PolytraumaPhase 4FAEWPPNCT00555126
Forced Air Versus Endovascular Warming in Polytrauma Patients
A Phase 4 study testing Forced Air Warming and Warming with endovascular catheter + forced air warming in people with Polytrauma and Hypothermia, run by Medical University of Vienna at 2 sites in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polytrauma, Hypothermia
- What is being tested?
- Forced Air Warming and Warming with endovascular catheter + forced air warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesAustria
- Study dates
- May 2008to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna
Vienna, State of Vienna, 1090
Lorenz Böhler Unfallkrankenhaus
Vienna, State of Vienna, 1200
About this study
Official title: A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
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).
Read the 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.
- Conditions
- Polytrauma, Hypothermia
- Being tested
- Forced Air Warming, Warming with endovascular catheter + forced air warming
- Keywords
- Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity
- Medical subject headings
- Multiple Trauma, Hypothermia, Wound Infection, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Air WarmingDevice
Warming after Randomization
Warming with endovascular catheter + forced air warmingDevice
Warming after Randomization
| Study group | Role | What they receive |
|---|---|---|
| Warming with Forced Air | Active comparator | Forced Air Warming Receives: Device: Forced Air Warming |
| Endovascular Warming | Experimental | Warming with Endovascular Catheter Receives: Device: Warming with endovascular catheter + forced air warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Perioperative Morbidity
Measured: During LOS (approximately 30 days)
Secondary outcomes (2)
Blood Loss
Measured: Perioperative Period
Infection
Measured: Perioperative Period, during LOS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startMay 2008
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Kimberger, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555126
- Sponsor's protocol ID
- Polytrauma-007
- Acronym
- FAEWPP
- Status last verified
- Jul 2010
- First submitted
- 6 Nov 2007
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10639541Winkler 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.
PubMed 11004060
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Forced-air With Endovascular Warming for Treatment of Accidental Hypothermia in Polytrauma Victims
- ClinicalTrials.gov ID
- NCT00555126
- Acronym / sponsor ID
- FAEWPP / Polytrauma-007
- Conditions
- Polytrauma, Hypothermia
- Keywords
- Polytrauma, Hypothermia, Wound Infection, Blood Loss, Combined perioperative morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not enough patients
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warming with Forced Air | Active comparator | Device: Forced Air WarmingForced Air Warming |
| Endovascular Warming | Experimental | Device: Warming with endovascular catheter + forced air warmingWarming with Endovascular Catheter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced Air WarmingWarming after Randomization | Device | Warming with Forced Air |
| Warming with endovascular catheter + forced air warmingWarming after Randomization | Device | Endovascular Warming |
Primary outcome
Combined Perioperative Morbidity
Time frame: During LOS (approximately 30 days)
2 secondary outcomes
Blood Loss
Time frame: Perioperative Period
Infection
Time frame: Perioperative Period, during LOS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Background: PubMed 10639541Greif 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.
- Background: PubMed 11004060Winkler 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Kimberger, M.D. principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forced Air Warming and Warming with endovascular catheter + forced air warming in people with Polytrauma and Hypothermia, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Perioperative Morbidity (time frame: During LOS (approximately 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2010.