Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures
|Start date||March 2016|
|End date||May 2017|
|Trial size||500 participants|
|Trial identifier||NCT02734316, Version 3 10/2/216|
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.
incidence of hemorrhagic events after endoscopic procedures
time frame: 12 months
Male or female participants of any age.
Inclusion Criteria: - patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy Exclusion Criteria: - inform consent not possible to obtain - not willing patient
|Official title||Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study|
|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 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 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|
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