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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Switzerland
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
trauma patients
type and severity of patients, circumstances and trauma pre- and post-injury / -quality initiative

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
emergency room process times
Time Frame: hours (<6)
hours (<6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kantonsspital Aarau

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kantonsspital Aarau, Wissenschaftlicher Fond
Suva

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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