NCT01477528已完成不适用
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 18
- 主要终点
- Rate of thromboembolic events and hemorrhagic events
研究概览
简要总结
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HeartMate II Left Ventricular Assist Device (LVAD) patient
- •Patient has signed an informed consent for data collection.
- •Patient was discharged, or is being discharged, from the hospital after their initial LVAD implant surgery.
- •at time of enrolling in study, is currently on, with the intention of being maintained on reduced anti-thrombotic therapy (RT) for chronic long-term management.
- •- On or after January 1, 2011 patient was being maintained on, or had been initiated with the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic long-term management; but where RT was subsequently discontinued due to an adverse event or transplant, explant, or death.
排除标准
- •Patients under acute management of anti-thrombotic agents before a final decision on long term antithrombotic strategy.
- •Patients requiring a legal representative to sign consent form, rather than themselves.
- •Patient is being managed on other anti-thrombotic agents
结局指标
主要结局
Rate of thromboembolic events and hemorrhagic events
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (18)
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