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

NCT04344613 | Withdrawn

• 1 other identifier: LRT-ABOD- PICABO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Cut off value of optical signal - antigen A

  Determination of the analytical performances of each channel of the disk:analysis of discrimination between positive and negative samples for each blood group antigen.

  6 months

• Cut off value of optical signal - antigen B

  Determination of the analytical performances of each channel of the disk:analysis of discrimination between positive and negative samples for each blood group antigen.

  6 months

• Cut off value of optical signal - antigen D

  Determination of the analytical performances of each channel of the disk:analysis of discrimination between positive and negative samples for each blood group antigen.

  6 months

• Cut off value of optical signal - negative control

  Determination of the analytical performances of each channel of the disk:analysis of discrimination between positive and negative samples for each blood group antigen.

  6 months

• Percentage of concordance of the blood group

  Percentage of concordance between the blood group result delivered by the tested device and the blood group determined by the validated laboratory methods.

  6 months

Study Arms (1)

Blood samples

EXPERIMENTAL

Device: ABODpoct device

Interventions

ABODpoct device 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.

Blood samples

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For the device evaluation inside the laboratory : every patient for whom a blood group is ordered to the blood transfusion laboratory.
• For the device bedside evaluation : each patient from the hematology unit (one day clinic) requiring a transfusion.

You may not qualify if:

• Emergency circumstances requiring an urgent transfusion
• Patient older than 80 years old
• Patients with venous access

Sponsors & Collaborators

• Francis Corazza: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Hanane El Kenz, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Immunology Laboratory

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: April 14, 2020
• Study Start: April 10, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)