Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

Completed

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT04951570
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-20
• Study Start: 2021-06-23
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-07
• Status Verified: 2023-02
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1374

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hematoma expansion	24-48 hours from symptom onset	non-contrast CT scan: the enlargement of hematoma ≥6ml
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
Recurrence of intracerebral hemorrhage	90 days from symptom onset	non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma
Cardiovascular death	3 months	Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure

Secondary Outcome Measures

Name	Time	Method
New ischemic stroke	3 months	Acute focal neurological impairment corresponding with infarction on CT/MR scan
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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China