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

Aged Clinical Trial

— INR-Cap pilote  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614573
• Other study ID #: LOCAL/2015/CS-01
• Secondary ID: 2015-A01056-43
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: August 24, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aged
• Nursing Homes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	EHPAD de l'Hôpital de Pont Saint Esprit	Pont St Esprit

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The number of thromboembolic events per patient		6 months	Yes
Secondary	The number of bleeding events per patient		6 months	Yes
Secondary	The number of thromboembolic or bleeding events per patient		6 months	Yes
Secondary	Coefficient of variation for capillary INR measures per patient		6 months	No
Secondary	Time in therapeutique range (days)		6 months	No