Prospective Cohort Study of Intracerebral Hemorrhage

Recruiting

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT04707105
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.

Detailed Description

Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.

Study Timeline

• Study Start: 2020-12-29
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

• Hospitalized patients over 18 years old of primary intracerebral hemorrhage.

Exclusion Criteria

1. patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.
2. isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；
3. surgical evacuation of hematoma；
4. unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
5. patients cannot be followed up for any reasons.
6. patients death in 24 hours
7. pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3	2-3years	mRS 0-6, higher indicate worse outcome

Secondary Outcome Measures

Name	Time	Method
National institute of health stroke scale（NIHSS score）	2-3years	NIHSS 0-42, higher indicate worse outcome
Relative peripheral hematoma edema(rPHE)	2-3years	rPHE：absolute PHE divided by hematoma volume in CT/MRI
Absolute peripheral hematoma edema(PHE) growth	2-3years	absolute peripheral hematoma edema growth in CT/MRI measured by picture archiving and communication systems(PACS) system

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China