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Completed

NCT Number: NCT02779400

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

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

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Key information

Conditions

Healthy Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Heart Valves Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical research center of Grenoble university hospital

Grenoble, Auvergne-Rhône-Alpes, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self testing INR device

Device

the procedure involves a series of repeated measurements of INR with the studied device

Other names: In vitro diagnostic device measuring INR

Primary outcomes

  1. Accuracy of measurement of the INR with the study device

    Time frame: 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 outcomes

  1. Repeatability of measurement of the INR with the study device

    Time frame: Just after the blood taken at day 1

    Comparison of 8 INR measurements performed with the device in a range of 15 minutes.

  2. Reproductibility of measurement of the INR with the study device

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: HEMOPTICS2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 20, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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