Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669068
• Other study ID #: HRC-ENDOHEM-02
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1602
• Est. completion date: May 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (12)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal	Hospital Clinic of Barcelona, Hospital de Avilés, Hospital de Viladecans, Hospital del Mar, Hospital General de Granollers, Hospital General de Villalba, Hospital Sant Pau, Hospital Universitario 12 de Octubre, Hospital Universitario Central de Asturias, Puerta de Hierro University Hospital, University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of therapeutic endoscopy-related gastrointestinal bleeding	Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding	3 months