NCT03532724已完成不适用
Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 927 人开始时间: 2017年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 927
- 试验地点
- 1
- 主要终点
- Thromboembolic events
研究概览
简要总结
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
- •Signed informed consent
排除标准
- •Patients younger than 18 years old
结局指标
主要结局
Thromboembolic events
时间窗: since 1 of july of 2002 to 30th of june of 2018
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Major hemorrhagic event
时间窗: since 1 of july of 2002 to 30th of june of 2018
Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale
次要结局
- Mortality(since 1 of july of 2002 to 30th of june of 2018)
研究者
研究点 (1)
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