Prospective Cohort of Patients With Intracerebral Hemorrhage

Recruiting

• Conditions: Stroke, Acute; Intracerebral Hemorrhage

• Registration Number: NCT06670456
• Lead Sponsor: De-zhi Kang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological Function	Discharge; 3, 6, 12 months after enrollment	Assessed with modified Rankin Scale (0-6)
Mortality	Discharge; 3, 6, 12 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Complications	Admission period; the 3, 6, 12 months after enrollment	Lately stoke, epilepsy, infections, cardiac event, ebolism.
Cognitive Status	The 3, 6, 12 months after enrollment	Assessed with Telephone Interview for Cognitive Status - Modifed scale (0-51) Chinese version

Trial Locations

Locations (6)

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Anxi County Hospital; 🇨🇳 Quanzhou, Fujian, China

Jinjiang Municipal Hospital; 🇨🇳 Quanzhou, Fujian, China

The Second Affiliated lospital of Xiamen Medical College; 🇨🇳 Xiamen, Fujian, China

Zhangzhou Municipal Hospital; 🇨🇳 Zhangzhou, Fujian, China

Liaocheng People's Hospital; 🇨🇳 Liaocheng, Shandong, China