International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly

NCT ID: NCT02614573

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-08-13

Brief Summary

The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).

Detailed Description

The secondary objectives of this study are to:

A. Estimate the intra-patient variability of capillary INR measures.

B. Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.

C. Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.

Conditions

Aged; Nursing Homes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

The study population

The clinical phases of this study will be held in the nursing home (EHPAD; principal building + 2 annexes) of Pont-Saint-Esprit, located in France. Patients are elderly dependents treated by anti-vitamin K for more than 6 months.

Group Type: EXPERIMENTAL

CoagucheckXSR Capillary INR measures

Intervention Type: DEVICE

We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events.

If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol.

If capillary INR is > 4, then verification by venous measure and refer to general practitioner.

Interventions

CoagucheckXSR Capillary INR measures

We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events.

If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol.

If capillary INR is > 4, then verification by venous measure and refer to general practitioner.

Intervention Type: DEVICE

Other Intervention Names

CoagucheckXSR

Eligibility Criteria

Inclusion Criteria

• The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
• The patient must be insured or beneficiary of a health insurance plan
• The patient treated with vitamin K antagonist for over six months
• The patient must have given his/her informed and signed consent
• For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent

Exclusion Criteria

• The patient is under judicial protection
• The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
• It is impossible to correctly inform the patient, or his/her legal guardian
• The patient, or his/her legal guardian, refuses to sign the consent
• The patient is participating in another interventional study, or has participated in another interventional study within the past three months
• The patient is in an exclusion period determined by a previous study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chloé Sikirdji, Interne

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Jean-François Clape, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

EHPAD de l'Hôpital de Pont Saint Esprit

Pont-Saint-Esprit, , France

Countries

France

References

Sikirdji C, Costa D, Alonso S, Clape JF, Amouyal M, de Waziere B, Fabbro-Peray P. Assessment of agreement and time in therapeutic range of capillary versus venous international normalised ratio in frail elderly people in a nursing home. Intern Med J. 2019 Nov;49(11):1442-1446. doi: 10.1111/imj.14626.

Reference Type: RESULT

PMID: 31713344 (View on PubMed)

Other Identifiers

2015-A01056-43

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/CS-01

Identifier Type: -

Identifier Source: org_study_id