Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH
NCT ID: NCT03894202
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
293 participants
OBSERVATIONAL
2019-11-01
2023-03-31
Brief Summary
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Detailed Description
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1. To evaluate outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture in Hong Kong;
2. To evaluate whether ultra-early aneurysm treatment improves outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture.
Hypothesis to be tested: Ultra-early aneurysm treatment increases chance of favorable outcomes in in patients admitted with poor neurological status after intracranial aneurysm rupture.
Design and subjects: Prospective observational study to recruit consecutive poor grade aneurysmal subarachnoid hemorrhage patients in the seven public neurosurgical services in Hong Kong.
Study instruments: Modified Rankin Scale, Montreal Cognitive Assessment, Stroke-Specific Quality of Life, Short Form-36, Return to Work, and hospital resource utilization.
Groups: Ultra-early (within initial 24 hours) and non-ultra early aneurysm treatment.
Main 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ultra-early aneurysm treatment
Ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping within the initial twenty-four hours.
No interventions assigned to this group
Non-ultra-early aneurysm treatment
Non-ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping after the initial twenty-four hours.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Admission into Hospital Authority neurosurgical services
3. The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5)
Exclusion Criteria
2. Patients (or next-of-kin as appropriate) refuse to participate into the study
18 Years
ALL
No
Sponsors
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Food and Health Bureau, Hong Kong
OTHER_GOV
Chinese University of Hong Kong
OTHER
Responsible Party
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George KC Wong
Clinical Professor
Principal Investigators
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George KC Wong
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Department of Surgery, The Chinese University of Hong Kong
Hong Kong, , China
Countries
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Other Identifiers
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06170516
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GWHMRF2018001
Identifier Type: -
Identifier Source: org_study_id
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