Long Term Outcome After Hemorrhagic Stroke Surgery

Stroke Clinical Trial

Official title:

Long Term Neurological and Cognitive Outcome After Neurosurgical Operation for Hemorrhagic Stroke (Intracerebral Hemorrhage)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409252
• Other study ID #: GW007
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: January 10, 2013
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Stroke

Locations

Country	Name	City	State
China	Department of Surgery, The Chinese University of 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	Modified Rankin Scale		Cross-sectional at 2-12 years after ictus	No
Secondary	Barthel Index	Basic Activity of Daily Living	Cross-sectional at 2-12 years post-ictus	No
Secondary	Telephone Interview of Cognitive Status		Cross-sectional at 2-12 years post-ictus	No