Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- hemorrhagic or thromboembolic events evaluation
研究概览
简要总结
Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Informed consent
- •Evidence of CSDH which needs surgery
- •patients taking antithrombotics or anticoagulants
排除标准
- •previous surgery for CSDH
结局指标
主要结局
hemorrhagic or thromboembolic events evaluation
时间窗: up to 6 months after surgery
hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis)
次要结局
未报告次要终点
研究者
Dott.ssa Alba Scerrati
Principal Investigator
University Hospital of Ferrara