Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

Study Overview
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Brief Summary
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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.

Detailed Description
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Objectives: To evaluate outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture in Hong Kong; 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.

Official Title
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Assessment of the Impact of Ultra-Early Aneurysm Treatment on Outcomes in Patients With Poor Neurological Status After Intracranial Aneurysm Rupture

Conditions
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Subarachnoid Hemorrhage

Participation Criteria
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Eligibility Criteria
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The inclusion criteria for this study are: Adult patients (aged >18 years) with spontaneous subarachnoid hemorrhage Admission into Hospital Authority neurosurgical services The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5) The exclusion criteria for this study are: Patients are likely to leave Hong Kong shortly after episode Patients (or next-of-kin as appropriate) refuse to participate into the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultra-early aneurysm treatment<br>Ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping within the initial twenty-four hours. | |
| Non-ultra-early aneurysm treatment<br>Non-ultra-early aneurysm treatment is defined as definitive cerebral aneurysm treatment such as coiling or clipping after the initial twenty-four hours. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | Modified Rankin Scale (0-6): 0-2 favourable, 3-6 unfavourable, the minimum is 0, the maximum is 6, lower score is better | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better | 1, 3, 6 months | 
| Stroke-Specific Quality of Life | Minimum is 1, maximum is 5, higher score is better | 1, 3, 6 months | 
| Short Form-36 | Minimum is 0, maximum is 100, higher score is better | 1, 3, 6 months | 
| Return-to-Work | 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 | 1, 3, 6 months | 
| Hospital Resource Utilization | Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better | 6 months |