Overview

Condition anticoagulant disorders
Treatment endoscopic procedure
Sponsor Valduce Hospital
Start date March 2016
End date May 2017
Trial size 500 participants
Trial identifier NCT02734316, Version 3 10/2/216

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Italy

Study Design

Observational model cohort
Time perspective cross-sectional

Primary Outcomes

Measure
incidence of hemorrhagic events after endoscopic procedures
time frame: 12 months

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Valduce Hospital.