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Trial record 1 of 1 for:    NCT00555126
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Forced Air Versus Endovascular Warming in Polytrauma Patients (FAEWPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555126
Recruitment Status : Suspended (Not enough patients)
First Posted : November 7, 2007
Last Update Posted : July 28, 2010
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Polytrauma Hypothermia Device: Forced Air Warming Device: Warming with endovascular catheter + forced air warming Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
Study Start Date : May 2008
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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

Primary Outcome Measures :
  1. Combined Perioperative Morbidity [ Time Frame: During LOS (approximately 30 days) ]

Secondary Outcome Measures :
  1. Blood Loss [ Time Frame: Perioperative Period ]
  2. Infection [ Time Frame: Perioperative Period, during LOS ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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% (

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00555126

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Medical University of Vienna
Vienna, Austria, 1090
Lorenz Böhler Unfallkrankenhaus
Vienna, Austria, 1200
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Oliver Kimberger, M.D. Medical University of Vienna
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Responsible Party: Dr. Oliver Kimberger, Medical University of Vienna Identifier: NCT00555126    
Other Study ID Numbers: Polytrauma-007
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010
Keywords provided by Medical University of Vienna:
Wound Infection
Blood Loss
Combined perioperative morbidity
Additional relevant MeSH terms:
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Multiple Trauma
Body Temperature Changes
Wounds and Injuries