International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly (INR-Cap pilote)
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pont St Esprit, Francia, 30130
- EHPAD de l'Hôpital de Pont Saint Esprit
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
- The patient must be insured or beneficiary of a health insurance plan
- The patient treated with vitamin K antagonist for over six months
- The patient must have given his/her informed and signed consent
- For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent
Exclusion Criteria:
- The patient is under judicial protection
- The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
- It is impossible to correctly inform the patient, or his/her legal guardian
- The patient, or his/her legal guardian, refuses to sign the consent
- The patient is participating in another interventional study, or has participated in another interventional study within the past three months
- The patient is in an exclusion period determined by a previous study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: The study population
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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Is the capillary INR concordant with the venous INR ? yes/no
Periodo de tiempo: 6 months
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Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The number of thromboembolic events per patient
Periodo de tiempo: 6 months
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6 months
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The number of bleeding events per patient
Periodo de tiempo: 6 months
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6 months
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The number of thromboembolic or bleeding events per patient
Periodo de tiempo: 6 months
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6 months
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Coefficient of variation for capillary INR measures per patient
Periodo de tiempo: 6 months
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6 months
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Time in therapeutique range (days)
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Chloé Sikirdji, Interne, Centre Hospitalier Universitaire de Nîmes
- Investigador principal: Jean-François Clape, MD, Centre Hospitalier Universitaire de Nîmes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- LOCAL/2015/CS-01
- 2015-A01056-43 (Otro identificador: RCB number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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