- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409252
Long Term Outcome After Hemorrhagic Stroke Surgery
January 10, 2013 updated by: George KC Wong, Chinese University of Hong Kong
Long Term Neurological and Cognitive Outcome After Neurosurgical Operation for Hemorrhagic Stroke (Intracerebral Hemorrhage)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
191
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Department of Surgery, The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Spontaneous intracerebral hemorrhage with neurosurgical operations
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Hemorrhagic stroke patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Modified Rankin Scale
Time Frame: Cross-sectional at 2-12 years after ictus
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Cross-sectional at 2-12 years after ictus
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Barthel Index
Time Frame: Cross-sectional at 2-12 years post-ictus
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Basic Activity of Daily Living
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Cross-sectional at 2-12 years post-ictus
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Telephone Interview of Cognitive Status
Time Frame: Cross-sectional at 2-12 years post-ictus
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Cross-sectional at 2-12 years post-ictus
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: George Wong, MD(CUHK) FRCSEd(SN), Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 3, 2011
First Submitted That Met QC Criteria
August 3, 2011
First Posted (Estimate)
August 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 14, 2013
Last Update Submitted That Met QC Criteria
January 10, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GW007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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