Retrospective Cohort Study of Intracerebral Hemorrhage

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04803292

Acronym

REST

Enrollment

10000

Registered

2021-03-17

Start date

2012-01-01

Completion date

2025-10-01

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactFeng Gao, MD,PhD

2202012@zju.edu.cn13588451471

Backup ContactLusha Tong, MD,PhD

15868171218

Outcome results