Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Completed

• Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder; Cardiovascular Complication; Gastrointestinal Bleeding; Gastrointestinal Endoscopy
• Interventions: Procedure: Gastrointestinal endoscopy

• Registration Number: NCT03669068
• Lead Sponsor: Hospital Universitario Ramon y Cajal

Brief Summary

This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Primary Completion: 2020-04-01
• Study Completion: 2020-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1602

Inclusion Criteria

• Age >= 18 years.
• Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.
• Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.
• Signed informed consent.

Exclusion Criteria

• Negative to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective endoscopy	Gastrointestinal endoscopy	Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding.
Gastrointestinal bleeding	Gastrointestinal endoscopy	Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately

Primary Outcome Measures

Name	Time	Method
Incidence of Cardiovascular events	3 months	Nº of patients during the study period presenting with a cardiovascular event, defined as any of the following entities: pulmonary thromboembolism, venous thromboembolism, acute coronary syndrome, arterial peripheral embolism or cerebrovascular accident.

Secondary Outcome Measures

Name	Time	Method
Incidence of therapeutic endoscopy-related gastrointestinal bleeding	3 months	Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain