Trauma Reception and Resuscitation - 'Time for a New Approach'
| ISRCTN | ISRCTN68866227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68866227 |
| ClinicalTrials.gov number | NCT00164034 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Prof Mark Fitzgerald
Scientific
Scientific
The Alfred Hospital Emergency and Trauma Centre
P.O. Box 315
Prahran
3181
Australia
| Phone | +61 (0)3 92762782 |
|---|---|
| m.fitzgerald@alfred.org.au |
Study information
| Study design | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Trauma resuscitation errors and computer-assisted decision support. |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2005 |
| Overall study end date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1162 |
| Participant inclusion criteria | 1162 test and control trauma cases presenting to the Trauma Centre of the Alfred Hospital. |
| 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
Study participating centre
The Alfred Hospital Emergency and Trauma Centre
Prahran
3181
Australia
3181
Australia
Sponsor information
The Victorian Trauma Foundation (Australia)
Charity
Charity
P.O. Box 2751
Melbourne
3001
Australia
| Phone | +61 (0)3 96646563 |
|---|---|
| vtf@vtf.com.au |
Funders
Funder type
Charity
The Victorian Trauma Foundation and The Alfred Hospital - Bayside Health
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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
