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InjuryNCT02165137

Management of Major Trauma Patients at Aarau Trauma Center - Evaluation of Processes and Patient Outcome

An observational study of Injury and Trauma, run by Kantonsspital Aarau at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Quality control and improvement project: Assessment and analysis of processes and outcome in trauma emergency room and major trauma patients at the Aarau trauma center (cantonal hospital) with regard to initial emergency management, hospital processes and short- and long-term (1-and 2-year) outcome of patients… Read more about this study

Who is it for?
Any age
Conditions the study is for
Injury, Trauma, Major Trauma
How many people
3,800 participants
Where
1 siteSwitzerland
Study dates
Jan 2010to Dec 2020
How long will I take part?
2 Years
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All emergency patients treated at Aarau Cantonal Hospital following trauma (<24h postinjury) with suspected major trama

Who may be able to join

  • major trauma: New Injury Severity Score (NISS) >=8
  • for longer-term outcome: only patients firm in German language and able to respond to the postal questionnaire by themselves

Who cannot join

  • no Trauma
  • injury >24h before arrival at Aarau Cantonal Hospital
  • NISS<8
  • for longer-term outcome: patients not firm in German language and not able to respond to the postal questionnaire by themselves (dead, unavailable, refusal to participate, dementia, age<16 years ecc.); a categorising compilation of cases is supposed to exclude any possible study bias

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Aarau Cantonal Hospital

    Aarau, Canton of Aargau, 5001

Other trials in Switzerland

About this study

Official title: Quality Control in the Management of Major Trauma Patients at Aarau Cantonal Hospital - Evaluation of Processes and Patient Outcome

Quality control and improvement project: Assessment and analysis of processes and outcome in trauma emergency room and major trauma patients at the Aarau trauma center (cantonal hospital) with regard to initial emergency management, hospital processes and short- and long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of processes and outcome pre- and post- project initiative. Benchmarking with the literature and by participation in the German and Swiss Trauma registry each.

Read the detailed description

Registry of all emergency patients arriving at Aarau trauma center following trauma with regard to possibly injury related pre- and inhospital demographic factors, process variables and outcome Parameters.

Keywords
trauma, major trauma, multiple trauma, outcome, quality, process Management, emergency room, trauma center
Medical subject headings
Wounds and Injuries, Multiple Trauma, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02165137
Study groupRoleWhat they receive
trauma patientstype and severity of patients, circumstances and trauma pre- and post-injury / -quality initiative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. emergency room process times

    Measured: hours (<6)

Secondary outcomes (6)

  1. hospital mortality

    Measured: 30 days

  2. Euro Quality of Life Group health-related quality of life on five dimensions (EQ-5D)

    score

    Measured: 1 and 2 year follow-up

  3. Trauma Outcome Profile (TOP)

    score

    Measured: 1 and 2 year follow-up

  4. Quality of Life after Brain Injury (QOLIBRI)

    score

    Measured: 1 and 2 year follow-up

  5. medical outcomes study Short Form-36 (SF-36)

    score

    Measured: 1 and 2 year follow-up

  6. reduced capacity to work

    Value (%);e.g. see Gross T, Attenberger C, Huegli RW, Amsler F. Factors associated with reduced longer-term capacity to work in patients after polytrauma: a Swiss trauma center experience. J Am Coll Surg. 2010 Jul;211(1):81-91

    Measured: 1 and 2 year outcome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2019
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,800 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02165137
Sponsor's protocol ID
2012-008
Other IDs
2012-008
Status last verified
Mar 2024
First submitted
11 Jun 2014
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • Gross T, Amsler F. Prevalence and incidence of longer term pain in survivors of polytrauma. Surgery. 2011 Nov;150(5):985-95. doi: 10.1016/j.surg.2011.04.003. Epub 2011 Jun 15.

    PubMed 21676423

  • Attenberger C, Amsler F, Gross T. Clinical evaluation of the Trauma Outcome Profile (TOP) in the longer-term follow-up of polytrauma patients. Injury. 2012 Sep;43(9):1566-74. doi: 10.1016/j.injury.2011.01.002. Epub 2011 Jan 20.

    PubMed 21255778

  • Gross T, Attenberger C, Huegli RW, Amsler F. Factors associated with reduced longer-term capacity to work in patients after polytrauma: a Swiss trauma center experience. J Am Coll Surg. 2010 Jul;211(1):81-91. doi: 10.1016/j.jamcollsurg.2010.02.042. Epub 2010 May 15.

    PubMed 20610253

  • Fueglistaler P, Amsler F, Schuepp M, Fueglistaler-Montali I, Attenberger C, Pargger H, Jacob AL, Gross T. Prognostic value of Sequential Organ Failure Assessment and Simplified Acute Physiology II Score compared with trauma scores in the outcome of multiple-trauma patients. Am J Surg. 2010 Aug;200(2):204-14. doi: 10.1016/j.amjsurg.2009.08.035. Epub 2010 Mar 15.

    PubMed 20227058

  • Fuglistaler-Montali I, Attenberger C, Fuglistaler P, Jacob AL, Amsler F, Gross T. In search of benchmarking for mortality following multiple trauma: a Swiss trauma center experience. World J Surg. 2009 Nov;33(11):2477-89. doi: 10.1007/s00268-009-0193-1.

    PubMed 19693630

  • Gross T, Schuepp M, Attenberger C, Pargger H, Amsler F. Outcome in polytraumatized patients with and without brain injury. Acta Anaesthesiol Scand. 2012 Oct;56(9):1163-74. doi: 10.1111/j.1399-6576.2012.02724.x. Epub 2012 Jun 26.

    PubMed 22735047

  • Gross T, Morell S, Scholz SM, Amsler F. The capacity of baseline patient, injury, treatment and outcome data to predict reduced capacity to work and accident insurer costs - a Swiss prospective 4-year longitudinal trauma centre evaluation. Swiss Med Wkly. 2019 Dec 17;149:w20144. doi: 10.4414/smw.2019.20144. eCollection 2019 Dec 16.

    PubMed 31846504

  • Gross T, Morell S, Amsler F. To What Extent Are Main Accident-Insurer Cases Representative of All Significantly Injured? A Swiss Monocenter Perspective. J Insur Med. 2019;48(1):65-78. doi: 10.17849/insm-48-1-1-14.1. Epub 2019 Apr 24.

    PubMed 31017516

  • Gross T, Morell S, Amsler F. Gender-Specific Improvements in Outcome 1 and 2 Years After Major Trauma. J Surg Res. 2019 Mar;235:459-469. doi: 10.1016/j.jss.2018.10.024. Epub 2018 Nov 21.

    PubMed 30691830

  • Gross T, Braken P, Amsler F. Trauma center need: the American College of Surgeons' definition in contrast to Swiss highly specialized medicine regulations-a Swiss trauma center perspective. Eur J Trauma Emerg Surg. 2020 Apr;46(2):397-406. doi: 10.1007/s00068-018-1027-3. Epub 2018 Oct 13.

    PubMed 30317378

  • Born K, Amsler F, Gross T. Prospective evaluation of the Quality of Life after Brain Injury (QOLIBRI) score: minor differences in patients with major versus no or mild traumatic brain injury at one-year follow up. Health Qual Life Outcomes. 2018 Jul 9;16(1):136. doi: 10.1186/s12955-018-0966-z.

    PubMed 29986710

  • Gross T, Amsler F. One-year outcome following brain injury: a comparison of younger versus elderly major trauma patients. Arch Orthop Trauma Surg. 2018 Oct;138(10):1375-1387. doi: 10.1007/s00402-018-2974-1. Epub 2018 Jun 11.

    PubMed 29948226

  • Gross T, Morell S, Amsler F. Longer-term quality of life following major trauma: age only significantly affects outcome after the age of 80 years. Clin Interv Aging. 2018 Apr 30;13:773-785. doi: 10.2147/CIA.S158344. eCollection 2018.

    PubMed 29750022

  • Braken P, Amsler F, Gross T. Simple modification of trauma mechanism alarm criteria published for the TraumaNetwork DGU(R) may significantly improve overtriage - a cross sectional study. Scand J Trauma Resusc Emerg Med. 2018 Apr 24;26(1):32. doi: 10.1186/s13049-018-0498-x.

    PubMed 29690930

  • Bundi M, Meier L, Amsler F, Gross T. [Impact of weather, time of day and season on the admission and outcome of major trauma patients]. Unfallchirurg. 2018 Jan;121(1):10-19. doi: 10.1007/s00113-016-0267-0. German.

    PubMed 27778061

Questions about this trial

What is this clinical trial studying?

An observational study of Injury and Trauma, run by Kantonsspital Aarau at 1 site in Switzerland.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

emergency room process times (time frame: hours (<6)). 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 NCT02165137, which also lists 23 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 15 Mar 2024.

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