Chinese Multicenter Cohort Study of Intracerebral Hemorrhage

NCT07833410 | Recruiting

• 3 other identifiers: 2024010262024-CJ01052025PT5001
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

Spontaneous intracerebral hemorrhage; Hemorrhagic stroke; Prospective cohort; Hematoma expansion; Perihematomal edema; Functional outcome; Biomarker; Genomics; Multi-omics; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Distribution of modified Rankin Scale scores at 90 day

  Ordinal distribution of modified Rankin Scale scores among participants with intracerebral hemorrhage. The scale ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse functional outcome. The primary analysis uses all seven ordered categories rather than dichotomizing the scale.

  90 days after intracerebral hemorrhage onset

Secondary Outcomes (11)

• Unfavorable functional outcome at 90 days

  90 days after intracerebral hemorrhage onset

• Distribution of modified Rankin Scale scores during longer-term follow-up

  6 months and annually from year 1 through year 10 after intracerebral hemorrhage onset

• All-cause mortality

  From enrollment through 10 years after intracerebral hemorrhage onset

• Recurrent symptomatic intracerebral hemorrhage

  From enrollment through 10 years after the index intracerebral hemorr

• Early hematoma expansion

  Baseline imaging to the first clinically obtained follow-up computed tomography within 72 hours

Study Arms (2)

Spontaneous intracerebral hemorrhage cohort

Approximately 10,000 adults with spontaneous intracerebral hemorrhage confirmed by computed tomography and/or magnetic resonance imaging, enrolled within 30 days after symptom onset at participating hospitals. Participants receive usual care determined by treating clinicians and undergo standardized baseline assessment, collection of approved biospecimens, and longitudinal follow-up.

Healthy control cohort

Approximately 2,000 adults without a history of intracerebral hemorrhage or other neurologic disease, recruited from participating health examination programs or communities. Controls undergo standardized baseline assessment and collection of approved biospecimens; no study-assigned treatment is provided.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with imaging-confirmed spontaneous intracerebral hemorrhage presenting within 30 days after symptom onset to more than 30 participating hospitals in China are recruited consecutively. Adult healthy controls without neurologic disease are recruited from participating health examination programs and communities. The coordinating center is Xiangya Hospital, Central South University, Changsha, China.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Age 18 years or older.
• Able to provide written informed consent.
• No known history of intracerebral hemorrhage.
• Malignant tumor.
• Neurologic disease, particularly any prior intracerebral hemorrhage.
• Any other condition that the investigator judges makes participation inappropriate.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Ethics-approved peripheral blood fractions for DNA, RNA, serum, and plasma; midstream urine; and optional stool are collected, processed, aliquoted, coded, transported under monitored temperature conditions, and stored at the Xiangya Hospital biobank. Planned uses include genomic, epigenomic, transcriptomic, proteomic, metabolomic, lipidomic, microbiome, and targeted biomarker analyses. Collection volumes and specimen types will not exceed the current ethics-approved informed-consent form at each site.

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Le Zhang, Professor, MD

CONTACT

+86 178 7316 7010; zlzdzlzd@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 22, 2026
• Study Start: February 1, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2039
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 24 months after publication of each prespecified primary analysis and available for 5 years, subject to continuing legal, ethical, and institutional permissions.
• Access Criteria: Requests must include a scientifically sound proposal, analysis plan, investigator qualifications, evidence of ethics approval or exemption, data security arrangements, and a publication plan. Approval by the CASA steering committee and institutional data governance bodies, plus a signed data-use agreement, is required. Access may be restricted when consent, privacy, human genetic resource rules, contractual obligations, or ongoing analyses prevent sharing.

Locations

CN (1)