Clinical Outcomes Following Primary Intracerebral Hemorrhage

Официальное название

Clinical Outcomes Following Primary Intracerebral Hemorrhage：A Multicenter Cohort Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• All-cause death [Срок оценки: 5 years after ICH]
• ICH recurrence [Срок оценки: 5 years after ICH]
• 3-month outcome [Срок оценки: 3 months after ICH]

Вторичные конечные точки (3)

• hematoma volume [Срок оценки: up to 5 hours (A few hours after ICH)]
• hematoma expansion [Срок оценки: within 48 hours after ICH]
• cerebral small vessel diseases (CSVDs) [Срок оценки: within 2 weeks after ICH]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University — Ханчжоу

Публикации

• 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

Идентификаторы

NCT: NCT06548737 · ZJU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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