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Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH (UEAT)

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ClinicalTrials.gov Identifier: NCT03894202
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong

Study Description
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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.

Condition or disease
Subarachnoid Hemorrhage

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 Design
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Study Type : Observational
Estimated Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Impact of Ultra-Early Aneurysm Treatment on Outcomes in Patients With Poor Neurological Status After Intracranial Aneurysm Rupture
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894202


Contacts
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Contact: Carol MF Chan 35051316 carol@surgery.cuhk.edu.hk

Locations
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China
Department of Surgery, The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: George KC Wong    (852)35052624    georgewong@surgery.cuhk.edu.hk   
Principal Investigator: George KC Wong         
Sponsors and Collaborators
Chinese University of Hong Kong
Food and Health Bureau, Hong Kong
Investigators
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Principal Investigator: George KC Wong Chinese University of Hong Kong
More Information
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Responsible Party: George KC Wong, Clinical Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03894202    
Other Study ID Numbers: GWHMRF2018001
06170516 ( Other Grant/Funding Number: Food and Health Bureau, Hong Kong )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Intracranial Aneurysm
Aneurysm
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
 Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases