Forced Air Versus Endovascular Warming in Polytrauma Patients (FAEWPP)
Primary Purpose
Polytrauma, Hypothermia
Status
Suspended
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Forced Air Warming
Warming with endovascular catheter + forced air warming
Sponsored by
About this trial
This is an interventional treatment trial for Polytrauma focused on measuring Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity
Eligibility Criteria
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.
Sites / Locations
- Medical University of Vienna
- Lorenz Böhler Unfallkrankenhaus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Warming with Forced Air
Endovascular Warming
Arm Description
Forced Air Warming
Warming with Endovascular Catheter
Outcomes
Primary Outcome Measures
Combined Perioperative Morbidity
Secondary Outcome Measures
Blood Loss
Infection
Full Information
NCT ID
NCT00555126
First Posted
November 6, 2007
Last Updated
July 27, 2010
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00555126
Brief Title
Forced Air Versus Endovascular Warming in Polytrauma Patients
Acronym
FAEWPP
Official Title
A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Suspended
Why Stopped
Not enough patients
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polytrauma, Hypothermia
Keywords
Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Warming with Forced Air
Arm Type
Active Comparator
Arm Description
Forced Air Warming
Arm Title
Endovascular Warming
Arm Type
Experimental
Arm Description
Warming with Endovascular Catheter
Intervention Type
Device
Intervention Name(s)
Forced Air Warming
Intervention Description
Warming after Randomization
Intervention Type
Device
Intervention Name(s)
Warming with endovascular catheter + forced air warming
Intervention Description
Warming after Randomization
Primary Outcome Measure Information:
Title
Combined Perioperative Morbidity
Time Frame
During LOS (approximately 30 days)
Secondary Outcome Measure Information:
Title
Blood Loss
Time Frame
Perioperative Period
Title
Infection
Time Frame
Perioperative Period, during LOS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Kimberger, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Lorenz Böhler Unfallkrankenhaus
City
Vienna
ZIP/Postal Code
1200
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
10639541
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.
Results Reference
background
PubMed Identifier
11004060
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.
Results Reference
background
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Forced Air Versus Endovascular Warming in Polytrauma Patients
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