Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

Completed

• Conditions: Subarachnoid Hemorrhage

• Registration Number: NCT03894202
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Study Start: 2019-11-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Surgery, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China