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

Anticoagulant Disorders Clinical Trial

Official title:

Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734316
• Other study ID #: Version 3 10/2/216
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: February 6, 2018
• Start date: March 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2018
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: June 30, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• inform consent not possible to obtain

• not willing patient

Related Conditions & MeSH terms

• Anticoagulant Disorders

Intervention

Other:
• endoscopic procedure
Evaluation of adverse events in patients on DOACs undergoing GI endoscopy

Locations

Country	Name	City	State
Italy	Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hemorrhagic events after endoscopic procedures	incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed	12 months