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OpenTrials
Completed

NCT Number: NCT02734316

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

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.

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Key information

Conditions

Anticoagulant Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Valduce Hospital

Como, 22100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • inform consent not possible to obtain
  • not willing patient

Treatment and study plan

endoscopic procedure

Other

Evaluation of adverse events in patients on DOACs undergoing GI endoscopy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.