Chinese Multicenter Cohort Study of Intracerebral Hemorrhage
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiangya Hospital of Central South University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
12,000 Participants
are grouped into 2 trial groupsGroup A: Spontaneous intracerebral hemorrhage cohort
Group B: Healthy control cohort
Trial outcomes
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.
Time frame
90 days after intracerebral hemorrhage onsetSecondary outcomes
1
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 onset2
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 onset3
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 onset4
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 hemorrSponsors and contacts
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Source ClinicalTrials.gov