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Clinical Outcomes Following Primary Intracerebral Hemorrhage

Clinical Outcomes Following Primary Intracerebral Hemorrhage:A Multicenter Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06548737
Acronym
COPI
Enrollment
25000
Registered
2024-08-12
Start date
2016-10-27
Completion date
2033-12-31
Last updated
2024-08-12

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

Conditions

Intracerebral Hemorrhage, Stroke

Keywords

Primary intracerebral hemorrhage, Stroke, Outcomes

Brief summary

The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage.

Detailed description

This cohort was an analysis based on patients from six stroke centers: the 2nd Affiliated Hospital of Zhejiang University; the First People's Hospital of Pinghu, Jiaxing; the First People's Hospital of Taizhou; the People's Hospital of Haiyan, Jiaxing; Tiantai County People's Hospital, Taizhou; the 2nd People's Hospital of Quzhou (Please see more information of this cohort in supplement). All hospitals are located in Zhejiang Province. Patients' data were entered by local trained registrars using standardised protocols, and the overall process of case registration, monitoring of the data quality, and inquiry and correction of erroneous data was managed and supervised by a steering committee. We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS \>2 before the current ICH episode (according to past medical records or description from guardians. This study was approved by human research ethic committees at all participating centers, and conducted in compliance with the principles set forward by the Declaration of Helsinki.

Interventions

None listed

Sponsors

The People's Hospital of Haiyan
CollaboratorUNKNOWN
Taizhou First People's Hospital
CollaboratorOTHER
The First People's Hospital of Pinghu
CollaboratorUNKNOWN
The 2nd People's Hospital of Quzhou
CollaboratorUNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

\- We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures.

Exclusion criteria

* We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS \>2 before the current ICH episode (according to past medical records or description from guardians.

Design outcomes

Primary

MeasureTime frameDescription
All-cause death5 years after ICHPatients die of any reasons
ICH recurrence5 years after ICHPatients had an another ICH after this ictus
3-month outcome3 months after ICH3-month outcome is measured using modified Rankin Scale (mRS) score

Secondary

MeasureTime frameDescription
hematoma volumeup to 5 hours (A few hours after ICH)The volume of hematoma according to CT scan at the baseline when patients arrived at the emergency room
hematoma expansionwithin 48 hours after ICHPatients had another CT scan during 24-48 hours after the first CT, and hematoma volume growth exceeding 33% or absolute hematoma growth exceeding 6ml
cerebral small vessel diseases (CSVDs)within 2 weeks after ICHcerebral small vessel diseases evaluated by MRI, including cortical superficial siderosis (cSS), white matter hyperintensity (WMH), cerebral microbleed (CMB), etc.

Countries

China

Contacts

Primary ContactFeng Gao, Dr
2202012@zju.edu.cn+86-13588451471

Outcome results

None listed

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