INR at Home Measurement by the LabPad® Point-of-care in Patients on Vitamin K Antagonist Drugs (VKA) (INRADOM)

Medicalps

Status

Completed

Conditions

Vitamine K Antagonist (VKA) Treatment

International Normalized Ratio (INR) Measure at Home

Thromboembolic Pathology

Treatments

Device: LabPad® point-of-care

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04117048

RCB 2019-A01357-50

Details and patient eligibility

About

This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.

Full description

The impact of the LabPad® point-of-care use by the nurse will be evaluated in the patients on vitamine K antagonist (VKA) treatment by measuring the time elapsed between the reading of the International Normalized Ratio (INR) by the LabPad® at patient's home and the validation of the biological measure, The time that the patient spends in his therapeutic range will be measured. The adverse events related to VKA will also be collected. At the end of the study, the patient will complete satisfaction and usage questionnaires about the LabPad®.

This study will be performed for 6 months.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient over 18 years of age
Patient treated with VKA and without any heparin - VKA relay
Patient able to read and understand the procedure, and able to express consent for the study

Exclusion criteria

Patient treated with heparin
Patient treated with direct oral anticoagulants (DAOs)
Patient with antiphospholipid antibody syndrome (APA)
Patient not available or wishing to change region within one year of inclusion
Patient currently participating or having participated in the month preceding the inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
Persons referred to in Articles L.1121-5 to L.1121-8 of the French Public Health Law (corresponds to all protected persons: pregnant woman (verified by the dosage of β- human chorionic gonadotropin for any woman wishing to participate in the protocol and of childbearing age < 60 years), parturient, nursing woman, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)