Economic and Medical Evaluation of Self-monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 919
- 试验地点
- 2
- 主要终点
- Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
研究概览
简要总结
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
详细描述
Rationale/context:
Long term management of anticoagulant treatment is not straightforward, especially in patients bearing mechanical heart valves due to the requirement of maintaining a high INR over a narrow range.
Due to the narrow therapeutic window of AVK, undesirable events (hemorrhages, thromboembolic accidents) tend to be both serious and common leading to frequent admissions to hospital The self-monitoring of AVK, in addition to conventional monitoring of INR in the laboratory, is now being introduced in several countries (USA and Europe).
Main objective To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Secondary objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
- •oral anticoagulant treatment
- •patients with social security cover
- •written informed consent signed by both patient and investigator
排除标准
- •women pregnant or liable to become pregnant during the study
- •nursing women
- •patients unable to master the self-monitoring procedures
- •individuals under judicial control or enquiry
- •patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)
- •patients on dialysis
- •patients with incomplete understanding of instructions
- •blind patients and those unable to read
- •presence of circulating anticoagulant
研究组 & 干预措施
1
Conventional follow-up of anticoagulation
干预措施: Conventional follow-up of anti-coagulation (Device)
2
Self-monitoring of anticoagulation
干预措施: INRatio / Coaguchek XS (Device)
结局指标
主要结局
Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
时间窗: 12 months
次要结局
- - the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve.(12 months)
- the proportion of monthly measurements of INR within the designated range(12 months)
- the inherent cost of each strategy of anticoagulation monitoring(12 month)