Clinical trial NCT00555126: Forced Air Versus Endovascular Warming in Polytrauma Patients
Official title: A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Polytrauma
Hypothermia
Keywords: Polytrauma
Hypothermia
Wound Infection
Blood Loss
Combined perioperative morbidity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Combined Perioperative Morbidity
timeFrame: During LOS (approximately 30 days)
Secondary outcomes:
measure: Blood Loss
timeFrame: Perioperative Period
measure: Infection
timeFrame: Perioperative Period, during LOS
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Lorenz Böhler Unfallkrankenhaus
Study officials:
affiliation: Medical University of Vienna
name: Oliver Kimberger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.