Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Madrid Health Service

Status: Completed

Conditions: Gastrointestinal Endoscopy; Anticoagulants; Circulating, Hemorrhagic Disorder; Cardiovascular Complication; Gastrointestinal Bleeding

Treatments: Procedure: Gastrointestinal endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT03669068

HRC-ENDOHEM-02

Details and patient eligibility

About

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.

Enrollment: 1,602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,602 participants in 2 patient groups

Elective endoscopy

Description:

Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding.

Treatment:

Procedure: Gastrointestinal endoscopy

Gastrointestinal bleeding

Description:

Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately

Treatment:

Procedure: Gastrointestinal endoscopy