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临床试验/NCT06548737
NCT06548737招募中不适用

Clinical Outcomes Following Primary Intracerebral Hemorrhage:A Multicenter Cohort Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 25,000 人开始时间: 2016年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25,000
试验地点
1
主要终点
ICH recurrence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

ICH recurrence

时间窗: 5 years after ICH

Patients had an another ICH after this ictus

All-cause death

时间窗: 5 years after ICH

Patients die of any reasons

3-month outcome

时间窗: 3 months after ICH

3-month outcome is measured using modified Rankin Scale (mRS) score

次要结局

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

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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