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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999346
• Other study ID #: 2018-01907; ch19Bless
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 12, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• documentation in the STR

• Injury Severity Score (ISS) = 16

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Multiple Trauma
• Trauma

Intervention

Other:
• retrospective analysis of the Swiss Trauma Registry data
retrospective analysis of protectively documented registry data based on data completeness, patient outcomes, patient characteristics

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Trauma Surgery (DOTS).	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysis of data completeness	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
Primary	rate of 28 day survival	analysis of patient outcome: rate of patients' 28 day survival	single time point assessment at baseline
Primary	length of hospital stay	analysis of patient outcome: length of hospital stay (days)	single time point assessment at baseline
Primary	rate of patients receiving intensive care treatment	analysis of patient outcome: rate of patients receiving intensive care treatment	single time point assessment at baseline
Primary	rate of patients returning to the previous living situation	analysis of patient outcome: rate of patients returning to the previous living situation	single time point assessment at baseline
Secondary	cost of maintenance of the register	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