Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

NCT ID: NCT03669068

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elective endoscopy

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

Gastrointestinal endoscopy

Intervention Type PROCEDURE

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.

Gastrointestinal bleeding

Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately

Gastrointestinal endoscopy

Intervention Type PROCEDURE

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.

Interventions

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Gastrointestinal 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salamanca

OTHER

Sponsor Role collaborator

Hospital Universitario Central de Asturias

OTHER

Sponsor Role collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital de Viladecans

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Hospital de Avilés

UNKNOWN

Sponsor Role collaborator

Hospital General de Villalba

UNKNOWN

Sponsor Role collaborator

Hospital General de Granollers

UNKNOWN

Sponsor Role collaborator

Hospital Sant Pau

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Enrique Rodríguez de Santiago

Principal Investigator. MSc. Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HRC-ENDOHEM-02

Identifier Type: -

Identifier Source: org_study_id

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