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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00164034
Registration number
NCT00164034
Ethics application status
Date submitted
13/09/2005
Date registered
14/09/2005
Date last updated
12/02/2013
Titles & IDs
Public title
Trauma Reception and Resuscitation Project
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Scientific title
Trauma Reception and Resuscitation Project - 'Time for a New Approach'
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Secondary ID [1]
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166/03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Trauma
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Condition category
Condition code
Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Error rate per patient treated demonstrated by deviation from the algorithms
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Missed injuries
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Time to decision
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Assessment method [2]
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Timepoint [2]
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Eligibility
Key inclusion criteria
All injured patients > 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Stable Trauma patients (ie Pulse rate <100/minute, MAP >70mmHg, Hb >70, temperature >35 and <37.5, Spo2 >92%, GCS >13) undergoing secondary transfer from another hospital, where trauma occurred >6hrs prior to arrival.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2008
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Sample size
Target
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Accrual to date
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Final
1171
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital, Emergency and Trauma Centre, . - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Victorian Trauma Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Trauma Research Institute
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients. Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.
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Trial website
https://clinicaltrials.gov/study/NCT00164034
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Trial related presentations / publications
Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.
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Public notes
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Contacts
Principal investigator
Name
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Mark Fitzgerald, MBBS, FACEM, MRCMA
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Address
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The Alfred Hospital, Bayside Health, Melbourne, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00164034
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