Clinical Outcomes Following Primary Intracerebral Hemorrhage

NCT ID: NCT06548737

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-27

Study Completion Date

2033-12-31

Brief Summary

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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

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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.

Conditions

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Stroke Intracerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with primary intracerebral hemorrhage

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 diseases, 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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The People's Hospital of Haiyan

UNKNOWN

Sponsor Role collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Pinghu

UNKNOWN

Sponsor Role collaborator

The 2nd People's Hospital of Quzhou

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng Gao, Dr

Role: STUDY_CHAIR

Zhejiang University

Locations

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The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Gao, Dr

Role: CONTACT

+86-13588451471

Facility Contacts

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Feng Gao, Dr

Role: primary

+86-13588451471

References

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Jin YJ, Yu GS, Tang LL, Li JW, Lin Q, Wu J, Song ZJ, An HN, Ye XH, Liu CJ, Gao F, Tong LS. Sex-specific hemoglobin thresholds and longitudinal trajectories in intracerebral hemorrhage outcomes: a multicenter cohort study. BMC Neurol. 2025 Jul 10;25(1):287. doi: 10.1186/s12883-025-04254-w.

Reference Type DERIVED
PMID: 40640707 (View on PubMed)

Other Identifiers

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ZJU

Identifier Type: -

Identifier Source: org_study_id

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