Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-18 @ 4:19 PM
Study NCT ID:
NCT03395158
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2017-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Traumalert
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: