NCT03395158

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

December 15, 2017

Last Update Submit

January 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of alerts initiated

    The total number of trauma alerts initiated in the study group

    One year data with intervention

Secondary Outcomes (1)

  • Analysis of over- and undertriage with the Matrix method

    One year data with intervention

Study Arms (2)

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

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

Present alert criteriaPrior alert criteria

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Kevin Mani, Ass prof

    Uppsala University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

January 10, 2018

Study Start

June 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share