Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

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.

Conditions

• Gastrointestinal Bleeding
• Cardiovascular Complication
• Anticoagulants; Circulating, Hemorrhagic Disorder
• Gastrointestinal Endoscopy

Interventions

PROCEDURE

Gastrointestinal endoscopy

Two separated groups will be included in the registry: 1. Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure. 2. Patients undergoing elective gastrointestinal endoscopy.

Sponsors & Collaborators

• University of Salamanca

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Puerta de Hierro University Hospital

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital de Viladecans

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital de Avilés

  collaborator UNKNOWN

• Hospital General de Villalba

  collaborator UNKNOWN

• Hospital General de Granollers

  collaborator UNKNOWN

• Hospital Sant Pau

  collaborator UNKNOWN

• Hospital Universitario Ramon y Cajal

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2020-04-01

Completion

2020-05-30

Countries

• Spain

Study Locations