Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

Subarachnoid Hemorrhage Clinical Trial

— UEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894202
• Other study ID #: GWHMRF2018001
• Secondary ID: 06170516
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
China	Department of Surgery, The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aneurysm ultra-early treatment modality	Modified Rankin Scale in subgroups of Microsurgical Treatment versus Endovascular Treatment, minimum is 0 and maximum is 6 and the lower the better	6 months
Other	Neurological Status of Patients underwent Ultra-early Aneurysm Treatment	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	6 months
Other	Time of Ultra-early Aneurysm Treatment	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	6 months
Primary	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	6 months
Secondary	Montreal Cognitive Assessment	Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better	1, 3, 6 months
Secondary	Stroke-Specific Quality of Life	Minimum is 1, maximum is 5, higher score is better	1, 3, 6 months
Secondary	Short Form-36	Minimum is 0, maximum is 100, higher score is better	1, 3, 6 months
Secondary	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	1, 3, 6 months
Secondary	Hospital Resource Utilization	Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better	6 months