NCT02614573

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-08-13
• Completion: 2016-08-13
• First posted: 2015-11-25
• Last updated: 2025-11-19

Locations

1 site across 1 country: France