Clinical trial NCT03894202: Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH
Official title: Assessment of the Impact of Ultra-Early Aneurysm Treatment on Outcomes in Patients With Poor Neurological Status After Intracranial Aneurysm Rupture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2019-03-28
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial aneurysm rupture (aneurysmal subarachnoid hemorrhage/SAH) admitted to seven public neurosurgical services in 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.

Eligibility 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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 6 months
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 1, 3, 6 months
measure: Stroke-Specific Quality of Life
timeFrame: 1, 3, 6 months
measure: Short Form-36
timeFrame: 1, 3, 6 months
measure: Return-to-Work
timeFrame: 1, 3, 6 months
measure: Hospital Resource Utilization
timeFrame: 6 months
Other outcomes:
measure: Aneurysm ultra-early treatment modality
timeFrame: 6 months
measure: Neurological Status of Patients underwent Ultra-early Aneurysm Treatment
timeFrame: 6 months
measure: Time of Ultra-early Aneurysm Treatment
timeFrame: 6 months
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: George KC Wong
role: PRINCIPAL_INVESTIGATOR
References: