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| Name | Class |
|---|---|
| University of Salamanca | OTHER |
| Hospital Universitario Central de Asturias | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
| Puerta de Hierro University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective endoscopy | Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding. |
| |
| Gastrointestinal bleeding | Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrointestinal endoscopy | Procedure | Two separated groups will be included in the registry:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
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Available. Timeframe: 2018-2021
Accredited researchers. The protocol is available in Spanish and will be provided by contacting the principal investigator.
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| OTHER |
| Hospital del Mar | OTHER |
| Hospital de Viladecans | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital de Avilés | UNKNOWN |
| Hospital General de Villalba | UNKNOWN |
| Hospital General de Granollers | UNKNOWN |
| Hospital Sant Pau | UNKNOWN |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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