Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

NCT03894202 | Completed

• 2 other identifiers: GWHMRF201800106170516
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Montreal Cognitive Assessment

  1, 3, 6 months

• Stroke-Specific Quality of Life

  1, 3, 6 months

• Short Form-36

  1, 3, 6 months

• Return-to-Work

  1, 3, 6 months

• Hospital Resource Utilization

  6 months

Other Outcomes (3)

• Aneurysm ultra-early treatment modality

  6 months

• Neurological Status of Patients underwent Ultra-early Aneurysm Treatment

  6 months

• Time of Ultra-early Aneurysm Treatment

  6 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult patients (aged \>18 years) with spontaneous subarachnoid hemorrhage
• Admission into Hospital Authority neurosurgical services
• The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5)

You may not qualify if:

• Patients are likely to leave Hong Kong shortly after episode
• Patients (or next-of-kin as appropriate) refuse to participate into the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (1)

Department of Surgery, The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George KC Wong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: November 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)