Forced Air Versus Endovascular Warming in Polytrauma Patients

NCT ID: NCT00555126

Last Updated: 2010-07-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-01-31

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.

Conditions

Polytrauma; Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Warming with Forced Air

Forced Air Warming

Group Type: ACTIVE_COMPARATOR

Forced Air Warming

Intervention Type: DEVICE

Warming after Randomization

Endovascular Warming

Warming with Endovascular Catheter

Group Type: EXPERIMENTAL

Warming with endovascular catheter + forced air warming

Intervention Type: DEVICE

Warming after Randomization

Interventions

Forced Air Warming

Warming after Randomization

Intervention Type: DEVICE

Warming with endovascular catheter + forced air warming

Warming after Randomization

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Principal Investigators

Oliver Kimberger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Lorenz Böhler Unfallkrankenhaus

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 10639541 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11004060 (View on PubMed)

Other Identifiers

Polytrauma-007

Identifier Type: -

Identifier Source: org_study_id