An observational study in Intracerebral Hemorrhage, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Xiangya Hospital of Central South University · Observational
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.
CASA is a multicenter, prospective, observational cohort and patient registry coordinated by Xiangya Hospital, Central South University. Consecutive adults with spontaneous intracerebral hemorrhage confirmed by computed tomography and/or magnetic resonance imaging are identified within 30 days after symptom onset. A healthy comparison cohort is recruited from participating health examination programs and communities. The planned sample comprises 10,000 participants with intracerebral hemorrhage and 2,000 healthy controls.
At baseline, trained investigators obtain demographic characteristics, medical and family history, prior medications, vascular risk factors, smoking, alcohol use, dietary and sleep habits, vital signs, neurological severity scores, functional status, laboratory tests, electrocardiography, vascular examinations, treatments, complications, and discharge information. Original computed tomography, computed tomography angiography, magnetic resonance imaging, magnetic resonance angiography, diffusion-weighted imaging, susceptibility-weighted imaging, and digital subtraction angiography are collected when performed as part of clinical care. Imaging is stored in Digital Imaging and Communications in Medicine format. Biospecimens are processed under standardized operating procedures, assigned coded identifiers, and stored centrally for genomic, transcriptomic, proteomic, metabolomic, lipidomic, epigenomic, and other prespecified analyses, within the scope of the ethics-approved consent.
Participants with intracerebral hemorrhage are followed at 3 months, 6 months, and annually from year 1 through year 10. Follow-up records functional outcome using the modified Rankin Scale, recurrent symptomatic intracerebral hemorrhage, and vital status. Outcomes are obtained through clinic review, telephone follow-up, family contact, and linkage to available health insurance and death-registration data. Participants not reached after at least three attempts on different dates in different months within a 12-month period are classified as lost to follow-up after additional tracing efforts.
The primary outcome is the ordinal distribution of modified Rankin Scale scores from 0 (no symptoms) to 6 (death) at 90 days. The key secondary/supportive outcome is 90-day unfavorable functional outcome, defined as mRS 4-6; this binary endpoint is also used in the protocol's minimum sample-size calculation for prognostic modelling. Other secondary analyses evaluate later mRS distributions, all-cause mortality, recurrent symptomatic intracerebral hemorrhage, hematoma expansion, perihematomal edema, and biomarker-outcome associations. Prediction models will be developed using clinical, imaging, and molecular data. Sites in Hunan, Jiangxi, and Hubei provinces are planned as the development cohort, and sites in other provinces as a geographically external evaluation cohort. Model performance will include discrimination, calibration, overall accuracy, and clinical utility.
The registry uses a centralized electronic data capture system, prespecified data definitions, logic and range checks, staff training, source-data review, periodic monitoring, and repeat assessment in a random 3% sample at participating sites. Biospecimen collection, transport, processing, and storage follow harmonized operating procedures with temperature monitoring and chain-of-custody records.
The study began before public registration. This retrospective registration is based on protocol version 1.0 dated 9 December 2023, initially approved on 25 January 2024 (No. 202401026). The original protocol prespecified mRS follow-up and used mRS 4-6 in its prognostic-model sample-size calculation but did not label one outcome as primary. Before PRS submission, the steering committee formalized the 90-day ordinal mRS distribution as the primary outcome and mRS 4-6 at 90 days as the key secondary/supportive outcome. The decision, its date and the absence of outcome-informed changes should be recorded in a signed protocol clarification or statistical analysis plan.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's planned enrollment of 12,000 is above the median of 300 across 180 observational studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria - Intracerebral Hemorrhage Cohort:
Exclusion Criteria - Intracerebral Hemorrhage Cohort:
Inclusion Criteria - Healthy Control Cohort:
Exclusion Criteria - Healthy Control Cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 90 days after intracerebral hemorrhage onset
Unfavorable functional outcome at 90 days
Proportion of participants with an mRS score of 4-6. This key secondary/supportive binary endpoint is used for prognostic-model development and corresponds to the adverse functional outcome used in the protocol's sample-size calculation.
Time frame: 90 days after intracerebral hemorrhage onset
Distribution of modified Rankin Scale scores during longer-term follow-up
Ordinal distribution of mRS scores from 0 (no symptoms) to 6 (death) at each prespecified follow-up.
Time frame: 6 months and annually from year 1 through year 10 after intracerebral hemorrhage onset
All-cause mortality
Death from any cause ascertained by follow-up contact, medical records, and available death-registration or health insurance linkage.
Time frame: From enrollment through 10 years after intracerebral hemorrhage onset
Recurrent symptomatic intracerebral hemorrhage
A new acute neurologic event with new intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and adjudicated according to the study endpoint definition.
Time frame: From enrollment through 10 years after the index intracerebral hemorr
Early hematoma expansion
Increase in intraparenchymal hematoma volume of more than 6 mL or more than 33% from baseline. Participants without an eligible follow-up scan will be reported separately and will not be assumed to have no expansion.
Time frame: Baseline imaging to the first clinically obtained follow-up computed tomography within 72 hours
Change in perihematomal edema volume
Absolute and relative change in segmented perihematomal edema volume between baseline and follow-up imaging.
Time frame: Baseline imaging to follow-up neuroimaging within 72 hours
Area Under the Receiver Operating Characteristic Curve of the Multimodal Model
Discrimination of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as the area under the receiver operating characteristic curve (AUROC) with a 95% confidence interval.
Time frame: 90 days after intracerebral hemorrhage onset
Calibration Intercept of the Multimodal Model
Calibration-in-the-large of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless calibration intercept. An intercept of 0 indicates ideal calibration.
Time frame: 90 days after intracerebral hemorrhage onset
Calibration Slope of the Multimodal Model
Calibration of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless calibration slope. A slope of 1 indicates ideal calibration.
Time frame: 90 days after intracerebral hemorrhage onset
Brier Score of the Multimodal Model
Overall prediction error of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless Brier score ranging from 0 to 1. Lower values indicate better overall predictive accuracy.
Time frame: 90 days after intracerebral hemorrhage onset
Decision-Curve Net Benefit of the Multimodal Model
Clinical utility of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, assessed by decision-curve analysis and reported as unitless net benefit across prespecified probability thresholds. Net benefit will be compared with treat-all and treat-none strategies.
Time frame: 90 days after intracerebral hemorrhage onset
Plan to share: Yes — De-identified individual participant data underlying approved publications, together with a data dictionary, relevant protocol version, and statistical analysis plan, may be shared with qualified researchers following review by the CASA data access committee, execution of a data-use agreement, and confirmation that the proposed use is compatible with participant consent and applicable human genetic resource and data-protection requirements. Biospecimens are not transferred under this IPD plan.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Mar 2029, 61 months after the start.
Of 85 non-industry observational studies under Cerebral Hemorrhage, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 179. This study's planned 61 months is close to that.
Counting every sponsor, half of 87 studies reached it within 62 months; a quarter within 27 and three quarters within 179.
How these figures are worked out, and which studies are left out of them.
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Xiangya Hospital of Central South University →