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

February 6, 2018 updated by: Franco Radaelli, Valduce Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

531

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy, 22100
        • Valduce Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of hemorrhagic events after endoscopic procedures
Time Frame: 12 months
incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Version 3 10/2/216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anticoagulant Disorders

Clinical Trials on endoscopic procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe