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Trauma Reception and Resuscitation Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164034
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 12, 2013
Sponsor:
Collaborators:
Victorian Trauma Foundation
National Trauma Research Institute
Information provided by (Responsible Party):
Bayside Health

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date February 12, 2013
Study Start Date  ICMJE November 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Error rate per patient treated demonstrated by deviation from the algorithms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Missed injuries
  • Time to decision
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trauma Reception and Resuscitation Project
Official Title  ICMJE Trauma Reception and Resuscitation Project - 'Time for a New Approach'
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trauma
Intervention  ICMJE Device: Real time computer prompted trauma algorithms
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2013)
1171
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
1162
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: All injured patients > 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164034
Other Study ID Numbers  ICMJE 166/03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayside Health
Study Sponsor  ICMJE Bayside Health
Collaborators  ICMJE
  • Victorian Trauma Foundation
  • National Trauma Research Institute
Investigators  ICMJE
Principal Investigator: Mark Fitzgerald, MBBS, FACEM, MRCMA The Alfred Hospital, Bayside Health, Melbourne, Australia
PRS Account Bayside Health
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP