Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry

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.

Study Overview

• Status: Completed
• Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder; Gastrointestinal Endoscopy; Gastrointestinal Bleeding; Cardiovascular Complication
• Intervention / Treatment: Procedure: Gastrointestinal endoscopy

• Study Type: Observational
• Enrollment (Actual): 1602

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Cardiovascular events	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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Hospital Clinic of Barcelona; Hospital del Mar; Hospital Universitario 12 de Octubre; Puerta de Hierro University Hospital; University of Salamanca; Hospital Universitario Central de Asturias; Hospital de Avilés; Hospital de Viladecans; Hospital General de Villalba; Hospital General de Granollers; Hospital Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: September 8, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gastrointestinal endoscopy; Oral anticoagulants; Gastrointestinal bleeding; Cardiovascular event
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Hematologic Diseases; Gastrointestinal Diseases; Hemorrhage; Hemorrhagic Disorders; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HRC-ENDOHEM-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Available. Timeframe: 2018-2021
• IPD Sharing Access Criteria: Accredited researchers. The protocol is available in Spanish and will be provided by contacting the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No