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Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01038193
First received: December 22, 2009
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Condition Intervention
Cognitive Dysfunction
Other: Cognitive assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Cognitive dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • ShortForm36(SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lawton-Instrumental-ActivityOfDailyLiving(IADL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stroke-specific-QOL [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
aSAH patients
Cognitive assessment
Other: Cognitive assessment
Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.
Other Name: Cognition

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.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Aneurysmal subarachnoid hemorrhage patients
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038193

Contacts
Contact: George KC Wong (852) 26321316
Contact: Shirley Chiu (852) 26322624

Locations
China, Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China, 852
Contact: George KC Wong    (852)26322624      
Contact: Shirley Chiu    (852)26321316      
Principal Investigator: George KC Wong         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: George KC Wong Division of Neurosurgery, CUHK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01038193     History of Changes
Other Study ID Numbers: GW004 
Study First Received: December 22, 2009
Last Updated: April 21, 2016
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Chinese University of Hong Kong:
Cognition, subarachnoid hemorrhage.

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Cognition Disorders
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 08, 2016