Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

NCT ID: NCT03894202

Last Updated: 2023-09-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-03-31

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:

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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Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

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)

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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George KC Wong

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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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