Status:
COMPLETED
INR at Home Measurement by the LabPad® Point-of-care in Patients on Vitamin K Antagonist Drugs (VKA)
Lead Sponsor:
Medicalps
Collaborating Sponsors:
AG2R La Mondiale
AVALUN
Conditions:
Vitamine K Antagonist (VKA) Treatment
International Normalized Ratio (INR) Measure at Home
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 mont...
Detailed 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 Internation...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04117048
Start Date
October 3 2019
End Date
April 3 2020
Last Update
April 6 2020
Active Locations (1)
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1
Laboratoire ORIADE NOVIALE
Saint-Marcellin, France, 38160