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临床试验/NCT03157453
NCT03157453终止不适用

Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2017年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
367
试验地点
1
主要终点
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)

研究概览

简要总结

Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.

The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.

The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).

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

入选标准

  • All patients aged 18 years or more
  • Potentially Victim of a cerebral injury whatever the level of severity
  • Having a calculation of GCS and KBS on arrival at the hospital (emergency room)
  • Affiliated to a social security scheme or benefiting through a third person.

排除标准

  • Pregnant women
  • Patients who refusing to participate in research
  • Patients undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).

结局指标

主要结局

Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)

时间窗: 6 months

次要结局

  • Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for medical injury(6 months)
  • Mortality in intensive care unit(6 months)
  • Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for traumatized cranial(6 months)
  • Duration of stay at hospital(6 months)
  • Mortality at hospital(6 months)
  • Mortalit at 6 months(6 months)
  • Duration of stay in intensive care unit(6 months)
  • Duration of mechanical ventilation(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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