Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03669068

Enrollment

1602

Registered

2018-09-13

Start date

2018-01-01

Completion date

2020-05-30

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastrointestinal endoscopy, Oral anticoagulants, Gastrointestinal bleeding, Cardiovascular event

Brief 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.

Interventions

PROCEDUREGastrointestinal 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Cardiovascular events	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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026