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Long Term Outcome After Hemorrhagic Stroke Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01409252
First received: August 3, 2011
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then telephoned the survivors for neurological and cognitive status.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Neurological and Cognitive Outcome After Neurosurgical Operation for Hemorrhagic Stroke (Intracerebral Hemorrhage)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: Cross-sectional at 2-12 years after ictus ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Barthel Index [ Time Frame: Cross-sectional at 2-12 years post-ictus ] [ Designated as safety issue: No ]
    Basic Activity of Daily Living

  • Telephone Interview of Cognitive Status [ Time Frame: Cross-sectional at 2-12 years post-ictus ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemorrhagic stroke patients

Detailed Description:

Death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. Of patients who had intracerebral hemorrhage in the United States during 2002, only 20% are expected to be functionally independently at 6 months. Although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. With these in mind, we carried out this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Spontaneous intracerebral hemorrhage with neurosurgical operations

Criteria

Inclusion Criteria:

  • All hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008.

Exclusion Criteria:

  • Spontaneous subarachnoid hemorrhage as the dominant etiology
  • uncommunicable patients
  • nonsurvivors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409252

Locations
China
Department of Surgery, The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: George Wong, MD(CUHK) FRCSEd(SN) Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01409252     History of Changes
Other Study ID Numbers: GW007
Study First Received: August 3, 2011
Last Updated: January 10, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Stroke
intracerebral hemorrhage
surgery

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Cerebral Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013