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Forced Air Versus Endovascular Warming in Polytrauma Patients (FAEWPP)

This study has suspended participant recruitment.
(Not enough patients)
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00555126
First received: November 6, 2007
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Polytrauma
Hypothermia
 Device: Forced Air Warming
Device: Warming with endovascular catheter + forced air warming
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Combined Perioperative Morbidity [ Time Frame: During LOS (approximately 30 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Loss [ Time Frame: Perioperative Period ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: Perioperative Period, during LOS ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555126

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Lorenz Böhler Unfallkrankenhaus
Vienna, Austria, 1200
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Oliver Kimberger, M.D. Medical University of Vienna
  More Information

Publications:

Responsible Party: Dr. Oliver Kimberger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00555126     History of Changes
Other Study ID Numbers: Polytrauma-007
Study First Received: November 6, 2007
Last Updated: July 27, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
Polytrauma
Hypothermia
Wound Infection
Blood Loss
Combined perioperative morbidity

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013