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Recruiting NCT06548737

Clinical Outcomes Following Primary Intracerebral Hemorrhage

Observational Stroke Intracerebral Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Intracerebral Hemorrhage. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Outcomes Following Primary Intracerebral Hemorrhage:A Multicenter Cohort Study

Overview

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.

Primary outcome measures

  • All-cause death [Time frame: 5 years after ICH]
  • ICH recurrence [Time frame: 5 years after ICH]
  • 3-month outcome [Time frame: 3 months after ICH]
Secondary outcome measures (3)
  • hematoma volume [Time frame: up to 5 hours (A few hours after ICH)]
  • hematoma expansion [Time frame: within 48 hours after ICH]
  • cerebral small vessel diseases (CSVDs) [Time frame: within 2 weeks after ICH]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University — Hangzhou

Publications

  • 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. PMID 40640707

Identifiers

NCT: NCT06548737 · ZJU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗