UEAT: Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
|
| 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. |
Outcome Measures
Primary Outcome Measures
- Modified Rankin Scale [6 months]
Modified Rankin Scale (0-6): 0-2 favourable, 3-6 unfavourable, the minimum is 0, the maximum is 6, lower score is better
Secondary Outcome Measures
- Montreal Cognitive Assessment [1, 3, 6 months]
Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better
- Stroke-Specific Quality of Life [1, 3, 6 months]
Minimum is 1, maximum is 5, higher score is better
- Short Form-36 [1, 3, 6 months]
Minimum is 0, maximum is 100, higher score is better
- Return-to-Work [1, 3, 6 months]
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
- Hospital Resource Utilization [6 months]
Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better
Other Outcome Measures
- Aneurysm ultra-early treatment modality [6 months]
Modified Rankin Scale in subgroups of Microsurgical Treatment versus Endovascular Treatment, minimum is 0 and maximum is 6 and the lower the better
- Neurological Status of Patients underwent Ultra-early Aneurysm Treatment [6 months]
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
- Time of Ultra-early Aneurysm Treatment [6 months]
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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, The Chinese University of Hong Kong | Hong Kong | China |
Sponsors and Collaborators
- Chinese University of Hong Kong
- Food and Health Bureau, Hong Kong
Investigators
- Principal Investigator: George KC Wong, Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GWHMRF2018001
- 06170516