TraumaNCT03999346
Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes
An observational study of Trauma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- retrospective analysis of the Swiss Trauma Registry data
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- documentation in the STR
- Injury Severity Score (ISS) ≥ 16
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Trauma Surgery (DOTS).
Basel, 4031
About this study
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.
- Conditions
- Trauma
- Being tested
- retrospective analysis of the Swiss Trauma Registry data
- Keywords
- Swiss Polytrauma Registry, quality control, standardized identification procedures, data capture
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysis of the Swiss Trauma Registry dataOther
retrospective analysis of protectively documented registry data based on data completeness, patient outcomes, patient characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: single time point assessment at baseline
rate of 28 day survival
analysis of patient outcome: rate of patients' 28 day survival
Measured: single time point assessment at baseline
length of hospital stay
analysis of patient outcome: length of hospital stay (days)
Measured: single time point assessment at baseline
rate of patients receiving intensive care treatment
analysis of patient outcome: rate of patients receiving intensive care treatment
Measured: 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
Measured: single time point assessment at baseline
Secondary outcomes (1)
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
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Nov 2018
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Bless, Dr. med, Principal investigator, Department Orthopedic and Trauma Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999346
- Sponsor's protocol ID
- 2018-01907; ch19Bless
- Other IDs
- 2018
- Status last verified
- Dec 2019
- First submitted
- 24 Jun 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes
- ClinicalTrials.gov ID
- NCT03999346
- Acronym / sponsor ID
- 2018-01907; ch19Bless
- Conditions
- Trauma
- Keywords
- Swiss Polytrauma Registry, quality control, standardized identification procedures, data capture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- documentation in the STR
- Injury Severity Score (ISS) ≥ 16
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective analysis of the Swiss Trauma Registry dataretrospective analysis of protectively documented registry data based on data completeness, patient outcomes, patient characteristics | Other | – |
Primary outcome
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).
rate of 28 day survival
Time frame: single time point assessment at baseline
analysis of patient outcome: rate of patients' 28 day survival
length of hospital stay
Time frame: single time point assessment at baseline
analysis of patient outcome: length of hospital stay (days)
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
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
1 secondary outcome
cost of maintenance of the register
Time frame: single time point assessment at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Bless, Dr. med principal investigator
Department Orthopedic and Trauma Surgery, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of data completeness (time frame: single time point assessment at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.