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临床试验/NCT00555126
NCT00555126暂停4 期

A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims

Medical University of Vienna4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
4 期
状态
暂停
入组人数
100
试验地点
4
主要终点
Combined Perioperative Morbidity

研究概览

简要总结

Trauma is the leading cause of death in young adults, bleeding and infection are major concomitant problems. We test the hypothesis that fast, perioperative warming with an endovascular catheter versus forced air warming may improve patient outcome (primary outcome: combined perioperative morbidity, secondary outcome: bleeding, infection).

详细描述

Trauma is the leading cause of death in young adults and a major cause of morbidity and mortality at all ages. The acute problem is often uncontrollable bleeding. Subsequently, infection becomes a leading cause of morbidity. Polytrauma patients are at high risk for accidental hypothermia. Mild perioperative hypothermia causes a coagulopathy that significantly augments blood loss and increases allogeneic transfusion requirements. Hypothermia also impairs numerous immune functions - even slight decreases in core temperature triple the risk of surgical wound infection.

Endovascular temperature management system Alsius® (ICY, Alsius Corporation: Irvine,California,USA) has been approved in Europe and United States for the past 10 years and has been used in thousands of patients mainly for the indication of therapeutic cooling and subsequently rewarming of patients. A major potential advantage of this system is that heat is directly added to the thermal core, thus bypassing the heat sink and insulating effects of peripheral tissues. The efficacy of this system is sufficient to allow rapid rewarming in hypothermic trauma victims, even those undergoing major surgery. We therefore propose to test the hypothesis that polytrauma patients rewarmed with the Alsius® system will have better patient outcome (combined perioperative morbidity) than those warmed conventionally with forced-air.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • We will evaluate patients admitted to the Emergency department for polytrauma. Patients will be eligible for the study when they:
  • Are between 18 and 70 years old
  • Have a Glasgow coma score ≥ 9
  • An ISS (Injury Severity Score) ≥16; and
  • Have A Severity Characterisation Of Trauma (ASCOT) score predicting mortality ranging from 2 to 50% (www.sfar.org/scores2/ascot2.html).

排除标准

  • Patients will be excluded if they are:
  • <150cm in height
  • Known to have a vena cava filter
  • Known to have a history of coagulopathy including anti-coagulant medications; or
  • Known to be pregnant.

结局指标

主要结局

Combined Perioperative Morbidity

时间窗: During LOS (approximately 30 days)

次要结局

  • Blood Loss(Perioperative Period)
  • Infection(Perioperative Period, during LOS)

研究者

申办方类型
Other

研究点 (4)

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