Retrospective Cohort Study of Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

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Official title:

A Retrospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803292
• Other study ID #: I20200011153
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Feng Gao, MD,PhD
• Phone: 13588451471
• Email: 2202012[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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. unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI

4. patients cannot be followed up for any reasons.

5. patients death in 24 hours

6. pregnant patients

7. surgical evacuation of hematoma

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a 3-month modified Rankin Scale (mRS) score= 3 proportion of patients with a 3-month modified Rankin Scale (mRS) score= 3 proportion of patients with a 3-month modified Rankin Scale (mRS) score= 3	mRS 0-6, higher indicate worse outcome	2-3years
Secondary	Absolute peripheral hematoma edema(PHE) growth	absolute peripheral hematoma edema growth in CT/MRI measured by picture archiving and communication systems(PACS) system; absolute peripheral hematoma edema growth in CT/MRI measured by PACS system	2-3years
Secondary	Relative peripheral hematoma edema(rPHE)	absolute PHE divided by hematoma volume in CT/MRI	2-3years
Secondary	National institute of health stroke scale(NIHSS score)	NIHSS 0-42, higher indicate worse outcome	2-3years