Observational study of patients with spontaneous intracerebral hemorrhage

Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage

This study is looking at patients with spontaneous brain bleeding to see how they recover and what long-term effects they might have.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (Academic / other)
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT06670456 on ClinicalTrials.gov

What this trial studies

This multicentral, observational, prospective cohort study aims to gather data on patients diagnosed with spontaneous intracerebral hemorrhage (ICH) to assess early outcomes, complications, and long-term neurological and cognitive function. The study will include patients who have not undergone surgical intervention and will analyze cortical data for risk stratification and biomarkers. By following these patients over time, the study seeks to provide insights into the progression and recovery from ICH.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with spontaneous intracerebral hemorrhage who have not had any surgical interventions.

Not a fit: Patients with secondary intracerebral hemorrhage or severe comorbidities that limit life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of ICH outcomes and lead to better risk stratification and management strategies for patients.

How similar studies have performed: While observational studies on ICH exist, this specific approach focusing on cortical data and long-term outcomes is relatively novel.

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

Where this trial is running

Fuzhou, Fujian and 5 other locations

• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Anxi County Hospital — Quanzhou, Fujian, China (Recruiting)
• Jinjiang Municipal Hospital — Quanzhou, Fujian, China (Recruiting)
• The Second Affiliated lospital of Xiamen Medical College — Xiamen, Fujian, China (Recruiting)
• Zhangzhou Municipal Hospital — Zhangzhou, Fujian, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)

Study contacts

• Principal investigator: De-zhi Kang, MD — First Affiliated Hospital of Fujian Medical University
• Study coordinator: De-zhi Kang, MD

Conditions Stroke, Acute; Intracerebral Hemorrhage