Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT03669068
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2018-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}], 'ancestors': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1602}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2018-09-08', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Cardiovascular events', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of therapeutic endoscopy-related gastrointestinal bleeding', 'timeFrame': '3 months', 'description': 'Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal endoscopy', 'Oral anticoagulants', 'Gastrointestinal bleeding', 'Cardiovascular event'], 'conditions': ['Gastrointestinal Bleeding', 'Cardiovascular Complication', 'Anticoagulants; Circulating, Hemorrhagic Disorder', 'Gastrointestinal Endoscopy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years.\n* Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.\n* Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Negative to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03669068', 'briefTitle': 'Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry', 'orgStudyIdInfo': {'id': 'HRC-ENDOHEM-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elective endoscopy', 'description': 'Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding.', 'interventionNames': ['Procedure: Gastrointestinal endoscopy']}, {'label': 'Gastrointestinal bleeding', 'description': 'Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately', 'interventionNames': ['Procedure: Gastrointestinal endoscopy']}], 'interventions': [{'name': 'Gastrointestinal endoscopy', 'type': 'PROCEDURE', 'description': 'Two separated groups will be included in the registry:\n\n1. Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure.\n2. Patients undergoing elective gastrointestinal endoscopy.', 'armGroupLabels': ['Elective endoscopy', 'Gastrointestinal bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Available. Timeframe: 2018-2021', 'ipdSharing': 'YES', 'accessCriteria': 'Accredited researchers. The protocol is available in Spanish and will be provided by contacting the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Salamanca', 'class': 'OTHER'}, {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital de Viladecans', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital de Avilés', 'class': 'UNKNOWN'}, {'name': 'Hospital General de Villalba', 'class': 'UNKNOWN'}, {'name': 'Hospital General de Granollers', 'class': 'UNKNOWN'}, {'name': 'Hospital Sant Pau', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator. MSc. Gastroenterologist', 'investigatorFullName': 'Enrique Rodríguez de Santiago', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}