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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03999346
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 37.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma	Other: retrospective analysis of the Swiss Trauma Registry data

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Dec 12, 2019

Outcome Measures

Primary Outcome Measures

1. analysis of data completeness [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).

2. rate of 28 day survival [single time point assessment at baseline]

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

3. length of hospital stay [single time point assessment at baseline]

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

4. rate of patients receiving intensive care treatment [single time point assessment at baseline]

   analysis of patient outcome: rate of patients receiving intensive care treatment

5. rate of patients returning to the previous living situation [single time point assessment at baseline]

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

Secondary Outcome Measures

1. cost of maintenance of the register [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• documentation in the STR

• Injury Severity Score (ISS) ≥ 16

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopaedics and Trauma Surgery (DOTS).	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03999346
• Other Study ID Numbers: 2018-01907; ch19Bless
• First Posted: Jun 26, 2019
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: Swiss Polytrauma Registry; quality control; standardized identification procedures; data capture
• Additional relevant MeSH terms: Multiple Trauma

Study Results

No Results Posted as of Dec 18, 2019