Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral Hemorrhage, Hematoma Expansion, Artificial Intelligence
Brief summary
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
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.
Interventions
None listed
Sponsors
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Diagnosis of spontaneous intracerebral hemorrhage(sICH) 2. Age ≥18; 3. Admission within 24 hours of symptom onset 4. CT available at 24 hours 5. Informed consent obtained
Exclusion criteria
1. Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc. 2. Deep coma at admission (GCS≤8) 3. Intended to have a surgery within 24 hours 4. Congenital coagulation dysfunction 5. Previous intracerebral hematoma have not been absorbed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | 3 months | Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure |
| Recurrence of intracerebral hemorrhage | 90 days from symptom onset | non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma |
| Functional dependence | 3 months | 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 ) |
| Cerebrovascular death | 3 months | Death due to one of the following events: ischemic stroke or hemorrhagic stroke |
| hematoma expansion | 24-48 hours from symptom onset | non-contrast CT scan: the enlargement of hematoma ≥6ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New subarachnoid hemorrhage | 3 months | Hemorrhage in subarachnoid space proven on CT/MR scan |
| Other cardiovascular events | 3 months | One of the following events: non-fatal myocardial infarction or non-fatal heart failure |
| New ischemic stroke | 3 months | Acute focal neurological impairment corresponding with infarction on CT/MR scan |
Countries
China
Outcome results
None listed