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

NCT04117048 | Completed

• 1 other identifier: RCB 2019-A01357-50
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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 months.

Conditions

Vitamine K Antagonist (VKA) Treatment; International Normalized Ratio (INR) Measure at Home; Thromboembolic Pathology

Keywords

INR; Labpad®; VKA

Outcome Measures

Primary Outcomes (1)

• Patient follow up time, regardless of the value of the INR

  Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, regardless of the value of the INR

  During 6 months of use

Secondary Outcomes (5)

• Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)

  During 6 months of use

• Time in Therapeutic Range

  During 6 months of use

• Number of adverse events related to VKA

  During 6 months of use

• Patient's satisfaction about the LabPad®: Satisfaction Questionnaire

  After 6 months of use

• LabPad® patient's use

  After 6 months of use

Study Arms (1)

At home INR measurement with LabPad®

EXPERIMENTAL

All at home INR measurements will be performed with the LabPad® point-of-care

Device: LabPad® point-of-care

Interventions

LabPad® point-of-care DEVICE

All at home INR measurements will be performed by the nurse using the LabPad® point-of-care

At home INR measurement with LabPad®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient treated with heparin
• Patient treated with direct oral anticoagulants (DAOs)
• Patient with antiphospholipid antibody syndrome (APA)
• 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)

Sponsors & Collaborators

• Medicalps: lead
• AG2R La Mondiale: collaborator
• AVALUN: collaborator
• Icadom: collaborator
• ORIADE NOVIALE: collaborator
• SIL-LAB INNOVATIONS: collaborator
• TASDA: collaborator

Study Sites (1)

Laboratoire ORIADE NOVIALE

Saint-Marcellin, 38160, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients included benefit from at home INR measure

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 3, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)