NCT03999346

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

June 24, 2019

Last Update Submit

December 17, 2019

Conditions

Keywords

Swiss Polytrauma Registryquality controlstandardized identification proceduresdata capture

Outcome Measures

Primary Outcomes (5)

  • 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

  • rate of 28 day survival

    analysis of patient outcome: rate of patients' 28 day survival

    single time point assessment at baseline

  • length of hospital stay

    analysis of patient outcome: length of hospital stay (days)

    single time point assessment at baseline

  • rate of patients receiving intensive care treatment

    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

    analysis of patient outcome: rate of patients returning to the previous living situation

    single time point assessment at baseline

Secondary Outcomes (1)

  • cost of maintenance of the register

    single time point assessment at baseline

Interventions

retrospective analysis of protectively documented registry data based on data completeness, patient outcomes, patient characteristics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Nicolas Bless, Dr. med

    Department Orthopedic and Trauma Surgery, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

November 1, 2018

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations