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

Completed

• Conditions: Anticoagulant Disorders

• Registration Number: NCT02734316
• Lead Sponsor: Valduce Hospital

Brief 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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Primary Completion: 2017-06
• Study Completion: 2017-06-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 531

Inclusion Criteria

• patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy

Exclusion Criteria

• inform consent not possible to obtain
• not willing patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of hemorrhagic events after endoscopic procedures	12 months	incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed

Trial Locations

Locations (1)

Valduce Hospital; 🇮🇹 Como, Italy