NCT02734316

Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures

Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 531 (actual)
• Sponsor: Valduce Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * incidence of major bleeding and clinically relent non-major events in the overall patient population * incidence of bleeding events in the overall patient population * incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines * compliance with ESGE guidelines

Conditions

• Anticoagulant Disorders

Interventions

Type	Name	Description
OTHER	endoscopic procedure	Evaluation of adverse events in patients on DOACs undergoing GI endoscopy

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-30
• First posted: 2016-04-12
• Last updated: 2018-02-08

Locations

1 site across 1 country: Italy