Forced Air Versus Endovascular Warming in Polytrauma Patients

Phase 4

Suspended

• Conditions: Polytrauma; Hypothermia
• Interventions: Device: Forced Air Warming; Device: Warming with endovascular catheter + forced air warming

• Registration Number: NCT00555126
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Study Start: 2008-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-27
• Last Update Posted: 2010-07-28
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

We will evaluate patients admitted to the Emergency department for polytrauma. Patients will be eligible for the study when they:

1. Are between 18 and 70 years old
2. Have a Glasgow coma score ≥ 9
3. An ISS (Injury Severity Score) ≥16; and
4. 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:

1. <150cm in height
2. Known to have a vena cava filter
3. Known to have a history of coagulopathy including anti-coagulant medications; or
4. Known to be pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Warming with Forced Air	Forced Air Warming	Forced Air Warming
Endovascular Warming	Warming with endovascular catheter + forced air warming	Warming with Endovascular Catheter

Primary Outcome Measures

Name	Time	Method
Combined Perioperative Morbidity	During LOS (approximately 30 days)

Secondary Outcome Measures

Name	Time	Method
Blood Loss	Perioperative Period
Infection	Perioperative Period, during LOS

Trial Locations

Locations (2)

Lorenz Böhler Unfallkrankenhaus; 🇦🇹 Vienna, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria