Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

Study Overview
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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.

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

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

Intervention / Treatment
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* Procedure: Gastrointestinal endoscopy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elective endoscopy<br>Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding. | Procedure: Gastrointestinal endoscopy<br>* 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.<br>|
| Gastrointestinal bleeding<br>Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately | Procedure: Gastrointestinal endoscopy<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal endoscopy, Oral anticoagulants, Gastrointestinal bleeding, Cardiovascular event