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

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).

Study Overview

• Status: Recruiting
• Conditions: Blood Transfusion Complication
• Intervention / Treatment: Device: ABODpoct device

Detailed Description

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.

Results of a preliminary study using a first Proof of Concept Prototype demonstrated the feasibility of ABO determination with a simple device, eliminating manipulation and subjective interpretation responsible for transfusion errors.The investigators then developed an end-user friendly, portable device using disposable fluidic disks and including everything needed to perform an agglutination test to determine the ABO group + RHD status of a patient and a blood bag, or alternatively of two patients.The system is designed to be used near the patient just before the beginning of transfusion.

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).

Phase A will be conducted in the laboratory and will allow the determination of the cut off values for the quantitative optical measures. These cut-off values will define the presence or absence of antigens A, B or D. Blood groups will be determined using the prototype and compared to the blood group determined in the blood transfusion laboratory with an automate using gel filtration technology. The validation will be performed both on blood bag samples and on random EDTA blood samples collected from consecutive unselected patients of our institution for whom a blood group had been requested (no additional sampling procedure nor additional blood volume will be required). The performances of the defined cut-off values will be tested in a second step on additional blood pathological samples selected from the routine samples received at the laboratory. They will cover a large range of hematological and immunological anomalies susceptible to interfere with or impair test performance and results. Finally, tests will be run on residual blood samples of neonates.

Phase B will be conducted to investigate the performances of the device in real conditions for the ultimate control of the ABO compatibility by comparing the patient and blood bag ABO groups. It will be conducted for its most part inside the laboratory and for another part in clinical units where the test will be performed by the nurses, with the assistance of the technologist involved in the validation of the device. For the part of the study conducted inside the lab, blood bags routinely attributed to patients will be selected the be tested on the device in parallel with the blood from the correct patient or from a 'wrong' (with other blood group) patient, in order to simulate situations of transfusion errors and evaluate the performances of the device to identify and block these errors. If the results are satisfying, the device will be tested in real life at the bedside in real conditions of transfusion. For this part of validation the results provided by the device (expressed as Compatible/not compatible/undetermined) will be compared with the results obtained with the manual point of care compatibility control (according to local procedure), and with the known groups of the patient and the blood bag stored in the patient blood bank file.

The number of ABO tests both on patients and on blood bag from donors has been determined in accordance with the recommendations from European Commission for Technical Specifications for In vitro diagnostic medical devices. ABOD assay performances have to be evaluated on at least 3000 samples.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis Corazza, MD; Phone Number: 32 2 4772506; Email: francis.corazza@chu-brugmann.be
• Study Contact Backup: Name: Hanane El Kenz, MD; Phone Number: 32 2 477 27 34; Email: Hanane.ELKENZ@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: Francis Corazza, MD; Phone Number: 32 2 477 25 06; Email: francis.corazza@chu-brugmann.be
    • Principal Investigator: Hanane El Kenz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blood samples

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Francis Corazza
• Investigators: Principal Investigator: Hanane El Kenz, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: LRT-ABOD- PICABO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No