TerminatedNot Applicable

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

Stopped: In the absence of patients meeting the selection criteria, the study was prematurely terminated. The average number of patients on VKAs per EHPAD has fallen sharply because of the development of direct oral anticoagulants and the Covid crisis.

France45 participantsStarted 2022-11-18

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The population corresponds to nursing homes patients treated with Vitamin K Antagonists for more than six months, because INRc cannot be used while anticoagulation treatment is being introduced. * 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%

What they're measuring

Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy

Timeframe: Over 6 months

Trial details

NCT IDNCT05561244

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-13

Results submitted2026-01-23