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Recruiting NCT07833410

Chinese Multicenter Cohort Study of Intracerebral Hemorrhage

Conditions: Intracerebral Hemorrhage

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 12000
Sponsor: Xiangya Hospital of Central South University

Location: Xiangya Hospital, Central South University Changsha Hunan

Summary

Spontaneous intracerebral hemorrhage is a severe form of stroke associated with high mortality and long-term disability. The Chinese Multicenter Cohort Study of Intracerebral Hemorrhage (CASA) is a prospective observational patient registry designed to enroll approximately 10,000 adults with imaging-confirmed spontaneous intracerebral hemorrhage and 2,000 adult healthy controls at more than 30 hospitals in China. The study will collect standardized clinical, laboratory, neuroimaging, lifestyle, and treatment data together with ethically approved blood, urine, and other biospecimens. Participants with intracerebral hemorrhage will be followed at 3 months, 6 months, and annually for up to 10 years. The primary objective is to characterize and identify determinants of the full distribution of modified Rankin Scale scores at 90 days. Secondary objectives include evaluating 90-day unfavorable functional outcome defined as mRS 4-6, recurrent intracerebral hemorrhage and mortality, identifying clinical and molecular biomarkers, and developing and externally evaluating multimodal prognostic models. The study does not assign treatment; all clinical care is determined by treating clinicians.

Eligibility Criteria

Inclusion Criteria - Intracerebral Hemorrhage Cohort: * Age 18 years or older. * Intracerebral hemorrhage confirmed by head computed tomography and/or magnetic resonance imaging. * Hemorrhage located in a deep cerebral region, cerebral lobe, cerebellum, or brainstem. * Presentation to a participating hospital within 30 days after symptom onset. * Written informed consent and broad consent provided in accordance with the ethics-approved process. Exclusion Criteria - Intracerebral Hemorrhage Cohort: * Traumatic intracerebral hemorrhage. * Secondary intracerebral hemorrhage attributed to an arteriovenous malformation, ruptured aneurysm, moyamoya disease, cavernous malformation, hematologic disorder, hemorrhagic tumor, vasculitis, cerebral venous thrombosis, hemorrhagic transformation of cerebral infarction, or other prespecified secondary cause. * Mixed intracerebral hemorrhage involving multiple deep and lobar locations at onset. * Severe psychiatric disease that precludes study procedures or follow-up. * End-stage hepatic or renal failure. * Autoimmune disease judged by the investigator to materially affect study objectives. * Active malignant tumor. * Pregnancy. * Any other condition that the investigator judges makes participation inappropriate. Inclusion Criteria - Healthy Control Cohort: * Age 18 years or older. * Able to provide written informed consent. * No known history of intracerebral hemorrhage. Exclusion Criteria - Healthy Control Cohort: * Malignant tumor. * Neurologic disease, particularly any prior intracerebral hemorrhage. * Any other condition that the investigator judges makes participation inappropriate.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07833410). StuddyBuddy aggregates publicly available trial information.