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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT02614573
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aged; Nursing Homes	Device: CoagucheckXSR Capillary INR measures	N/A

Detailed Description

The secondary objectives of this study are to:

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

2. 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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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.; Other Names: CoagucheckXSR

Outcome Measures

Primary Outcome Measures

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

1. The number of thromboembolic events per patient [6 months]

2. The number of bleeding events per patient [6 months]

3. The number of thromboembolic or bleeding events per patient [6 months]

4. Coefficient of variation for capillary INR measures per patient [6 months]

5. Time in therapeutique range (days) [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EHPAD de l'Hôpital de Pont Saint Esprit	Pont St Esprit		France	30130

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Study Director: Chloé Sikirdji, Interne, Centre Hospitalier Universitaire de Nîmes
• Principal Investigator: Jean-François Clape, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT02614573
• Other Study ID Numbers: LOCAL/2015/CS-01; 2015-A01056-43
• First Posted: Nov 25, 2015
• Last Update Posted: Aug 25, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Centre Hospitalier Universitaire de Nīmes: Dependent; Aged, 80 and over; Aged

Study Results

No Results Posted as of Aug 25, 2016