Anticoagulant Disorders Clinical Trial
Official title:
Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study
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.
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
;