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Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03894202
Acronym
UEAT
Enrollment
293
Registered
2019-03-28
Start date
2019-11-01
Completion date
2023-03-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage

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.

Detailed description

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.

Interventions

None listed

Sponsors

Food and Health Bureau, Hong Kong
CollaboratorOTHER_GOV
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale6 monthsModified Rankin Scale (0-6): 0-2 favourable, 3-6 unfavourable, the minimum is 0, the maximum is 6, lower score is better

Secondary

MeasureTime frameDescription
Stroke-Specific Quality of Life1, 3, 6 monthsMinimum is 1, maximum is 5, higher score is better
Short Form-361, 3, 6 monthsMinimum is 0, maximum is 100, higher score is better
Return-to-Work1, 3, 6 monthsReturn 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 Utilization6 monthsHospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better
Montreal Cognitive Assessment1, 3, 6 monthsMontreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better

Other

MeasureTime frameDescription
Time of Ultra-early Aneurysm Treatment6 monthsModified 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
Neurological Status of Patients underwent Ultra-early Aneurysm Treatment6 monthsModified 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
Aneurysm ultra-early treatment modality6 monthsModified Rankin Scale in subgroups of Microsurgical Treatment versus Endovascular Treatment, minimum is 0 and maximum is 6 and the lower the better

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026