Clinical trial NCT06670456: Prospective Cohort of Patients With Intracerebral Hemorrhage
Official title: Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fuzhou University
name: Fujian Medical University
name: National Institute of Hospital Administration (China)
First posted: 2024-11-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were diagnosed with spontaneous intracerebral hemorrhage and received no surgical intervention until enrollment; and those patients should have enough life expectancy and be assessable for the interview, according to their pre-stroke status.

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.


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 \&lt; 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\&gt;3, severe dementia, intractable mental disease)
* Unsuitable for inclusion in the study in the opinion of the investigator

Primary outcomes:
measure: Neurological Function
timeFrame: Discharge; 3, 6, 12 months after enrollment
measure: Mortality
timeFrame: Discharge; 3, 6, 12 months after enrollment
Secondary outcomes:
measure: Complications
timeFrame: Admission period; the 3, 6, 12 months after enrollment
measure: Cognitive Status
timeFrame: The 3, 6, 12 months after enrollment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Anxi County Hospital
state: Fujian
city: Quanzhou
country: China
facility: Jinjiang Municipal Hospital
state: Fujian
city: Xiamen
country: China
facility: The Second Affiliated lospital of Xiamen Medical College
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: De-zhi Kang, MD
role: PRINCIPAL_INVESTIGATOR
References: