Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-01 @ 1:58 AM
Study NCT ID:
NCT05079295
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2021-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Anticoagulants and Antithrombotics in Patients With CSDH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2021-10-03', 'studyFirstSubmitQcDate': '2021-10-03', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemorrhagic or thromboembolic events evaluation', 'timeFrame': 'up to 6 months after surgery', 'description': 'hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic subdural hematoma', 'anticoagulants', 'antithrombotics', 'thromboembolic disease', 'cardiovascular risk'], 'conditions': ['Chronic Subdural Hematoma', 'Anticoagulant-induced Bleeding', 'Thromboembolic Stroke', 'Cardiovascular Stroke']}, 'descriptionModule': {'briefSummary': 'Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients suffering from CSDH which needs surgery for its evacuation. Study group will be all patients taking anticoagulants or antithrombotics; control group will be all patients who are not taking these drugs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Informed consent\n* Evidence of CSDH which needs surgery\n* patients taking antithrombotics or anticoagulants\n\nExclusion Criteria:\n\n* previous surgery for CSDH'}, 'identificationModule': {'nctId': 'NCT05079295', 'acronym': 'THERCA', 'briefTitle': 'Management of Anticoagulants and Antithrombotics in Patients With CSDH', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics', 'orgStudyIdInfo': {'id': '1102/2020/Oss/AOUFe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients taking anticoagulants or antithrombotics', 'interventionNames': ['Procedure: CSDH evacuation']}, {'label': 'Group 2', 'description': 'Controls', 'interventionNames': ['Procedure: CSDH evacuation']}], 'interventions': [{'name': 'CSDH evacuation', 'type': 'PROCEDURE', 'description': 'Burr hole for chronic subdural hematomas', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alba Scerrati, MD', 'role': 'CONTACT', 'email': 'scrlba@unife.it', 'phone': '+39532236292'}, {'name': 'Pasquale De Bonis, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giorgio Mantovani, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': "University Hospital Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dott.ssa Alba Scerrati', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}