Forced Air Versus Endovascular Warming in Polytrauma Patients (FAEWPP)

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

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).

Study Overview

• Status: Suspended
• Conditions: Hypothermia; Polytrauma
• Intervention / Treatment: Device: Forced Air Warming; Device: Warming with endovascular catheter + forced air warming

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, 1200
    • Lorenz Böhler Unfallkrankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Warming with Forced Air; Forced Air Warming	Device: Forced Air Warming; Warming after Randomization
Experimental: Endovascular Warming; Warming with Endovascular Catheter	Device: Warming with endovascular catheter + forced air warming; Warming after Randomization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Oliver Kimberger, M.D., Medical University of Vienna

Publications and helpful links

General Publications

• Winkler M, Akca O, Birkenberg B, Hetz H, Scheck T, Arkilic CF, Kabon B, Marker E, Grubl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84. doi: 10.1097/00000539-200010000-00039.
• Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: November 6, 2007
• First Submitted That Met QC Criteria: November 6, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Estimate): July 28, 2010
• Last Update Submitted That Met QC Criteria: July 27, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Hypothermia; Blood Loss; Polytrauma; Wound Infection; Combined perioperative morbidity
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Multiple Trauma; Hypothermia
• Other Study ID Numbers: Polytrauma-007