Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes

December 17, 2019 updated by: University Hospital, Basel, Switzerland
The aim of the analysis is an evaluation of the current performance of the Swiss Trauma Registry (STR) with respect to providing a reliable basis for (scientific) investigations on the management of trauma patients in Switzerland. The current project tries to address this question by considering central aspects of completeness and by exemplifying the use of the registry for research questions. The aim is to identify potential shortcomings of the registry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

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
      • Basel, Switzerland, 4031
        • Department of Orthopaedics and Trauma Surgery (DOTS).

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The data source for this project is the Swiss Trauma Registry with approx. 65 patients per year. Data will be extracted from the databank and transferred for analysis in anonymized form.

Description

Inclusion Criteria:

  • documentation in the STR
  • Injury Severity Score (ISS) ≥ 16

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analysis of data completeness
Time Frame: single time point assessment at baseline
The STR comprises patient data starting from preclinical management, resuscitation, hospitalization and discharge data as well as data considering 28-day mortality, long-term outcome and cost. The founders agreed on a total of 98 items for analyses. All data sets will be evaluated for completeness of the 98 data points (items).
single time point assessment at baseline
rate of 28 day survival
Time Frame: single time point assessment at baseline
analysis of patient outcome: rate of patients' 28 day survival
single time point assessment at baseline
length of hospital stay
Time Frame: single time point assessment at baseline
analysis of patient outcome: length of hospital stay (days)
single time point assessment at baseline
rate of patients receiving intensive care treatment
Time Frame: single time point assessment at baseline
analysis of patient outcome: rate of patients receiving intensive care treatment
single time point assessment at baseline
rate of patients returning to the previous living situation
Time Frame: single time point assessment at baseline
analysis of patient outcome: rate of patients returning to the previous living situation
single time point assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost of maintenance of the register
Time Frame: single time point assessment at baseline
analysis of how many pro-rata salary per cent annually are specifically invested in the maintenance of the register
single time point assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Nicolas Bless, Dr. med, Department Orthopedic and Trauma Surgery, University Hospital Basel

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 (Actual)

November 1, 2018

Primary Completion (Actual)

December 12, 2019

Study Completion (Actual)

December 12, 2019

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01907; ch19Bless

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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