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临床试验/NCT07739030
NCT07739030已完成不适用

Associations Between Prehospital Physiological Parameters and Functional Outcome in Severe Spontaneous Intracerebral Hemorrhage: a Retrospective Cohort Study

Kirsten Moller1 个研究点 分布在 1 个国家目标入组 678 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
678
试验地点
1
主要终点
Functional status at 6 months

研究概览

简要总结

Spontaneous intracerebral hemorrhage (ICH) represents 10-15% of all strokes and is associated with high mortality and morbidity. Rapid identification and interventions, e.g. early implementation of care bundles, seem to be critical for improving outcome. Nonetheless, relatively little is known about the influence of acute physiological risk factors in the prehospital phase, although high prehospital blood pressure has been associated with worse outcome in mild to moderate ICH. Whether the same applies to severe ICH requiring neurointensive care is unclear and furthermore the prognostic impact of other physiological variables has received little attention. The aim of this study is to retrospectively investigate prehospital characteristics of severe ICH and whether physiological abnormalities are associated with functional outcome, mortality after six months, and early withdrawal of life sustaining treatment.

详细描述

This study investigates the association between prehospital blood pressure, neurological deficits, glucose, hypoxia and outcome in patients admitted to the neurointensive care unit at Copenhagen University Hospital, Rigshospitalet, between 11-01-2016 and 10-01-2025. All data pertaining to the first 24 hours from admission to first hospital, baseline characteristics, comorbidities, decisions to withdraw care within 24 hours and functional outcome and mortality at six months were extracted from electronic medical journals, while prehospital data was extracted from the Danish National Prehospital Database and supplemented with scanned EMS records when available.

研究设计

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

入排标准

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

入选标准

  • Primary spontaneous ICH confirmed by CT imaging.
  • Admission to the neurointensive care unit at Rigshospitalet within the study period.
  • Available prehospital journal linked to the initial hospital admission.

排除标准

  • Age below 18
  • ICH secondary to trauma, vascular malformation, tumour, haemorrhagic transformation of ischaemic stroke, aneurysms, or central venous sinus thrombosis.
  • Initial admission without confirmed ICH.
  • Admissions from hospitals outside the Capital Region of Denmark or Region Zealand.
  • Pure intraventricular hemorrhage without parenchymal involvement as determined by a radiologist.
  • Intrahospital ICH.
  • Iatrogenic ICH

结局指标

主要结局

Functional status at 6 months

时间窗: Time Frame: From ictus onset of symptoms or last seen well to six months

Modified Rankin Scale, mRS, (0-6 where lower scores mean a better outcome), with favourable outcomes defined as mRS of 0-3 and unfavourable 4-6

Mortality at 6 months

时间窗: From ictus to six months

Percent

Early withdrawal of life sustaining treatment

时间窗: First 24 hours from admission to primary hospital

Percent

次要结局

  • In hospital death(From hospital admission at day 1 until any death date coinciding with hospital discharge, assessed up to 36 months)
  • Length of stay(From hospital admission at day 1 to hospital discharge or in-hospital death, assessed up to 36 months)

研究者

发起方
Kirsten Moller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kirsten Moller

Clinical Professor

Rigshospitalet, Denmark

研究点 (1)

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