Clinical Outcomes Following Primary Intracerebral Hemorrhage

Recruiting

• Conditions: Stroke; Intracerebral Hemorrhage

• Registration Number: NCT06548737
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2016-10-27
• Status Verified: 2024-06
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2030-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICH recurrence	5 years after ICH	Patients had an another ICH after this ictus
All-cause death	5 years after ICH	Patients die of any reasons
3-month outcome	3 months after ICH	3-month outcome is measured using modified Rankin Scale (mRS) score

Secondary Outcome Measures

Name	Time	Method
hematoma volume	up 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 expansion	within 48 hours after ICH	Patients 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 ICH	cerebral small vessel diseases evaluated by MRI, including cortical superficial siderosis (cSS), white matter hyperintensity (WMH), cerebral microbleed (CMB), etc.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China