Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

Beijing Tiantan Hospital1,374 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,374

Conditions

Intracerebral Hemorrhage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Tiantan Hospital

Beijing, China

Outcomes

Primary Outcomes

hematoma expansion

non-contrast CT scan: the enlargement of hematoma ≥6ml

Time frame: 24-48 hours from symptom onset

Recurrence of intracerebral hemorrhage

non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma

Time frame: 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 )

Time frame: 3 months

Cerebrovascular death

Death due to one of the following events: ischemic stroke or hemorrhagic stroke

Time frame: 3 months

Cardiovascular death

Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure

Time frame: 3 months

Secondary Outcomes

New ischemic stroke

Acute focal neurological impairment corresponding with infarction on CT/MR scan

Time frame: 3 months

New subarachnoid hemorrhage

Hemorrhage in subarachnoid space proven on CT/MR scan

Time frame: 3 months

Other cardiovascular events

One of the following events: non-fatal myocardial infarction or non-fatal heart failure

Data from ClinicalTrials.gov

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