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临床试验/NCT03956485
NCT03956485Unknown不适用

Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau26 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,500
试验地点
26
主要终点
Functional outcome

研究概览

简要总结

A population-based registry in Catalonia of patients with acute spontaneous Intracerebral Hemorrhage, to investigate whether type of center and time from onset to admission is associated with functional outcome and mortality.

详细描述

Introduction. Recent studies show that there are potentially beneficial therapeutic measures for the patient with acute intracerebral hemorrhage (ICH), which should be applied urgently and that some would only be available in tertiary stroke centers (TSC). However, the transportation criteria for ICH patients are not well defined.

Objectives: Design and implementation of a registry (HIC-CAT) of patients with HIC in the healthcare network of public hospitals in Catalonia, which does not modify the current logistics but collects data related to patients and TSC, interhospital transfers and non-TSC centers. The registry will allow us to evaluate the hypothesis that: 1) Patient care in TSC decreases the probability of death or dependence in patients with spontaneous ICH compared to non-TSC; and 2) The shorter the time until admission to a TSC, the better the survival and functional outcome. This will be due to the application of diagnostic, therapeutic and structural measures at the TSC. In addition, organ donation will be more frequent in a TSC.

Methods: Observational, prospective, multicentre, population study of 2500 consecutive patients with spontaneous ICH of less than 24 hours from the onset of symptoms and Rankin scale score 0-3. We will collect times, clinical and radiological variables, vital and functional outcome at 3 months follow-up. Number of organ donations. Primary variable: Functional outcome at 3 months (Rankin 0-3). Statistics: Multivariate analysis with logistic regression, propensity matching scores.

研究设计

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

入排标准

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

入选标准

  • •Patient with a diagnosis of spontaneous intracerebral hemorrhage who is diagnosed in any of the participant hospitals

排除标准

  • •Traumatic intracerebral hemorrhage
  • •>24 hours from onset to admission
  • •Prior Rankin scale score >3

结局指标

主要结局

Functional outcome

时间窗: 3 months after onset

Rankin scale score, favourable if 0,1, 2 or 3

次要结局

  • Hematoma expansion(72 hours)
  • Neurological worsening(During admission)
  • Mortality(3 months)
  • Stroke Unit admission(3 months)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (26)

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