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Completed

NCT Number: NCT02614573

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

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).

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Key information

Conditions

Aged Nursing Homes

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD de l'Hôpital de Pont Saint Esprit

Pont-Saint-Esprit, 30130, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoagucheckXSR Capillary INR measures

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.

Other names: CoagucheckXSR

Primary outcomes

  1. Is the capillary INR concordant with the venous INR ? yes/no

    Time frame: 6 months

    Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant

Secondary outcomes

  1. The number of thromboembolic events per patient

    Time frame: 6 months

  2. The number of bleeding events per patient

    Time frame: 6 months

  3. The number of thromboembolic or bleeding events per patient

    Time frame: 6 months

  4. Coefficient of variation for capillary INR measures per patient

    Time frame: 6 months

  5. Time in therapeutique range (days)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: INR-Cap pilote

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2015
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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