Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement (HEMOPTICS2)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Thromboembolism; Healthy; Arrhythmias, Cardiac; Heart Valves

Treatments: Device: Self testing INR device

Study type: Interventional

Funder types: Other

Identifiers

NCT02779400

DCIC/14/54

Details and patient eligibility

About

The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

Full description

The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.

The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.

The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.

A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients treated with vitamin K agonist or healthy volunteers
• For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
• No acute disease in the previous month

Exclusion criteria

• Pregnant woman

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Evaluation of the device perfomance

Experimental group

Treatment:

Device: Self testing INR device