Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000757617
Ethics application status
Approved
Date submitted
18/11/2005
Date registered
18/11/2005
Date last updated
10/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Trauma Reception and Resuscitation Project - Time for a new approach
Scientific title
A randomised controlled trial comparing trauma resuscitation supported by real time computer prompted algorithms against those without.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Injury 913 0
Condition category
Condition code
Injuries and Accidents 980 980 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trauma resuscitation supported by real time, computer prompted algorithms. 9 month period of data collection during the intervention period.
Intervention code [1] 765 0
None
Comparator / control treatment
An historical control collected prior to the intervention period to assess for the Hawthorne effect. Participants will receive trauma resuscitation not supported by real time, computer prompted algorithms. 9 month period of data collection during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 1302 0
Reduction in error
Timepoint [1] 1302 0
Data will be collected progressively throughout the nine months of video data collection and will be measured at the time of auditing.
Secondary outcome [1] 2329 0
1) Standardising, publishing and distributing resuscitation documentation, interventions and diagnoses.
Timepoint [1] 2329 0
Secondary outcome [2] 2330 0
2) Critical evaluation of the cost-benefit of trauma resuscitation video audit.
Timepoint [2] 2330 0
Secondary outcome [3] 2331 0
3) Rejuvenation of resuscitation research through the development of a standardised environment.
Timepoint [3] 2331 0

Eligibility
Key inclusion criteria
1162 test and control trauma cases presenting to the Trauma Centre of the Alfred Hospital. Stable trauma patients (ie pulse rate <100 bpm, MAP >70 mmHg, Hb >70, temperature > 35 and < 37.5, SpO2 > 92%, GCS >13).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing the secondary transfer from another hospital, where trauma occurred > 6hrs prior to arrival, will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trauma patients will be allocated to a trauma bay on their arrival. This will be in sequence from T1 - T4. Two bays have the computer sysytem and two do not.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1077 0
Charities/Societies/Foundations
Name [1] 1077 0
TAC Health Research
Country [1] 1077 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Victorian Trauma Foundation
Address
Country
Australia
Secondary sponsor category [1] 938 0
Hospital
Name [1] 938 0
The Alfred Hospital
Address [1] 938 0
Commercial Road, Melbourne, VICTORIA
Country [1] 938 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36400 0
Address 36400 0
Country 36400 0
Phone 36400 0
Fax 36400 0
Email 36400 0
Contact person for public queries
Name 9954 0
Associate Professor Mark Fitzgerald
Address 9954 0
Emergency and Trauma Centre
The Alfred Hospital
Bayside Health
PO Box 315
Prahran VIC 3181
Country 9954 0
Australia
Phone 9954 0
+61 3 92762000
Fax 9954 0
Email 9954 0
[email protected]
Contact person for scientific queries
Name 882 0
Mr Nathan Farrow
Address 882 0
The Alfred Hospital
Bayside Health
PO Box 315
Prahran VIC 3181
Country 882 0
Australia
Phone 882 0
+61 3 92071872
Fax 882 0
+61 3 92071811
Email 882 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.