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

NCT02614573 | Completed

• 2 other identifiers: LOCAL/2015/CS-012015-A01056-43
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Aged; Nursing Homes

Keywords

Dependent; Aged, 80 and over; Aged

Outcome Measures

Primary Outcomes (1)

• Is the capillary INR concordant with the venous INR ? yes/no

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

  6 months

Secondary Outcomes (5)

• The number of thromboembolic events per patient

  6 months

• The number of bleeding events per patient

  6 months

• The number of thromboembolic or bleeding events per patient

  6 months

• Coefficient of variation for capillary INR measures per patient

  6 months

• Time in therapeutique range (days)

  6 months

Study Arms (1)

The study population

EXPERIMENTAL

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.

Device: CoagucheckXSR Capillary INR measures

Interventions

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.

Also known as: CoagucheckXSR

The study population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

EHPAD de l'Hôpital de Pont Saint Esprit

Pont-Saint-Esprit, 30130, France

Location

Related Publications (1)

• 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.

  PMID: 31713344 RESULT

Study Officials

• Chloé Sikirdji, Interne

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Jean-François Clape, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 25, 2015
• Study Start: February 1, 2016
• Primary Completion: August 13, 2016
• Study Completion: August 13, 2016
• Last Updated: November 19, 2025

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)