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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02734316
Enrollment
531
Registered
2016-04-12
Start date
2016-03-31
Completion date
2017-06-30
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant Disorders

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

Interventions

Evaluation of adverse events in patients on DOACs undergoing GI endoscopy

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* inform consent not possible to obtain * not willing patient

Design outcomes

Primary

MeasureTime frameDescription
incidence of hemorrhagic events after endoscopic procedures12 monthsincidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026