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ABTEST© Card Clinical Perfomance Study

NCT ID: NCT05140395

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2021-11-04

Brief Summary

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The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

Detailed Description

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The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .

Conditions

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Transfusion Reaction

Keywords

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Reagent Kits, Diagnostic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

in situ used for near patient In vitro Medical device
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pre transfusion control

Pre control transfusion with the referent reagent and the in study reagent

Group Type EXPERIMENTAL

ABTEST card

Intervention Type DIAGNOSTIC_TEST

Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card

Interventions

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ABTEST card

Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.

10 neonatal patients, background transfusion or Guthrie test.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diagast

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Huchette, phD

Role: PRINCIPAL_INVESTIGATOR

CH Arras

Locations

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CH Arras

Arras, , France

Site Status

Countries

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France

Other Identifiers

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CPSP_20-01_V1

Identifier Type: -

Identifier Source: org_study_id