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Recruiting NCT04707105

Prospective Cohort Study of Intracerebral Hemorrhage

Observational Intracerebral Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracerebral Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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.

Primary outcome measures

  • proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3 [Time frame: 2-3years]
Secondary outcome measures (3)
  • Absolute peripheral hematoma edema(PHE) growth [Time frame: 2-3years]
  • Relative peripheral hematoma edema(rPHE) [Time frame: 2-3years]
  • National institute of health stroke scale(NIHSS score) [Time frame: 2-3years]

Eligibility criteria

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;
  • surgical evacuation of hematoma;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • 2nd Affiliated Hospital, School of Medicine at Zhejiang University — Hangzhou

Identifiers

NCT: NCT04707105 · I2018001098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗