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CompletedNCT03395158TraumalertUpdated Jan 10, 2018

Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.

An observational study in Trauma Injury, sponsored by Uppsala University. Completed. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,200
Sex
All
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Study summary

New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. The Swedish trauma registry is used to identify eligible patients.

Read the detailed description

The Swedish trauma registry (SweTrau) was initiated in 2011, and has up to date 40.000 registered patients. In order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the Uppsala/Örebro region. These hospitals register in SweTrau and all had the same alert criteria prior to the implementation of new alert criteria.

A power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% CI.

The including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.

The registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.

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Conditions studied

  • Trauma Injury

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03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's enrollment of 2,200 is above the median of 170 across 59 observational studies indexed under Accidental Injuries.

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Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients subject to trauma where a trauma alert was initiated OR registered patients subject to trauma without an alert call, but with an Injury Severity Score >15.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017

Exclusion criteria

Exclusion Criteria:

  • Patients registered due to secondary referral where the initial assessment was performed at another hospital
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,200 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Prior alert criteria

    Patients who activated full, limited or no alert criteria according to the prior alert criteria

    Diagnostic Test: Implementation of new alert criteria

  • Present alert criteria

    Patients who activated full, limited or no alert criteria according to the present alert criteria

    Diagnostic Test: Implementation of new alert criteria

Interventions

  • Diagnostic testImplementation of new alert criteria

    The intervention is when the prior alert criteria are replaced by the present alert criteria

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What researchers measure

Primary outcomes

  1. Number of alerts initiated

    The total number of trauma alerts initiated in the study group

    Time frame: One year data with intervention

Secondary outcomes

  1. Analysis of over- and undertriage with the Matrix method

    Analyse proportions of patients subject to a full trauma team activation who have an injury severity score \<15 (overtriage). Analyse proportion of patients who do not initiate a full trauma team activation but have an injury severity score \>15 (undertriage) The Matrix method is a well defined method for analysing resource allocation in trauma triage.

    Time frame: One year data with intervention

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Nov 2017, 17 months.

Of 33 non-industry observational studies under Accidental Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 17 months is below that.

Counting every sponsor, half of 39 studies reached it within 31 months; a quarter within 12 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2017
First posted
Jan 10, 2018
StartActual
Jun 1, 2016
Primary completionActual
Nov 1, 2017
CompletionActual
Nov 1, 2017
Last update
Jan 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03395158
Lead sponsor
Uppsala University
Collaborators
Uppsala-Örebro Regional Research Council
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Jun 1, 2016
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Jan 10, 2018

Study contacts

Kevin Mani, Ass prof
study chair · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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