Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/02/2005
Date assigned
06/01/2006
Last edited
29/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Fitzgerald

ORCID ID

Contact details

The Alfred Hospital Emergency and Trauma Centre
P.O. Box 315
Prahran
3181
Australia
+61 (0)3 92762782
m.fitzgerald@alfred.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00164034

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TR&RP

Study hypothesis

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

Not provided at time of registration

Study design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1162 test and control trauma cases presenting to the Trauma Centre of the Alfred Hospital.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1162

Participant 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.

Recruitment start date

01/01/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Australia

Trial participating centre

The Alfred Hospital Emergency and Trauma Centre
Prahran
3181
Australia

Sponsor information

Organisation

The Victorian Trauma Foundation (Australia)

Sponsor details

P.O. Box 2751
Melbourne
3001
Australia
+61 (0)3 96646563
vtf@vtf.com.au

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

The Victorian Trauma Foundation and The Alfred Hospital - Bayside Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Fitzgerald, M, Dzuikas, L, Cameron, P, Mackenzie, C and Farrow, N (2005) Trauma Reception and Resuscitation. Canadian Journal of Surgery.

2. Trauma Reception and Resuscitation Project - 'Time for a New Approach' Operational Summary for the Victorian Trauma Foundation Best Practice Program Grant. A/Professor Mark Fitzgerald Emergency and Trauma Centre, The Alfred. 13 December 2004. (Unpublished work).

Publication citations

Additional files

Editorial Notes