Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

Chinese University of Hong Kong293 enrolled

Overview

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.

Objectives: 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.

Study Type

OBSERVATIONAL

Enrollment

293

Conditions

Subarachnoid Hemorrhage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

The inclusion criteria for this study are: 1. Adult patients (aged \>18 years) with spontaneous subarachnoid hemorrhage 2. Admission into Hospital Authority neurosurgical services 3. The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5) The exclusion criteria for this study are: 1. Patients are likely to leave Hong Kong shortly after episode 2. Patients (or next-of-kin as appropriate) refuse to participate into the study

Locations (1)

Department of Surgery, The Chinese University of Hong Kong

Hong Kong, China

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Montreal Cognitive Assessment

Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better

Time frame: 1, 3, 6 months

Stroke-Specific Quality of Life

Minimum is 1, maximum is 5, higher score is better

Time frame: 1, 3, 6 months

Short Form-36

Minimum is 0, maximum is 100, higher score is better

Time frame: 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

Time frame: 1, 3, 6 months

Hospital Resource Utilization

Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better

Time frame: 6 months

Data from ClinicalTrials.gov

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