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

NCT ID: NCT05561244

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2024-12-13

Brief Summary

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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.

Detailed Description

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Biological monitoring is essential to avoid strokes, deep vein thrombosis and hemorrhage. Generally speaking, this consists of a venous sampling for the international normalized ratio (INR), for which the therapeutic target is approximately 2.5 (tolerance range between 2 and 3) for atrial fibrillation (AF) and deep vein thrombosis (DVT). INR values below 2 indicate high risks of a stroke or DVT, whereas INR values over 3 refer to high risks of hemorrhage. INR monitoring requires monthly follow-ups or even more frequently if the HAS BLED score is ≥ 3.

One parameter used to evaluate the benefit/risk ratio is the "time in therapeutic range" (TTR), referring to the time spent within the INR therapeutic target (INR between 2 and 3 for patients with Atrial Fibrillation/ Deep Vein Thrombosis). It is calculated using the Rosendaal method. According to the "European Society of Cardiology" guidelines, the minimum threshold necessary for a good risk/benefit ratio is 70%. In other countries, it has been shown that the TTR is higher: 61% in Canada, 64.4% in Spain, 68.9% in Italy and 76.2% in Sweden. Moreover, TTR determines the benefit/risk ratio of the treatment, which means that patients with a TTR \< 60% have more than 2% absolute total mortality per patient-year compared to patients with TTR \> 60%.

As for the pilot study (Manuscript accepted in August 2019 in the Journal of Internal Medicine ), we expect approximately half the patients to be aged over 90. Patients will be recruited in nursing homes where they are monitored by nurses and care quality managers who are responsible for ensuring compliance with good clinical practices. This limits the risk of non-compliance with preanalytical venous INR conditions. Eighteen percent of subjects over 85 are treated with vitamin-K antagonists (VKA). For elderly patients with atrial fibrillation (AF) or deep venous thrombosis (DVT), stroke prophylaxis is a real clinical challenge. VKA treatments are indicated for the prevention of strokes in patients with Atrial Fibrillation, DVT or those who have received heart valve implants. VKAs have a narrow therapeutic range: if they are under-dosed, the risk of embolism (AVC and DVT) is high, whereas in the event of an overdose, the risk of bleeding is high. Given the annual incidence of severe hemorrhage (3-5%), the risk of a hemorrhage is their main side effect. The incidence of brain hemorrhages is 0.6 per 100 patient-years, for gastrointestinal bleeding it is 1.0 per 100 patient-years, and the risk of other serious bleeding is 1.4 per 100 patient-years. This risk of bleeding is usually assessed using the HAS-BLED score. The risk of hemorrhage is 4.2% per year in patients over 75 versus 1.7% per year for those under 75.

Following the results of a pilot study (manuscript accepted in the Journal of Internal Medecine), the hypothesis is that a weekly monitoring strategy for capillary INR should increase the TTR of nursing home patients by 12% compared to the usual monitoring by venous INR, resulting in a decrease of thrombotic or hemorrhagic events.

Conditions

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Atrial Fibrillation Deep Vein Thrombosis Stroke

Keywords

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Atrial Fibrillation Thrombosis Stroke Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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CONTROL GROUP

Control group (n = 16 nursing homes, 64 patients): Patients will be monitored as usual using the Venous International Normalised Ratio strategy. Practices will not be changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients will not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.

Group Type NO_INTERVENTION

No interventions assigned to this group

INTERVENTIONAL GROUP

Intervention group (n = 16 nursing homes, 64 patients): 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.

Group Type EXPERIMENTAL

Weekly monitoring using the capillary International Normalised Ratio strategy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient or his/her trusted-person/legal representative/tutor signed the consent form
* The patient is an adult and lives in a nursing home
* The patient has been on treatment with Vitamin K Antagonists for more than six months
* The patient's target INR range is 2,5 \[2-3\] or 3 \[2,5-3,5\]
* The patient is affiliated to a health insurance program

Exclusion Criteria

* The patient is participating in a Type 1 interventional study involving human beings (Jardé law).
* The patient is in an exclusion period determined by another study
* The patient is under safeguard of justice.
* It is not possible to give the patient (or his/her trusted-person/legal representative/tutor) informed information.
* The patient has a short life expectancy (\< 1 month)
* The Karnofky index is ≤ 20%
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé SIKIRDJI, Dr.

Role: PRINCIPAL_INVESTIGATOR

CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9

Karen ZERBIB, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES

Patrick DUTILLEUL, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT

Alain BROUSSE, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZES

Elodie MILLION, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIER

Philippe SERAYET, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNES

Thierry CORNILLE, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Gilles SEYLER, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Gil MEYRAND, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Les Jasses", 155 Rue des Clapas 30730 FONS

Philippe VERNEDE, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Jacques Saurin", Avenue des Loisirs 30190 MOUSSAC

Katia BRUNEL, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Jean Lasserre", Chem. des Camisards 30360 EUZET

Georges ALVADO, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Les Capitelles", Impasse de la Thebaide 30620 BERNIS

Christine DE TADDEO, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Serre-Cavalier - Sites 1 & 2, Rue Pitot Prolongée 30000 Nîmes

Marie-Hélène GRAS-JAEN, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD ORPEA "Château notre dame", Pl. du Château 30730 PARIGNARGUES

Marc BORGHERO, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Samdo Rochebelle, 17 Rue des Châtaigniers 30100 ALES

Anne-Laure VITEAU, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS

Abderrahmane ALOUI, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Korian "Les Meunières" Place Denfert Rochereau 34400 LUNEL

Pierre MERLE, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD du Centre hospitalier de Langogne, Clos de la Tuilerie 48300 LANGOGNE

Marc DUPUIS, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Saint-Vincent de Paul,16 Rue de l'Égalité 30240 LE GRAU-DU-ROI

Julie LANO, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Coté Canal", 116 Rue Jacques Cœur 30220 AIGUES-MORTES

Florence CHAPOUTOUT, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "La belle viste", 149 Rue du parc BP 2 34980 ST GELY DU FESC

Nicole GARCIA, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Les monts d'Aurelle",Parc Euromedecine 1632 Rue St Priest 34097 MONTPELLIER CEDEX 5

Robert LE STUM, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maison de Retraite Protestante, 2252 Rte de Mende 34090 MONTPELLIER

Marie-Aude BONNEL, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "les Dominicaines",2 Rue du Thirondel 34190 GANGES

Adrien ROMARY, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES

Mélanie BADIN, Dr.

Role: PRINCIPAL_INVESTIGATOR

68 rue du charron 30310 VERGEZE

Murielle GLONDU-LASSIS, Dr.

Role: PRINCIPAL_INVESTIGATOR

SCM Médicale St Bauzille de Putois 1193 avenue du chemin neuf 34190 ST BAUZILLE DE PUTOIS

Hermine SAGUY, Dr.

Role: PRINCIPAL_INVESTIGATOR

2 rue Ibn Sinaï Dit Avicenne 66330 Cabestany

Anne-Sophie ODOUL, Dr.

Role: PRINCIPAL_INVESTIGATOR

392 Boulevard Pedro de Luna 34070 MONTPELLIER

Victor LIVIOT, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD Léon Bourgeois 1 Place du Puig Tarrous 66740 VILLELONGUE DELS MONTS

Philippe Roure, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD La Pinède 110 chemin des cades 30310 Vergeze

Franck Raschilas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centre Bellevue-CHU Montpellier 1 Pl. Jean Baumel 34090 Montpellier

Chloé Loeffler, Dr.

Role: PRINCIPAL_INVESTIGATOR

EHPAD La Murelle Avenue de la Gare 34480 - LAURENS

Locations

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EHPAD " Coté Canal "

Aigues-Mortes, GARD, France

Site Status

EHPAD "Samdo Rochebelle"

Alès, GARD, France

Site Status

EHPAD "Docteur Henry Granet"

Aramon, GARD, France

Site Status

EHPAD "Les Capitelles"

Bernis, GARD, France

Site Status

EHPAD Résidence "Les Caprésianes"

Cabrières, GARD, France

Site Status

EHPAD "Jean Lasserre"

Euzet, GARD, France

Site Status

EHPAD "Les Jasses"

Fons, GARD, France

Site Status

EHPAD "Les 5 sens Garons"

Garons, GARD, France

Site Status

EHPAD Saint-Vincent de Paul

Le Grau-du-Roi, GARD, France

Site Status

EHPAD "Sophia la Capitelle"

Meynes, GARD, France

Site Status

EHPAD "Les oliviers"

Montfrin, GARD, France

Site Status

EHPAD "Jacques Saurin"

Moussac, GARD, France

Site Status

EHPAD "Ma Maison"

Nîmes, GARD, France

Site Status

EHPAD Serre-Cavalier Sites 1 and 2

Nîmes, GARD, France

Site Status

Nîmes University Hospital, Place du Pr. Debré

Nîmes, Gard, France

Site Status

EHPAD ORPEA "Château Notre Dame"

Parignargues, GARD, France

Site Status

EHPAD "Villa Rediciano"

Redessan, GARD, France

Site Status

EHPAD "Résidence les Magnans"

Saint-Martin-de-Valgalgues, GARD, France

Site Status

EHPAD "Les Jardins de l'Escalette"

Uzès, GARD, France

Site Status

EHPAD Résidence "l'Accueil"

Vauvert, GARD, France

Site Status

EHPAD Korian "Les Meunières"

Lunel, HERAULT, France

Site Status

EHPAD Malbosc

Montpellier, HERAULT, France

Site Status

SCM Médicale St Bauzille de Putois

Saint-Bauzille-de-Putois, HERAULT, France

Site Status

EHPAD "Les Dominicaines"

Ganges, Hérault, France

Site Status

Maison de Retraite Protestante

Montpellier, Hérault, France

Site Status

EHPAD "Les Monts d'Aurelle"

Montpellier, Hérault, France

Site Status

EHPAD "La BELLE Viste"

Saint-Gély-du-Fesc, Hérault, France

Site Status

EHPAD du centre hospitalier de Langogne

Langogne, LOZERE, France

Site Status

EHPAD La Murelle

Laurens, , France

Site Status

Centre Bellevue-CHU Montpellier

Montpellier, , France

Site Status

EHPAD "Korian Mas de Lauze"

Nîmes, , France

Site Status

EHPAD La Pinède

Vergèze, , France

Site Status

EHPAD Léon Bourgeois

Vilallonga dels Monts, , France

Site Status

Countries

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France

Other Identifiers

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2022-A00516-37

Identifier Type: -

Identifier Source: org_study_id