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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warming with Forced Air | Active Comparator | Forced Air Warming |
|
| Endovascular Warming | Experimental | Warming with Endovascular Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forced Air Warming | Device | Warming after Randomization |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Perioperative Morbidity | During LOS (approximately 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Perioperative Period | |
| Infection | Perioperative Period, during LOS |
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Inclusion Criteria:
We will evaluate patients admitted to the Emergency department for polytrauma. Patients will be eligible for the study when they:
Exclusion Criteria:
Patients will be excluded if they are:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Kimberger, M.D. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria | ||
| Lorenz Böhler Unfallkrankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10639541 | Background | 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. | |
| 11004060 | Background | 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. |
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| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D007035 | Hypothermia |
| D014946 | Wound Infection |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Warming with endovascular catheter + forced air warming |
| Device |
Warming after Randomization |
|
| Vienna |
| State of Vienna |
| 1200 |
| Austria |
| D007239 | Infections |
| D010335 | Pathologic Processes |