TraumaRTSSNCT00876564
Rogaland Trauma System Study
A study testing Trauma patients in people with Trauma, run by Norwegian Air Ambulance Foundation at 1 site in Norway.
Trial summary
The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- Trauma patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,812 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- 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
Who may be able to join
- Included in trauma registry
Who cannot join
- Excluded from trauma registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trauma System Evolution. A Quality Improvement Study of the Trauma System at Stavanger University Hospital, Norway.
The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.
- Conditions
- Trauma
- Being tested
- Trauma patients
- Keywords
- Triage precision
- 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.
Trauma patientsOther
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | Other | Included in trauma registry Receives: Other: Trauma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Over and undertriage
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Air Ambulance Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Rehn, MD, Principal investigator, Norwegian Air Ambulance Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876564
- Sponsor's protocol ID
- 2009/228-CAG(REK)
- Other IDs
- 2009/228-CAG(REK)
- Acronym
- RTSS
- Status last verified
- May 2013
- First submitted
- 3 Apr 2009
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rehn M, Lossius HM, Tjosevik KE, Vetrhus M, Ostebo O, Eken T; Rogaland Trauma System Study Collaborating Group. Efficacy of a two-tiered trauma team activation protocol in a Norwegian trauma centre. Br J Surg. 2012 Feb;99(2):199-208. doi: 10.1002/bjs.7794. Epub 2011 Dec 20.
PubMed 22190166
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma System Evolution. A Quality Improvement Study of the Trauma System at Stavanger University Hospital, Norway.
- ClinicalTrials.gov ID
- NCT00876564
- Acronym / sponsor ID
- RTSS / 2009/228-CAG(REK)
- Conditions
- Trauma
- Keywords
- Triage precision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,812 participants (actual)
- Lead sponsor
- Norwegian Air Ambulance FoundationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Apr 2009 (estimated)
- 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 purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | Other | Other: Trauma patientsIncluded in trauma registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Included in trauma registry
Key exclusion criteria (1 listed)
- Excluded from trauma registry
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 |
|---|---|---|
| Trauma patients | Other | Trauma patients |
Primary outcome
Diagnostic accuracy
Time frame: 7 years
Over and undertriage
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 8 May 2013.
- Derived from this study: PubMed 22190166Rehn M, Lossius HM, Tjosevik KE, Vetrhus M, Ostebo O, Eken T; Rogaland Trauma System Study Collaborating Group. Efficacy of a two-tiered trauma team activation protocol in a Norwegian trauma centre. Br J Surg. 2012 Feb;99(2):199-208. doi: 10.1002/bjs.7794. Epub 2011 Dec 20.
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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.
Marius Rehn, MD principal investigator
Norwegian Air Ambulance Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma patients in people with Trauma, run by Norwegian Air Ambulance Foundation at 1 site in Norway.
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 1 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 8 May 2013. 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 Norway. 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?
Diagnostic accuracy (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876564, which also lists 1 linked publication.
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 8 May 2013.