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NCT Number: NCT04707105

Prospective Cohort Study of Intracerebral Hemorrhage

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Hypertension Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Feng Gao, MD,PhD

CONTACT

[email protected]

13588451471

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3

    Time frame: 2-3years

    mRS 0-6, higher indicate worse outcome

Secondary outcomes

  1. Absolute peripheral hematoma edema(PHE) growth

    Time frame: 2-3years

    absolute peripheral hematoma edema growth in CT/MRI measured by picture archiving and communication systems(PACS) system

  2. Relative peripheral hematoma edema(rPHE)

    Time frame: 2-3years

    rPHE：absolute PHE divided by hematoma volume in CT/MRI

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

    Time frame: 2-3years

    NIHSS 0-42, higher indicate worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Gao, MD,PhD

CONTACT

[email protected]

13588451471

Lusha Tong, MD,PhD

CONTACT

15868171218

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: POSTER

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2021
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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