Clinical trial NCT06548737: Clinical Outcomes Following Primary Intracerebral Hemorrhage
Official title: Clinical Outcomes Following Primary Intracerebral Hemorrhage：A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Intracerebral Hemorrhage
Keywords: Primary intracerebral hemorrhage
Stroke
Outcomes
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The People's Hospital of Haiyan
name: Taizhou First People's Hospital
name: The First People's Hospital of Pinghu
name: The 2nd People's Hospital of Quzhou
First posted: 2024-08-12
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute primary intracerebral hemorrhage

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause death
timeFrame: 5 years after ICH
measure: ICH recurrence
timeFrame: 5 years after ICH
measure: 3-month outcome
timeFrame: 3 months after ICH
Secondary outcomes:
measure: hematoma volume
timeFrame: up to 5 hours (A few hours after ICH)
measure: hematoma expansion
timeFrame: within 48 hours after ICH
measure: cerebral small vessel diseases (CSVDs)
timeFrame: within 2 weeks after ICH
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Feng Gao, Dr
role: STUDY_CHAIR
References: