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Long Term Outcome After Hemorrhagic Stroke Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409252
First Posted: August 4, 2011
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
  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:


Further study details as provided by George KC Wong, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: Cross-sectional at 2-12 years after ictus ]

Secondary Outcome Measures:
  • Barthel Index [ Time Frame: Cross-sectional at 2-12 years post-ictus ]
    Basic Activity of Daily Living

  • Telephone Interview of Cognitive Status [ Time Frame: Cross-sectional at 2-12 years post-ictus ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01409252     History of Changes
Other Study ID Numbers: GW007
First Submitted: August 3, 2011
First Posted: August 4, 2011
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by George KC Wong, Chinese University of Hong Kong:
Stroke
intracerebral hemorrhage
surgery

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