Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

Study Overview
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Brief Summary
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The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

Detailed Description
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This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

Official Title
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Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial

Conditions
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Intracerebral Hemorrhage

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of spontaneous intracerebral hemorrhage(sICH) Age ≥18; Admission within 24 hours of symptom onset CT available at 24 hours Informed consent obtained Exclusion Criteria: Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc. Deep coma at admission (GCS≤8) Intended to have a surgery within 24 hours Congenital coagulation dysfunction Previous intracerebral hematoma have not been absorbed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hematoma Expansion (HE) group<br> | |
| non-HE group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematoma expansion | non-contrast CT scan: the enlargement of hematoma ≥6ml | 24-48 hours from symptom onset | 
| Recurrence of intracerebral hemorrhage | non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma | 90 days from symptom onset | 
| Functional dependence | modified Rankin Scale score ≥3 (a global measure of disability on a seven-level scale, with scores ranging from 0 (no symptoms) to 6 (death), higher scores mean a better or worse outcome ) | 3 months | 
| Cerebrovascular death | Death due to one of the following events: ischemic stroke or hemorrhagic stroke | 3 months | 
| Cardiovascular death | Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New ischemic stroke | Acute focal neurological impairment corresponding with infarction on CT/MR scan | 3 months | 
| New subarachnoid hemorrhage | Hemorrhage in subarachnoid space proven on CT/MR scan | 3 months | 
| Other cardiovascular events | One of the following events: non-fatal myocardial infarction or non-fatal heart failure | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral Hemorrhage, Hematoma Expansion, Artificial Intelligence