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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pont St Esprit、法国、30130
- EHPAD de l'Hôpital de Pont Saint Esprit
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Is the capillary INR concordant with the venous INR ? yes/no
大体时间：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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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The number of thromboembolic events per patient
大体时间：6 months
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6 months
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The number of bleeding events per patient
大体时间：6 months
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6 months
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The number of thromboembolic or bleeding events per patient
大体时间：6 months
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6 months
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Coefficient of variation for capillary INR measures per patient
大体时间：6 months
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6 months
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Time in therapeutique range (days)
大体时间：6 months
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6 months
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合作者和调查者
调查人员
- 研究主任：Chloé Sikirdji, Interne、Centre Hospitalier Universitaire de Nîmes
- 首席研究员：Jean-François Clape, MD、Centre Hospitalier Universitaire de Nîmes
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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