Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT03353259
Status:
TERMINATED
Last Update Posted:
2021-10-13
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'C502936', 'term': 'tocilizumab'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'whyStopped': 'DMC concluded that the results of 382 included patients were clear.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence', 'timeFrame': '6 months period after the initial surgery.', 'description': 'To determine the rate in number and percentage of postoperative recurrence requiring re-operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Subdural Hematoma']}, 'descriptionModule': {'briefSummary': 'Primary objectives of the study are to investigate whether adjuvant treatment in the form of Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic subdural hematomaina can:\n\n1. effectively decrease the rate of lesion recurrence requiring re-operation,\n2. effectively shorten the time of lesion resolution.\n\nSecondary objectives of the study are:1) assess the postoperative functional outcome and quality of life of participants, 2) assess the postoperative mortality of participants, 3) assess the treatment safety data, 4) assess the cure rate of participants.', 'detailedDescription': 'Primary endpoints in the study are: 1) determine postoperative recurrence requiring reoperation using clinical examination and CT imaging, 2) determine the time period necessary to complete healing using clinical examination and CT imaging.\n\nSecondary endpoints in the study are: 1) to determine the functional outcome and quality of life of the participants using questionnaires, 2) to determine the mortality of the participants related to chronic subdural hematoma, 3) to determine the treatments complications and adverse events of the participants, 4) to determine the curation using clinical examination and CT imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.\n\nExclusion Criteria:\n\n* patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.'}, 'identificationModule': {'nctId': 'NCT03353259', 'briefTitle': 'Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery', 'orgStudyIdInfo': {'id': '2016/1512/REK nord'}, 'secondaryIdInfos': [{'id': '2017-001670-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'SS-TG', 'description': 'Standard surgery using burr-hole procedure, irrigation and drainage.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SS-TXA-TG', 'description': 'Standard surgery using burr-hole procedure, irrigation and drainage combined withTranexamic acid (Cyklokapron) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day until complete hematoma disappearance.', 'interventionNames': ['Combination Product: Tranexamic acid and Tocilizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SS-TXA-RoA', 'description': 'Standard surgery using burr-hole procedure, irrigation and drainage combined with Tranexamic acid (Cyklokapron) and Tocilizumab (RoActemra) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day combined with RoActemra subcutaneous injection of 162 mg once a week until complete hematoma disappearance.', 'interventionNames': ['Combination Product: Tranexamic acid and Tocilizumab']}], 'interventions': [{'name': 'Tranexamic acid and Tocilizumab', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Cyklokapron and RoActemra'], 'description': 'The first intervention is Tranexamic acid, The second intervention is Tocilizumab', 'armGroupLabels': ['SS-TXA-RoA', 'SS-TXA-TG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Milo Stanisic', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Milo Stanisic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Milo Stanisic', 'investigatorAffiliation': 'Oslo University Hospital'}}}}