TraumaNCT00164034
Trauma Reception and Resuscitation Project
A study testing Real time computer prompted trauma algorithms in people with Trauma, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Real time computer prompted trauma algorithms
- Type of treatment
- Medical device
- How many people
- 1,171 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Alfred Hospital, Emergency and Trauma Centre, .
Melbourne, Victoria, 3004
About this study
Official title: Trauma Reception and Resuscitation Project - 'Time for a New Approach'
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.
- Conditions
- Trauma
- Being tested
- Real time computer prompted trauma algorithms
- Keywords
- Trauma, Wounds, Injuries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time computer prompted trauma algorithmsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Error rate per patient treated demonstrated by deviation from the algorithms
Secondary outcomes (2)
Missed injuries
Time to decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Victorian Trauma Foundation, National Trauma Research Institute
- Responsible party
- Sponsor
- Investigators
- Mark Fitzgerald, MBBS, FACEM, MRCMA, Principal investigator, The Alfred Hospital, Bayside Health, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164034
- Sponsor's protocol ID
- 166/03
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 12 Feb 2013
- Results posted
- No
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.
PubMed 21339436
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Reception and Resuscitation Project - 'Time for a New Approach'
- ClinicalTrials.gov ID
- NCT00164034
- Acronym / sponsor ID
- 166/03
- Conditions
- Trauma
- Keywords
- Trauma, Wounds, Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,171 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Victorian Trauma Foundation, National Trauma Research Institute
- Study start
- Nov 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real time computer prompted trauma algorithms | Device | – |
Primary outcome
Error rate per patient treated demonstrated by deviation from the algorithms
2 secondary outcomes
Missed injuries
Time to decision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Derived from this study: PubMed 21339436Fitzgerald 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.
- National Trauma Research InstituteLink provided by the sponsor.
- The Alfred Hospital, Melbourne, Victoria, Australia.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fitzgerald, MBBS, FACEM, MRCMA principal investigator
The Alfred Hospital, Bayside Health, Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real time computer prompted trauma algorithms in people with Trauma, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error rate per patient treated demonstrated by deviation from the algorithms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00164034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.