NCT06670456
Recruiting
Not Applicable
Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage
De-zhi Kang6 sites in 1 country3,000 target enrollmentNovember 6, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- De-zhi Kang
- Enrollment
- 3000
- Locations
- 6
- Primary Endpoint
- Neurological Function
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.
Investigators
De-zhi Kang
Prof.
First Affiliated Hospital of Fujian Medical University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
- •Underwent no surgical intervention;
Exclusion Criteria
- •Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
- •Pre-stroke life expectancy \< 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure \[NYHA: III-IV\], severe chronic obstructive pulmonary disease \[III-IV\], chronic kidney disease requiring hemodialysis)
- •Severe dependency or incorporation to interview (e.g., pre-stroke mRS\>3, severe dementia, intractable mental disease)
- •Unsuitable for inclusion in the study in the opinion of the investigator
Outcomes
Primary Outcomes
Neurological Function
Time Frame: Discharge; 3, 6, 12 months after enrollment
Assessed with modified Rankin Scale (0-6)
Mortality
Time Frame: Discharge; 3, 6, 12 months after enrollment
Secondary Outcomes
- Complications(Admission period; the 3, 6, 12 months after enrollment)
- Cognitive Status(The 3, 6, 12 months after enrollment)
Study Sites (6)
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