- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555126
Forced Air Versus Endovascular Warming in Polytrauma Patients (FAEWPP)
A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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Vienna, Austria, 1200
- Lorenz Böhler Unfallkrankenhaus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
We will evaluate patients admitted to the Emergency department for polytrauma. Patients will be eligible for the study when they:
- Are between 18 and 70 years old
- Have a Glasgow coma score ≥ 9
- An ISS (Injury Severity Score) ≥16; and
- 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:
- <150cm in height
- Known to have a vena cava filter
- Known to have a history of coagulopathy including anti-coagulant medications; or
- Known to be pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Warming with Forced Air
Forced Air Warming
|
Warming after Randomization
|
Experimental: Endovascular Warming
Warming with Endovascular Catheter
|
Warming after Randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Combined Perioperative Morbidity
Time Frame: During LOS (approximately 30 days)
|
During LOS (approximately 30 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Loss
Time Frame: Perioperative Period
|
Perioperative Period
|
Infection
Time Frame: Perioperative Period, during LOS
|
Perioperative Period, during LOS
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oliver Kimberger, M.D., Medical University of Vienna
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Polytrauma-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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