An interventional study of CoagucheckXSR Capillary INR measures in Aged and Nursing Homes, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic
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).
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.
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
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.
Also known as: CoagucheckXSR
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
Time frame: 6 months
The number of thromboembolic events per patient
Time frame: 6 months
The number of bleeding events per patient
Time frame: 6 months
The number of thromboembolic or bleeding events per patient
Time frame: 6 months
Coefficient of variation for capillary INR measures per patient
Time frame: 6 months
Time in therapeutique range (days)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes