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

Not Applicable

Completed

• Conditions: Arrhythmias, Cardiac; Thromboembolism; Healthy; Heart Valves
• Interventions: Device: Self testing INR device

• Registration Number: NCT02779400
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Study Start: 2016-05-23
• Primary Completion: 2018-04-14
• Study Completion: 2018-06-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of the device perfomance	Self testing INR device	-

Primary Outcome Measures

Name	Time	Method
Accuracy of measurement of the INR with the study device	Just after the blood taken at day 1	The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.

Secondary Outcome Measures

Name	Time	Method
Repeatability of measurement of the INR with the study device	Just after the blood taken at day 1	Comparison of 8 INR measurements performed with the device in a range of 15 minutes.
Reproductibility of measurement of the INR with the study device	Just after the blood taken at day 1	Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device

Trial Locations

Locations (1)

Clinical research center of Grenoble university hospital; 🇫🇷 Grenoble, Rhône Alpes, France