Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-03 @ 6:54 PM
Study NCT ID:
NCT03894202
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Aneurysm ultra-early treatment modality', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale in subgroups of Microsurgical Treatment versus Endovascular Treatment, minimum is 0 and maximum is 6 and the lower the better'}, {'measure': 'Neurological Status of Patients underwent Ultra-early Aneurysm Treatment', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale in subgroups with WFNS Grade IV versus Patients with WFNS Grade V, minimum is 0 and maximum is 6 and the lower the better'}, {'measure': 'Time of Ultra-early Aneurysm Treatment', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale in subgroups with Aneurysm Treatment within 6 hours and between 6-24 hours, minimum is 0 and maximum is 6 and the lower the better'}], 'primaryOutcomes': [{'measure': 'Modified Rankin Scale', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale (0-6): 0-2 favourable, 3-6 unfavourable, the minimum is 0, the maximum is 6, lower score is better'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '1, 3, 6 months', 'description': 'Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better'}, {'measure': 'Stroke-Specific Quality of Life', 'timeFrame': '1, 3, 6 months', 'description': 'Minimum is 1, maximum is 5, higher score is better'}, {'measure': 'Short Form-36', 'timeFrame': '1, 3, 6 months', 'description': 'Minimum is 0, maximum is 100, higher score is better'}, {'measure': 'Return-to-Work', 'timeFrame': '1, 3, 6 months', 'description': 'Return to Work: Yes or No, Work Hours and Nature, minimum work hour is 0, maximum work hour is 168 per week, longer work hour is better'}, {'measure': 'Hospital Resource Utilization', 'timeFrame': '6 months', 'description': 'Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This is the first prospective study in Hong Kong that recruit patients with poor neurological status after intracranial aneurysm rupture in all seven public neurosurgical services in Hong Kong. This study assesses whether ultra-early aneurysm treatment improves outcomes in patients with poor neurological status after intracranial aneurysm rupture in Hong Kong. These data are essential to understand the impact of the disease and for future service development in Hong Kong.', 'detailedDescription': 'Objectives:\n\n1. To evaluate outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture in Hong Kong;\n2. To evaluate whether ultra-early aneurysm treatment improves outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture.\n\nHypothesis to be tested: Ultra-early aneurysm treatment increases chance of favorable outcomes in in patients admitted with poor neurological status after intracranial aneurysm rupture.\n\nDesign and subjects: Prospective observational study to recruit consecutive poor grade aneurysmal subarachnoid hemorrhage patients in the seven public neurosurgical services in Hong Kong.\n\nStudy instruments: Modified Rankin Scale, Montreal Cognitive Assessment, Stroke-Specific Quality of Life, Short Form-36, Return to Work, and hospital resource utilization.\n\nGroups: Ultra-early (within initial 24 hours) and non-ultra early aneurysm treatment.\n\nMain outcome measures: Favorable outcome at six months. Data analysis and expected results: Comparisons are carried out with adjustments for age, sex, admission Glasgow Coma Scale, hypertension, and modality of aneurysm treatment with appropriate regression analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intracranial aneurysm rupture (aneurysmal subarachnoid hemorrhage/SAH) admitted to seven public neurosurgical services in Hong Kong', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria for this study are:\n\n1. Adult patients (aged \\>18 years) with spontaneous subarachnoid hemorrhage\n2. Admission into Hospital Authority neurosurgical services\n3. The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5)\n\nThe exclusion criteria for this study are:\n\n1. Patients are likely to leave Hong Kong shortly after episode\n2. Patients (or next-of-kin as appropriate) refuse to participate into the study'}, 'identificationModule': {'nctId': 'NCT03894202', 'acronym': 'UEAT', 'briefTitle': 'Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Assessment of the Impact of Ultra-Early Aneurysm Treatment on Outcomes in Patients With Poor Neurological Status After Intracranial Aneurysm Rupture', 'orgStudyIdInfo': {'id': 'GWHMRF2018001'}, 'secondaryIdInfos': [{'id': '06170516', 'type': 'OTHER_GRANT', 'domain': 'Food and Health Bureau, Hong Kong'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultra-early aneurysm treatment', 'description': 'Ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping within the initial twenty-four hours.'}, {'label': 'Non-ultra-early aneurysm treatment', 'description': 'Non-ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping after the initial twenty-four hours.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Surgery, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'George KC Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food and Health Bureau, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'George KC Wong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}