Trauma Reception and Resuscitation - 'Time for a New Approach'

ISRCTN	ISRCTN68866227
DOI	https://doi.org/10.1186/ISRCTN68866227
ClinicalTrials.gov (NCT)	NCT00164034
Protocol serial number	N/A
Sponsor	The Victorian Trauma Foundation (Australia)
Funder	The Victorian Trauma Foundation and The Alfred Hospital - Bayside Health

Submission date: 16/02/2005
Registration date: 06/01/2006
Last edited: 31/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mark Fitzgerald
Scientific

The Alfred Hospital Emergency and Trauma Centre
P.O. Box 315
Prahran
3181
Australia

Phone	+61 (0)3 92762782
Email	m.fitzgerald@alfred.org.au

Study information

Primary study design	Interventional
Study design	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Secondary study design	Randomised controlled trial
Scientific title	Trauma resuscitation errors and computer-assisted decision support.
Study acronym	TR&RP
Study objectives	The introduction of real-time computer prompted algorithms will result in a measurable reduction in management errors associated with reception and resuscitation of major trauma patients, demonstrating that a reduction in management errors translates into a reduction in morbidity and mortality.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Traumatic injury
Intervention	A historical control to assess the Hawthorne effect. A randomised controlled trial comparing trauma resuscitation supported by real-time computer prompted algorithms against those without.
Intervention type	Other
Primary outcome measure(s)	The primary benefits will be: 1. The development of evidence-based algorithms for trauma resuscitation 2. The development of real-time, computer aided, data collection during trauma resuscitation 3. Testing the hypothesis that the introduction of real-time, computer-prompted algorithms will result in a measurable reduction in management errors associated with reception and resuscitation of major trauma patients 4. Demonstrating that a reduction in management errors translates into a reduction in morbidity and mortality
Key secondary outcome measure(s)	The secondary benefits will be: 1. Standardising, publishing and distributing resuscitation documentation, interventions and diagnoses 2. Critical evaluation of the cost-benefit of trauma resuscitation video audit 3. Rejuvenation of resuscitation research through the development of a standardised environment
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1162
Key inclusion criteria	1162 test and control trauma cases presenting to the Trauma Centre of the Alfred Hospital.
Key exclusion criteria	Stable trauma patients (i.e. pulse rate <100/minute, mean arterial pressure [MAP] >70 mmHg, Hb >70, temperature >35 °C and <37.5 °C, SpO2 >92%, Glasgow Coma Score [GCS] >13) undergoing secondary transfer from another hospital, where trauma occurred >6 hours prior to arrival, will be excluded.
Date of first enrolment	01/01/2005
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Australia

Study participating centre

The Alfred Hospital Emergency and Trauma Centre

Prahran
3181
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2006		Yes	No
Results article	results	01/02/2011	31/01/2019	Yes	No

Editorial Notes

31/01/2019: Publication reference added