Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.

NCT05561244 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-03

Study results available
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Summary

This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.

Conditions

Interventions

DEVICE

Weekly monitoring using the capillary International Normalised Ratio strategy

Patients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Chloé SIKIRDJI, Dr. · CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9

  • Karen ZERBIB, Dr. · EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES

  • Patrick DUTILLEUL, Dr. · EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT

  • Alain BROUSSE, Dr. · EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZES

  • Elodie MILLION, Dr. · EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIER

  • Philippe SERAYET, Dr. · EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNES

  • Thierry CORNILLE, Dr. · EHPAD "Docteur Henry Granet", 23 Chemin de la grave 30390 ARAMON +EHPAD "Les oliviers", 420 Chem. de Ceserac 30490 MONTFRIN

  • Gilles SEYLER, Dr. · EHPAD "les Caprésianes",111 r. Alphonse Daudet 30210 CABRIERES, "Villa Rediciano", 6 r. du 19 Mars 1962, 30129 REDESSAN

  • Gil MEYRAND, Dr. · EHPAD "Les Jasses", 155 Rue des Clapas 30730 FONS

  • Philippe VERNEDE, Dr. · EHPAD "Jacques Saurin", Avenue des Loisirs 30190 MOUSSAC

  • Katia BRUNEL, Dr. · EHPAD "Jean Lasserre", Chem. des Camisards 30360 EUZET

  • Georges ALVADO, Dr. · EHPAD "Les Capitelles", Impasse de la Thebaide 30620 BERNIS

  • Christine DE TADDEO, Dr. · EHPAD Serre-Cavalier - Sites 1 & 2, Rue Pitot Prolongée 30000 Nîmes

  • Marie-Hélène GRAS-JAEN, Dr. · EHPAD ORPEA "Château notre dame", Pl. du Château 30730 PARIGNARGUES

  • Marc BORGHERO, Dr. · EHPAD Samdo Rochebelle, 17 Rue des Châtaigniers 30100 ALES

  • Anne-Laure VITEAU, Dr. · EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS

  • Abderrahmane ALOUI, Dr. · EHPAD Korian "Les Meunières" Place Denfert Rochereau 34400 LUNEL

  • Pierre MERLE, Dr. · EHPAD du Centre hospitalier de Langogne, Clos de la Tuilerie 48300 LANGOGNE

  • Marc DUPUIS, Dr. · EHPAD Saint-Vincent de Paul,16 Rue de l'Égalité 30240 LE GRAU-DU-ROI

  • Julie LANO, Dr. · EHPAD "Coté Canal", 116 Rue Jacques Cœur 30220 AIGUES-MORTES

  • Florence CHAPOUTOUT, Dr. · EHPAD "La belle viste", 149 Rue du parc BP 2 34980 ST GELY DU FESC

  • Nicole GARCIA, Dr. · EHPAD "Les monts d'Aurelle",Parc Euromedecine 1632 Rue St Priest 34097 MONTPELLIER CEDEX 5

  • Robert LE STUM, Dr. · Maison de Retraite Protestante, 2252 Rte de Mende 34090 MONTPELLIER

  • Marie-Aude BONNEL, Dr. · EHPAD "les Dominicaines",2 Rue du Thirondel 34190 GANGES

  • Adrien ROMARY, Dr. · EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES

  • Mélanie BADIN, Dr. · 68 rue du charron 30310 VERGEZE

  • Murielle GLONDU-LASSIS, Dr. · SCM Médicale St Bauzille de Putois 1193 avenue du chemin neuf 34190 ST BAUZILLE DE PUTOIS

  • Hermine SAGUY, Dr. · 2 rue Ibn Sinaï Dit Avicenne 66330 Cabestany

  • Anne-Sophie ODOUL, Dr. · 392 Boulevard Pedro de Luna 34070 MONTPELLIER

  • Victor LIVIOT, Dr. · EHPAD Léon Bourgeois 1 Place du Puig Tarrous 66740 VILLELONGUE DELS MONTS

  • Philippe Roure, Dr. · EHPAD La Pinède 110 chemin des cades 30310 Vergeze

  • Franck Raschilas, Dr. · Centre Bellevue-CHU Montpellier 1 Pl. Jean Baumel 34090 Montpellier

  • Chloé Loeffler, Dr. · EHPAD La Murelle Avenue de la Gare 34480 - LAURENS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2024-12-13
Completion
2024-12-13

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561244 on ClinicalTrials.gov