NCT01038193

Brief Summary

This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

14.7 years

First QC Date

December 22, 2009

Last Update Submit

February 19, 2024

Conditions

Keywords

Cognition, subarachnoid hemorrhage.

Outcome Measures

Primary Outcomes (1)

  • Cognitive dysfunction

    Montreal Cognitive Assessment

    3 and 12 months

Secondary Outcomes (5)

  • Neurological Outcome

    3 and 12 months

  • Generic Quality of Life

    3 and 12 months

  • Activity of Daily Living

    3 and 12 months

  • Disease-specific Quality of Life

    3 and 12 months

  • Functional Outcome

    3 and 12 months

Study Arms (1)

aSAH patients

Cognitive assessment

Other: Cognitive assessment

Interventions

Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.

Also known as: Cognition
aSAH patients

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aneurysmal subarachnoid hemorrhage patients

You may qualify if:

  • Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology
  • Admission within 96 hours of ictus
  • Aged between 21 and 75 years
  • A speaker of Chinese (Mandarin or Cantonese)
  • Informed consent from patients or their legally acceptable representatives

You may not qualify if:

  • History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm
  • History of neurosurgical operation prior to ictus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, 852, China

Location

Related Publications (9)

  • Wong GK, Lam SW, Wong A, Ngai K, Mok V, Poon WS. Early Cognitive Domain Deficits in Patients with Aneurysmal Subarachnoid Hemorrhage Correlate with Functional Status. Acta Neurochir Suppl. 2016;122:129-32. doi: 10.1007/978-3-319-22533-3_26.

  • Wong GK, Wong A, Zee BC, Poon WS, Chan MT, Gin T, Siu DY, Mok VC. Cognitive outcome in acute simvastatin treatment for aneurysmal subarachnoid hemorrhage: A propensity matched analysis. J Neurol Sci. 2015 Nov 15;358(1-2):58-61. doi: 10.1016/j.jns.2015.08.013. Epub 2015 Aug 12.

  • Chu AC, Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Cognitive impairment in aneurysmal subarachnoid hemorrhage patients with delayed cerebral infarction: prevalence and pattern. Acta Neurochir Suppl. 2015;120:303-6. doi: 10.1007/978-3-319-04981-6_51.

  • Wong GK, Lam SW, Wong A, Lai M, Siu D, Poon WS, Mok V. MoCA-assessed cognitive function and excellent outcome after aneurysmal subarachnoid hemorrhage at 1 year. Eur J Neurol. 2014 May;21(5):725-30. doi: 10.1111/ene.12363. Epub 2014 Jan 28.

  • Wong GK, Lam SW, Wong A, Mok V, Siu D, Ngai K, Poon WS. Early MoCA-assessed cognitive impairment after aneurysmal subarachnoid hemorrhage and relationship to 1-year functional outcome. Transl Stroke Res. 2014 Apr;5(2):286-91. doi: 10.1007/s12975-013-0284-z. Epub 2013 Sep 7.

  • Wong GK, Lam SW, Ngai K, Wong A, Poon WS, Mok V. Development of a short form of Stroke-Specific Quality of Life Scale for patients after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2013 Dec 15;335(1-2):204-9. doi: 10.1016/j.jns.2013.09.033. Epub 2013 Oct 2.

  • Wong GK, Lam SW, Ngai K, Wong A, Siu D, Poon WS, Mok V; Cognitive Dysfunction after Aneurysmal Subarachnoid Hemorrhage Investigators. Cognitive domain deficits in patients with aneurysmal subarachnoid haemorrhage at 1 year. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1054-8. doi: 10.1136/jnnp-2012-304517. Epub 2013 Apr 20.

  • Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Comparison of montreal cognitive assessment and mini-mental state examination in evaluating cognitive domain deficit following aneurysmal subarachnoid haemorrhage. PLoS One. 2013;8(4):e59946. doi: 10.1371/journal.pone.0059946. Epub 2013 Apr 3.

  • Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.

MeSH Terms

Conditions

Cognitive DysfunctionSubarachnoid Hemorrhage

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • George KC Wong

    Division of Neurosurgery, CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Clinical)

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

March 1, 2009

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations