Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Cognitive Dysfunction Clinical Trial

Official title:

Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038193
• Other study ID #: GW004
• Status: Completed
• Start date: March 1, 2009
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion criteria

1. Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology

2. Admission within 96 hours of ictus

3. Aged between 21 and 75 years

4. A speaker of Chinese (Mandarin or Cantonese)

5. Informed consent from patients or their legally acceptable representatives Exclusion criteria

1. History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm

2. History of neurosurgical operation prior to ictus

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Cognitive assessment
Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive dysfunction	Montreal Cognitive Assessment	3 and 12 months
Secondary	Neurological Outcome	Modified Rankin Scale	3 and 12 months
Secondary	Generic Quality of Life	ShortForm36(SF-36)	3 and 12 months
Secondary	Activity of Daily Living	Barthel Index	3 and 12 months
Secondary	Disease-specific Quality of Life	Stroke-specific-QOL	3 and 12 months
Secondary	Functional Outcome	Functional Independent Measure (FIM)	3 and 12 months