Forced Air Versus Endovascular Warming in Polytrauma Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Polytrauma, Hypothermia

Intervention / Treatment
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* Device: Forced Air Warming
* Device: Warming with endovascular catheter + forced air warming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warming with Forced Air<br>Forced Air Warming | Device: Forced Air Warming<br>* Warming after Randomization<br>|
| Experimental: Endovascular Warming<br>Warming with Endovascular Catheter | Device: Warming with endovascular catheter + forced air warming<br>* Warming after Randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Perioperative Morbidity |  | During LOS (approximately 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss |  | Perioperative Period | 
| Infection |  | Perioperative Period, during LOS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity