Forced Air Versus Endovascular Warming in Polytrauma Patients

NCT00555126 | Suspended Phase 4 DMC

• 1 other identifier: Polytrauma-007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Polytrauma; Hypothermia

Keywords

Polytrauma; Hypothermia; Wound Infection; Blood Loss; Combined perioperative morbidity

Outcome Measures

Primary Outcomes (1)

• Combined Perioperative Morbidity

  During LOS (approximately 30 days)

Secondary Outcomes (2)

• Blood Loss

  Perioperative Period

• Infection

  Perioperative Period, during LOS

Study Arms (2)

Warming with Forced Air

ACTIVE COMPARATOR

Forced Air Warming

Device: Forced Air Warming

Endovascular Warming

EXPERIMENTAL

Warming with Endovascular Catheter

Device: Warming with endovascular catheter + forced air warming

Interventions

Forced Air Warming DEVICE

Warming after Randomization

Warming with Forced Air

Warming with endovascular catheter + forced air warming DEVICE

Warming after Randomization

Endovascular Warming

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Lorenz Böhler Unfallkrankenhaus

Vienna, Vienna, 1200, Austria

Location

Related Publications (2)

• 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.

  PMID: 10639541 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.

  PMID: 11004060 BACKGROUND

MeSH Terms

Conditions

Multiple Trauma; Hypothermia; Wound Infection; Hemorrhage

Condition Hierarchy (Ancestors)

Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Pathologic Processes

Study Officials

• Oliver Kimberger, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: May 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 28, 2010

Record last verified: 2010-07

Locations

AU (2)