Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- incidence of hemorrhagic events after endoscopic procedures
研究概览
简要总结
The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.
详细描述
This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with.
All consecutive patients undergoing elective procedures and providing informed consent will be included.
Primary end-point:
incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines
Secondary end points:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy
排除标准
- •inform consent not possible to obtain
- •not willing patient
结局指标
主要结局
incidence of hemorrhagic events after endoscopic procedures
时间窗: 12 months
incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed
次要结局
未报告次要终点
研究者
Franco Radaelli
MD
Valduce Hospital