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NCT Number: NCT03894202

Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, The Chinese University of Hong Kong

Hong Kong, China

About this study

Objectives:

  • To evaluate outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture in Hong Kong;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria for this study are:

  • 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)

The exclusion criteria for this study are:

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

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale

    Time frame: 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 outcomes

  1. Montreal Cognitive Assessment

    Time frame: 1, 3, 6 months

    Montreal Cognitive Assessment (0-30): 0-25 cognitive impairment, 26-30 normal cognition, higher score is better

  2. Stroke-Specific Quality of Life

    Time frame: 1, 3, 6 months

    Minimum is 1, maximum is 5, higher score is better

  3. Short Form-36

    Time frame: 1, 3, 6 months

    Minimum is 0, maximum is 100, higher score is better

  4. Return-to-Work

    Time frame: 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

  5. Hospital Resource Utilization

    Time frame: 6 months

    Hospital Costs in Hong Kong Dollars, minimum is 0, maximum is 10 million, lower cost is better

Other outcomes

  1. Aneurysm ultra-early treatment modality

    Time frame: 6 months

    Modified Rankin Scale in subgroups of Microsurgical Treatment versus Endovascular Treatment, minimum is 0 and maximum is 6 and the lower the better

  2. Neurological Status of Patients underwent Ultra-early Aneurysm Treatment

    Time frame: 6 months

    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

  3. Time of Ultra-early Aneurysm Treatment

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Food and Health Bureau, Hong Kong

Registry information

Official study title

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

Acronym: UEAT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2019
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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