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Prospective Cohort of Patients With Intracerebral Hemorrhage

Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06670456
Enrollment
3000
Registered
2024-11-01
Start date
2023-11-06
Completion date
2028-12-30
Last updated
2024-11-01

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

Conditions

Intracerebral Hemorrhage, Stroke, Acute

Keywords

Intracerebral Hemorrhage

Brief summary

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.

Interventions

None listed

Sponsors

Fuzhou University
CollaboratorOTHER
Fujian Medical University
CollaboratorOTHER
National Institute of Hospital Administration (China)
CollaboratorUNKNOWN
De-zhi Kang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological FunctionDischarge; 3, 6, 12 months after enrollmentAssessed with modified Rankin Scale (0-6)
MortalityDischarge; 3, 6, 12 months after enrollment

Secondary

MeasureTime frameDescription
ComplicationsAdmission period; the 3, 6, 12 months after enrollmentLately stoke, epilepsy, infections, cardiac event, ebolism.
Cognitive StatusThe 3, 6, 12 months after enrollmentAssessed with Telephone Interview for Cognitive Status - Modifed scale (0-51) Chinese version

Countries

China

Contacts

Primary ContactDe-zhi Kang, MD
kdz99988@vip.sina.com86 15759413951
Backup ContactFu-xin Fu-xin, MD
lfxstudy@126.com86 13600893154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026