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Forced Air Versus Endovascular Warming in Polytrauma Patients

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

Status
Suspended
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00555126
Acronym
FAEWPP
Enrollment
100
Registered
2007-11-07
Start date
2008-05-31
Completion date
2011-01-31
Last updated
2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Polytrauma

Keywords

Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity

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.

Interventions

Warming after Randomization

DEVICEWarming with endovascular catheter + forced air warming

Warming after Randomization

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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% (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.

Design outcomes

Primary

MeasureTime frame
Combined Perioperative MorbidityDuring LOS (approximately 30 days)

Secondary

MeasureTime frame
Blood LossPerioperative Period
InfectionPerioperative Period, during LOS

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026