conditions

  • Blood Transfusion Complication

Interventions

DEVICE

ABODpoct device

The device has been developed by a consortium including the Université Libre de Bruxelles, research centers (SIRRIS, CER), a private company (CISEO), and the spin-off Antigon S.A..The device includes a reader and a disposable disk (ABOD disk) for testing one patient et a blood bag. Four blood drops from the patient are deposited on one side of the disk and 4 blood drops from the blood bag one the other side. The disk correctly filled is inserted in the reader and after 2 minutes the result is displayed on the screen as a message GO or No GO. In case of incompatibility or any other problem a red Stop message will appear on the screen.

Sponsors & Collaborators

  • Francis Corazza

    lead OTHER

Principal Investigators

  • Hanane El Kenz, MD · CHU Brugmann

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Belgium

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 NCT04344613 on ClinicalTrials.gov