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NCT Number: NCT06670456

Prospective Cohort of Patients With Intracerebral Hemorrhage

The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
  • Underwent no surgical intervention;

Exclusion criteria

  • Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
  • Pre-stroke life expectancy < 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure [NYHA: III-IV], severe chronic obstructive pulmonary disease [III-IV], chronic kidney disease requiring hemodialysis)
  • Severe dependency or incorporation to interview (e.g., pre-stroke mRS>3, severe dementia, intractable mental disease)
  • Unsuitable for inclusion in the study in the opinion of the investigator

Treatment and study plan

Primary outcomes

  1. Neurological Function

    Time frame: Discharge; 3, 6, 12 months after enrollment

    Assessed with modified Rankin Scale (0-6)

  2. Mortality

    Time frame: Discharge; 3, 6, 12 months after enrollment

Secondary outcomes

  1. Complications

    Time frame: Admission period; the 3, 6, 12 months after enrollment

    Lately stoke, epilepsy, infections, cardiac event, ebolism.

  2. Cognitive Status

    Time frame: The 3, 6, 12 months after enrollment

    Assessed with Telephone Interview for Cognitive Status - Modifed scale (0-51) Chinese version

Study contacts

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

De-zhi Kang, MD

CONTACT

[email protected]

86 15759413951

Fu-xin Fu-xin, MD

CONTACT

[email protected]

86 13600893154

Sponsors and collaborators

Lead sponsor

De-zhi Kang

Other

Collaborators

  • Fujian Medical University
  • Fuzhou University
  • National Institute of Hospital Administration (China)

Registry information

Official study title

Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

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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