Arrhythmias, Cardiac, Healthy, Heart Valves, Thromboembolism
Conditions
Keywords
INR, coagulation, vitamin K antagonist
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.
Interventions
DEVICESelf testing INR device
the procedure involves a series of repeated measurements of INR with the studied device
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed