Prospective Cohort of Patients With Intracerebral Hemorrhage

NCT06670456 | Recruiting

• 1 other identifier: 2022ZD01003
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke, Acute; Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Neurological Function

  Assessed with modified Rankin Scale (0-6)

  Discharge; 3, 6, 12 months after enrollment

• Mortality

  Discharge; 3, 6, 12 months after enrollment

Secondary Outcomes (2)

• Complications

  Admission period; the 3, 6, 12 months after enrollment

• Cognitive Status

  The 3, 6, 12 months after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
• Underwent no surgical intervention;

You may not qualify if:

• 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)

Sponsors & Collaborators

• De-zhi Kang: lead
• Fuzhou University: collaborator
• Fujian Medical University: collaborator
• National Institute of Hospital Administration (China): collaborator

Study Sites (6)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, 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

Biospecimen

Retention: SAMPLES WITH DNA

1\. Peripheral blood; 2. Cerebrospinal fluid; 3. Evacuated hematoma, cerebral tissue, and/or bone flap. (No for everyone)

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• De-zhi Kang, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

De-zhi Kang, MD

CONTACT

86 15759413951; kdz99988@vip.sina.com

Fu-xin Fu-xin, MD

CONTACT

86 13600893154; lfxstudy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 6, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (6)