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

Primary Purpose

Healthy, Heart Valves, Arrhythmias, Cardiac

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self testing INR device
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring INR, coagulation, vitamin K antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Clinical research center of Grenoble university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation of the device perfomance

Arm Description

Outcomes

Primary Outcome Measures

Accuracy of measurement of the INR with the study device
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

Repeatability of measurement of the INR with the study device
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
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

Full Information

First Posted
August 27, 2015
Last Updated
October 10, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02779400
Brief Title
Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
Acronym
HEMOPTICS2
Official Title
Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
April 14, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Heart Valves, Arrhythmias, Cardiac, Thromboembolism
Keywords
INR, coagulation, vitamin K antagonist

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of the device perfomance
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Self testing INR device
Other Intervention Name(s)
In vitro diagnostic device measuring INR
Intervention Description
the procedure involves a series of repeated measurements of INR with the studied device
Primary Outcome Measure Information:
Title
Accuracy of measurement of the INR with the study device
Description
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.
Time Frame
Just after the blood taken at day 1
Secondary Outcome Measure Information:
Title
Repeatability of measurement of the INR with the study device
Description
Comparison of 8 INR measurements performed with the device in a range of 15 minutes.
Time Frame
Just after the blood taken at day 1
Title
Reproductibility of measurement of the INR with the study device
Description
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
Time Frame
Just after the blood taken at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical research center of Grenoble university hospital
City
Grenoble
State/Province
Rhône Alpes
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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