REST: Retrospective Cohort Study of Intracerebral Hemorrhage

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04803292

Collaborator

(none)

10,000

Enrollment

Location

165

Anticipated Duration (Months)

60.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Second Affiliated Hospital, School of Medicine, Zhejiang University a prospective cohort of patients of primary intracerebral hemorrhage in Second Affiliated Hospital, School of Medicine, Zhejiang University
Second People's Hospital of Hangzhou City, Zhejiang Province a prospective cohort of patients of primary intracerebral hemorrhage in Second People's Hospital of Hangzhou City, Zhejiang Province
4th Affiliated Hospital, School of Medicine at Zhejiang University a prospective cohort of patients of primary intracerebral hemorrhage in 4th Affiliated Hospital, School of Medicine at Zhejiang University

Outcome Measures

Primary Outcome Measures

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 [2-3years]
mRS 0-6, higher indicate worse outcome

Secondary Outcome Measures

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 absolute peripheral hematoma edema growth in CT/MRI measured by PACS system
Relative peripheral hematoma edema(rPHE) [2-3years]
absolute PHE divided by hematoma volume in CT/MRI
National institute of health stroke scale（NIHSS score） [2-3years]
NIHSS 0-42, higher indicate worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hospitalized patients over 18 years old of primary intracerebral hemorrhage.

Exclusion Criteria:

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