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RecruitingNCT04803292RESTUpdated Mar 17, 2021

Retrospective Cohort Study of Intracerebral Hemorrhage

An observational study in Intracerebral Hemorrhage, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2021, 5 years ago, but the record still lists the study as recruiting.
  • Started Jan 2012; still recruiting 14 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2-3years

Secondary outcomes

  1. 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

    Time frame: 2-3years

  2. Relative peripheral hematoma edema(rPHE)

    absolute PHE divided by hematoma volume in CT/MRI

    Time frame: 2-3years

  3. National institute of health stroke scale(NIHSS score)

    NIHSS 0-42, higher indicate worse outcome

    Time frame: 2-3years

07

Study locations

1 of 1 sites recruiting
  • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04803292
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
Jan 1, 2012
Primary completion
Oct 1, 2021 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Mar 17, 2021

Study contacts

Feng Gao, MD,PhD
Contact
2202012@zju.edu.cn
13588451471
Lusha Tong, MD,PhD
Contact
15868171218
Feng Gao, MD,PhD
principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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