Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Overview

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.

Full Title of Study: “Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry”

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: April 1, 2020

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• Incidence of Cardiovascular events
  • Time Frame: 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 Measures

• Incidence of therapeutic endoscopy-related gastrointestinal bleeding
  • Time Frame: 3 months
  • Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Hospital Universitario Ramon y Cajal
• Collaborator
  • University of Salamanca
• Provider of Information About this Clinical Study
  • Principal Investigator: Enrique Rodríguez de Santiago, Principal Investigator. MSc. Gastroenterologist – Hospital Universitario Ramon y Cajal