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Clinical Trials/NCT06670456
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.

Registry
clinicaltrials.gov
Start Date
November 6, 2023
End Date
December 30, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
De-zhi Kang
Responsible Party
Sponsor Investigator
Principal Investigator

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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