deltatrials
Suspended PHASE4 INTERVENTIONAL 2-arm 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

Sponsor: Medical University of Vienna

Updated 6 times since 2017 Last updated: Jul 27, 2010 Started: May 31, 2008 Primary completion: Jan 31, 2011 Completion: Jan 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Suspended

Not enough patients

This PHASE4 trial investigates Hypothermia and Polytrauma and is currently suspended. Medical University of Vienna leads this study, which shows 6 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotSuspended~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotSuspended~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotSuspended~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotSuspended~Sep 2024 – present · 19 months · monthly snapshotSuspended~Jan 2026 – present · 3 months · monthly snapshotSuspended

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Suspended PHASE4

  2. Sep 2024 — Present [monthly]

    Suspended PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Suspended PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Suspended PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Suspended PHASE4

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Suspended PHASE4

    First recorded

May 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medical University of Vienna
Data source: Medical University of Vienna

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations