Cognitive Dysfunction After Aneurysmal Subarachnoid Haemo... | NCT01038193

Studies
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

NCT01038193

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Feb 21, 2024Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Cognitive Dysfunction

Interventions

Cognitive assessment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2009Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 22, 2009

First Posted Date

Dec 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2024

Last Update Posted Date

Feb 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

George KC Wong, Professor (Clinical), Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aSAH patients		Cognitive assessment	Other: Cognitive assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive assessment	Other	Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.	aSAH patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive dysfunction	Montreal Cognitive Assessment	3 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Neurological Outcome	Modified Rankin Scale	3 and 12 months
Generic Quality of Life	ShortForm36(SF-36)	3 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Aneurysmal subarachnoid hemorrhage patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George KC Wong	Division of Neurosurgery, CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Hong Kong	Hong Kong	852	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27165892	Derived	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.
26285662	Derived	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.

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D020300	Intracranial Hemorrhages

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities