Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracerebral Hemorrhage
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 1374
- Locations
- 1
- Primary Endpoint
- hematoma expansion
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Xingquan Zhao
Professor of Neurology and Stroke Center
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of spontaneous intracerebral hemorrhage(sICH)
- •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
Outcomes
Primary Outcomes
hematoma expansion
Time Frame: 24-48 hours from symptom onset
non-contrast CT scan: the enlargement of hematoma ≥6ml
Functional dependence
Time Frame: 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
Time Frame: 3 months
Death due to one of the following events: ischemic stroke or hemorrhagic stroke
Recurrence of intracerebral hemorrhage
Time Frame: 90 days from symptom onset
non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma
Cardiovascular death
Time Frame: 3 months
Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure
Secondary Outcomes
- New ischemic stroke(3 months)
- New subarachnoid hemorrhage(3 months)
- Other cardiovascular events(3 months)