- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165137
Management of Major Trauma Patients at Aarau Trauma Center - Evaluation of Processes and Patient Outcome
March 12, 2024 updated by: Thomas Gross, MD, Kantonsspital Aarau
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
3800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aargau
-
Aarau, Aargau, Switzerland, 5001
- Aarau Cantonal Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All emergency patients treated at Aarau Cantonal Hospital following trauma (<24h postinjury) with suspected major trama
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
trauma patients
type and severity of patients, circumstances and trauma pre- and post-injury / -quality initiative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
emergency room process times
Time Frame: hours (<6)
|
hours (<6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospital mortality
Time Frame: 30 days
|
30 days
|
|
Euro Quality of Life Group health-related quality of life on five dimensions (EQ-5D)
Time Frame: 1 and 2 year follow-up
|
score
|
1 and 2 year follow-up
|
Trauma Outcome Profile (TOP)
Time Frame: 1 and 2 year follow-up
|
score
|
1 and 2 year follow-up
|
Quality of Life after Brain Injury (QOLIBRI)
Time Frame: 1 and 2 year follow-up
|
score
|
1 and 2 year follow-up
|
medical outcomes study Short Form-36 (SF-36)
Time Frame: 1 and 2 year follow-up
|
score
|
1 and 2 year follow-up
|
reduced capacity to work
Time Frame: 1 and 2 year outcome
|
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
|
1 and 2 year outcome
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
invalidity
Time Frame: at least 4 year post-injury
|
% of disability to work (i.e., basis for resulting amount of insurance pension)
|
at least 4 year post-injury
|
insurance payments
Time Frame: at least 4 years post-injury
|
Swiss Francs
|
at least 4 years post-injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Gross, MD, Prof., Aarau Cantonal Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gross T, Amsler F. [Long-term outcome following multiple trauma in working age : A prospective study in a Swiss trauma center]. Unfallchirurg. 2016 Nov;119(11):921-928. doi: 10.1007/s00113-014-2720-2. German.
- Gross T, Amsler F. [Emergency room and major trauma treatment is a "loss-making business" : A Swiss trauma center experience with current DRG reimbursement]. Unfallchirurg. 2021 Sep;124(9):747-754. doi: 10.1007/s00113-020-00937-w. Epub 2020 Dec 18. German.
- Walkner S, Amsler F, Gross T. [How often is a chest tube needed following thoracic trauma in the severely injured-and when is more needed? : Data from a Swiss trauma center for planning of resources and surgical training]. Chirurg. 2021 Aug;92(8):721-728. doi: 10.1007/s00104-020-01292-7. German.
- Gross T, Morell S, Amsler F. Medically graded reduced capacity to work (RCW) following significant injury as explained by patient related outcome measures (PROMs): A prospective trauma center evaluation. Disabil Health J. 2021 Oct;14(4):101114. doi: 10.1016/j.dhjo.2021.101114. Epub 2021 May 10.
- Gross T, Amsler F. Main factors predicting somatic, psychological, and cognitive patient outcomes after significant injury: a pilot study of a simple prognostic tool. BJS Open. 2021 Nov 9;5(6):zrab109. doi: 10.1093/bjsopen/zrab109.
- Zeindler M, Amsler F, Gross T. Comparative analysis of MGAP, GAP, and RISC2 as predictors of patient outcome and emergency interventional need in emergency room treatment of the injured. Eur J Trauma Emerg Surg. 2021 Dec;47(6):2017-2027. doi: 10.1007/s00068-020-01361-w. Epub 2020 Apr 13.
- Fiumedinisi FA, Amsler F, Gross T. Short-term outcome following significant trauma: increasing age per se has only a relatively low impact. Eur J Trauma Emerg Surg. 2021 Dec;47(6):1979-1992. doi: 10.1007/s00068-020-01357-6. Epub 2020 Apr 16.
- Magyar CTJ, Maeder F, Diepers M, Amsler F, Gross T. Detailed information gain and therapeutic impact of whole body computed tomography supplementary to conventional radiological diagnostics in blunt trauma emergency treatment: a consecutive trauma centre evaluation. Eur J Trauma Emerg Surg. 2022 Apr;48(2):921-931. doi: 10.1007/s00068-020-01502-1. Epub 2020 Sep 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
June 11, 2014
First Submitted That Met QC Criteria
June 13, 2014
First Posted (Estimated)
June 17, 2014
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-008 (Other Identifier: Kantonale Ethikkommission AG/ SO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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