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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2017-12-15', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of alerts initiated', 'timeFrame': 'One year data with intervention', 'description': 'The total number of trauma alerts initiated in the study group'}], 'secondaryOutcomes': [{'measure': 'Analysis of over- and undertriage with the Matrix method', 'timeFrame': 'One year data with intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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.\n\nThe including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.\n\nThe registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017\n\nExclusion Criteria:\n\n* Patients registered due to secondary referral where the initial assessment was performed at another hospital'}, 'identificationModule': {'nctId': 'NCT03395158', 'acronym': 'Traumalert', 'briefTitle': 'Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage', 'orgStudyIdInfo': {'id': 'UppsalaUH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prior alert criteria', 'description': 'Patients who activated full, limited or no alert criteria according to the prior alert criteria', 'interventionNames': ['Diagnostic Test: Implementation of new alert criteria']}, {'label': 'Present alert criteria', 'description': 'Patients who activated full, limited or no alert criteria according to the present alert criteria', 'interventionNames': ['Diagnostic Test: Implementation of new alert criteria']}], 'interventions': [{'name': 'Implementation of new alert criteria', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention is when the prior alert criteria are replaced by the present alert criteria', 'armGroupLabels': ['Present alert criteria', 'Prior alert criteria']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kevin Mani, Ass prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala-Örebro Regional Research Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}