Clinical trial NCT04803292: Retrospective Cohort Study of Intracerebral Hemorrhage
Official title: A Retrospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Keywords: primary intracerebral hemorrhage
hypertension
perihematomal edema
secondary brain injury
remote diffusion-weighted imaging lesions(R-DWILs)
immune response
multimodel image
cohort
MRI
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2-3years
Secondary outcomes:
measure: Absolute peripheral hematoma edema(PHE) growth
timeFrame: 2-3years
measure: Relative peripheral hematoma edema(rPHE)
timeFrame: 2-3years
measure: National institute of health stroke scale（NIHSS score）
timeFrame: 2-3years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Feng Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: