Validation of a Portable Medical Device for Diagnostic in Vitro (HEMOPTIC)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Patients Under Vitamin K Antagonist (VKA); Healthy Volunteer

Treatments: Device: HEMOPTIC

Study type: Interventional

Funder types: Other

Identifiers

NCT02843958

38RC14.008

Details and patient eligibility

About

This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria of healthy volunteers:

• Man or woman between 18 and 70 years
• Body Mass Index >18 and <29
• Absence of any acute pathology in the month preceding the study
• To be affiliated or beneficiary of social security

Exclusion Criteria of healthy volunteers:

• Pregnant, partutient or breastfeeding woman
• Patient with Raynaud's syndrome
• Person deprived of liberty by legal or administrative decision, person to a legal protection order
• Deferral periods for other clinical studies
• Annual threshold compensation attain for biomedical search participations

Inclusion Criteria of patients:

• Man or woman between 18 and 80 years
• Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
• Absence of any acute pathology in the month preceding the study
• To be affiliated or beneficiary of social security

Exclusion Criteria of healthy patients:

• Pregnant, partutient or breastfeeding woman
• Patient with Raynaud's syndrome
• Person deprived of liberty by legal or administrative decision, person to a legal protection order
• Deferral periods for other clinical studies
• Annual threshold compensation attain for biomedical search participations

Trial design

40 participants in 1 patient group

Healthy volunteers and patients under Vitamin K antagonist

Other group

Treatment:

Device: HEMOPTIC