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临床试验/NCT02575989
NCT02575989已完成不适用

Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 1,086 人开始时间: 2016年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,086
试验地点
2
主要终点
Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)

研究概览

简要总结

The purpose of this study is to demonstrate that the specific management will increase the number of alive trauma patient arriving with a temperature > 35°C.

详细描述

Trauma patients are often hypothermic (temperature < 35 °C) upon arrival at the hospital. Hypothermia is with hypotension and hypoxia, perfectly known to be directly responsible for complications.

Hypothermia is responsible, with acidosis and coagulopathy, of the " lethal triad" of trauma.

Thus, it is clearly established that hypothermia is directly associated with poor prognostic in trauma patients. In a recent study, mortality rate reached 100% for trauma patients arriving at the hospital with a body temperature below 32°C.

The weather, the severity of the trauma and medical (or paramedical) interventions are responsible for the onset of this hypothermia.

Then, continuous monitoring of the patient's temperature, active protection against hypothermia with a metal blanket, the warming (and measure the temperature of) infusion fluids, the warming (and measure the temperature of) the ambulance should improve patient's outcome. As hypothermia is associated with mortality of trauma patients, the control must lead to reduce mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)

时间窗: Day0

次要结局

  • Survival at hospital discharge(up to 3 months)
  • Length of stay at hospital (days)(up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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