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

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ClinicalTrials.gov Identifier: NCT02165137
Recruitment Status : Recruiting
First Posted : June 17, 2014
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
Kantonsspital Aarau, Wissenschaftlicher Fond
Suva
Information provided by (Responsible Party):
Thomas Gross, MD, Kantonsspital Aarau

Brief 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 (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.

Condition or disease
Injury Trauma Major Trauma Multiple Trauma

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Quality Control in the Management of Major Trauma Patients at Aarau Cantonal Hospital - Evaluation of Processes and Patient Outcome
Study Start Date : January 2010
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
trauma patients
type and severity of patients, circumstances and trauma pre- and post-injury / -quality initiative



Primary Outcome Measures :
  1. emergency room process times [ Time Frame: hours (<6) ]

Secondary Outcome Measures :
  1. hospital mortality [ Time Frame: 30 days ]
  2. Euro Quality of Life Group health-related quality of life on five dimensions (EQ-5D) [ Time Frame: 1 and 2 year follow-up ]
    score

  3. Trauma Outcome Profile (TOP) [ Time Frame: 1 and 2 year follow-up ]
    score

  4. Quality of Life after Brain Injury (QOLIBRI) [ Time Frame: 1 and 2 year follow-up ]
    score

  5. medical outcomes study Short Form-36 (SF-36) [ Time Frame: 1 and 2 year follow-up ]
    score

  6. 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


Other Outcome Measures:
  1. invalidity [ Time Frame: at least 4 year post-injury ]
    % of disability to work (i.e., basis for resulting amount of insurance pension)

  2. insurance payments [ Time Frame: at least 4 years post-injury ]
    Swiss Francs



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165137


Contacts
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Contact: Thomas Gross, Prof. Dr. thomas.gross@ksa.ch

Locations
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Switzerland
Aarau Cantonal Hospital Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Thomas Gross, Prof. Dr.    +41 62 838 6601    thomas.gross@ksa.ch   
Principal Investigator: Thomas Gross, Prof. Dr.         
Sponsors and Collaborators
Kantonsspital Aarau
Kantonsspital Aarau, Wissenschaftlicher Fond
Suva
Investigators
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Principal Investigator: Thomas Gross, MD, Prof. Aarau Cantonal Hospital

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Gross, MD, Prof. Dr. med., Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT02165137     History of Changes
Other Study ID Numbers: 2012-008
2012-008 ( Other Identifier: Kantonale Ethikkommission AG/ SO )
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Keywords provided by Thomas Gross, MD, Kantonsspital Aarau:
trauma
major trauma
multiple trauma
outcome
quality
process Management
emergency room
trauma center
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries