Trauma, BrainNCT05855252
PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury
An observational study of Trauma, Brain, run by Australian and New Zealand Intensive Care Research Centre at 9 sites in Australia.
Trial summary
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Brain
- How many people
- 300 participants
- Where
- 9 sitesAustralia
- Study dates
- 14 Aug 2022to 1 Jul 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.
Who may be able to join
- Age ≥18 years
- Clinical diagnosis of moderate to severe TBI
- Insertion of invasive intra-cranial monitoring
- Study inclusion within 48 hours of ICU admission
Who cannot join
- Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
- Advanced care directive or previously stated wish not to be included in research activities
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites, 9 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Mark Plummer, MBBS PhD, +61 (08) 7074 1800, mark.plummer@sa.gov.au
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Shailesh Bihari, +61 (08) 8204 4308, biharishailesh@gmail.com
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Judith Bellabart, +61 (07) 3646 8111, judith.bellapart@health.qld.gov.au
- Recruiting
St George Hospital
Kogarah, New South Wales, 2217
Mark Weeden, +61 (02) 9113 3227, mcweeden@gmail.com
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Dominic Jeffcote, MB, PhD, +61 (03) 9903 0343, d.jeffcote@alfred.org.au
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3052
James Anstey, +61 (03) 9342 7000, james.anstey@mh.org.au
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Andrew Chow, +61 (02) 4921 4254, andrew.chow@health.nsw.gov.au
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Anthony Delaney, +61 (02) 9463 2633, anthony.delaney@sydney.edu.au
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
David Bowen, +61 (02) 8890 9343, david.bowen@health.nsw.gov.au
About this study
Official title: PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.
Read the detailed description
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of death and long-term disability, particularly in young adults. In Australia and New Zealand, severe TBI accounts for over 700 intensive care unit (ICU) admissions per year. Approximately half of these patients will die or be severely disabled six months after their injury. The lifetime costs for the disabled survivors of TBI reach an estimated $1 billion annually. There are strong ethical, medical, social and health economic reasons to improve treatment and reduce disability in TBI.
TBI is a broad term for many different types of injuries to the brain. This study focuses on the most severe types of TBI that require hospital management and ICU care - moderate to severe TBI (m-sTBI). The fact that every patient with m-sTBI is different, has a different type of injury and is treated differently from hospital to hospital makes it very difficult to study m-sTBI and identify the most effective treatments for improving patient outcomes. At the moment, there is only a small amount of data on how m-sTBI patients are treated in the different hospitals in Australia and whether there are differences in outcomes associated with different approaches to m-sTBI management. Currently there is no central database for m-sTBI patients in Australia that can be used to compare different hospitals and track progress over time.
The first aim of PRECISION-TBI is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. High quality data about the initial injury (cause, severity and presence of factors that may make the injury worse), the early management of the patient (e.g. time to arrival at hospital), the surgical management of the patient (surgeries undertaken and monitoring probes utilised), the clinical management in ICU and neurological outcome after the injury will be collected. The main focus will be on the ICU management of m-sTBI so participating sites will be provided with computers and specialist software to collect accurate minute to minute data from brain monitors used to guide patient management in the ICU. Recovery at 6 months post-injury will be collected for all enrolled participants to understand how different injuries and treatments have affected long term patient outcomes.
The participating hospitals will also be provided with feedback on the characteristics of their m-sTBI patient population, the treatments that they are using and the outcomes for their patients. It will be possible for participating hospitals to compare each of these parameters with other similar hospitals and this will allow the identification of any factors that are strongly associated with improved patient outcomes. This will be provided over the course of at least 2 years, which will allow hospitals to track progress over time and identify how changes to management protocols and care systems may result in better outcomes for patients in this highly vulnerable group.
- Conditions
- Trauma, Brain
- Being tested
- No intervention
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow outcome scale
Unfavourable outcome at 6 months post-injury (defined as a score of 4 or less on the 8-point extended Glasgow outcome scale)
Measured: At 6 months post-injury
Secondary outcomes (4)
Mortality
Death occurring any time between date of hospital admission and 6 months post-injury (up to 180 days post-injury)
Measured: Up to 6 months post-injury
Hospital length of stay
Number of acute hospital admission days
Measured: Through study completion, an average of 1 year
Intensive care Unit (ICU) length of stay
Number of ICU admission days
Measured: Through study completion, an average of 1 year
EuroQol (EQ-5D five-level)
Quality of life questionnaire, each of the 5 questions is scored from 1 (no problem performing that particular task) to 5 (unable to perform the task).
Measured: At 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start14 Aug 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
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 Trauma, BrainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Udy, MB,FCICM,PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855252
- Sponsor's protocol ID
- ANZIC-RC/AU001
- Status last verified
- Aug 2024
- First submitted
- 28 Mar 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeffcote T, Battistuzzo CR, Plummer MP, McNamara R, Anstey J, Bellapart J, Roach R, Chow A, Westerlund T, Delaney A, Bihari S, Bowen D, Weeden M, Trapani A, Reade M, Jeffree RL, Fitzgerald M, Gabbe BJ, O'Brien TJ, Nichol AD, Cooper DJ, Bellomo R, Udy A. PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia. BMJ Open. 2024 Feb 21;14(2):e080614. doi: 10.1136/bmjopen-2023-080614.
PubMed 38387978
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05855252
- Acronym / sponsor ID
- ANZIC-RC/AU001
- Conditions
- Trauma, Brain
- Keywords
- traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 May 2023 (actual)
- 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.
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.
Detailed description
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of death and long-term disability, particularly in young adults. In Australia and New Zealand, severe TBI accounts for over 700 intensive care unit (ICU) admissions per year. Approximately half of these patients will die or be severely disabled six months after their injury. The lifetime costs for the disabled survivors of TBI reach an estimated $1 billion annually. There are strong ethical, medical, social and health economic reasons to improve treatment and reduce disability in TBI.
TBI is a broad term for many different types of injuries to the brain. This study focuses on the most severe types of TBI that require hospital management and ICU care - moderate to severe TBI (m-sTBI). The fact that every patient with m-sTBI is different, has a different type of injury and is treated differently from hospital to hospital makes it very difficult to study m-sTBI and identify the most effective treatments for improving patient outcomes. At the moment, there is only a small amount of data on how m-sTBI patients are treated in the different hospitals in Australia and whether there are differences in outcomes associated with different approaches to m-sTBI management. Currently there is no central database for m-sTBI patients in Australia that can be used to compare different hospitals and track progress over time.
The first aim of PRECISION-TBI is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. High quality data about the initial injury (cause, severity and presence of factors that may make the injury worse), the early management of the patient (e.g. time to arrival at hospital), the surgical management of the patient (surgeries undertaken and monitoring probes utilised), the clinical management in ICU and neurological outcome after the injury will be collected. The main focus will be on the ICU management of m-sTBI so participating sites will be provided with computers and specialist software to collect accurate minute to minute data from brain monitors used to guide patient management in the ICU. Recovery at 6 months post-injury will be collected for all enrolled participants to understand how different injuries and treatments have affected long term patient outcomes.
The participating hospitals will also be provided with feedback on the characteristics of their m-sTBI patient population, the treatments that they are using and the outcomes for their patients. It will be possible for participating hospitals to compare each of these parameters with other similar hospitals and this will allow the identification of any factors that are strongly associated with improved patient outcomes. This will be provided over the course of at least 2 years, which will allow hospitals to track progress over time and identify how changes to management protocols and care systems may result in better outcomes for patients in this highly vulnerable group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Clinical diagnosis of moderate to severe TBI
- Insertion of invasive intra-cranial monitoring
- Study inclusion within 48 hours of ICU admission
Key exclusion criteria (2 listed)
- Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
- Advanced care directive or previously stated wish not to be included in research activities
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Glasgow outcome scale
Time frame: At 6 months post-injury
Unfavourable outcome at 6 months post-injury (defined as a score of 4 or less on the 8-point extended Glasgow outcome scale)
4 secondary outcomes
Mortality
Time frame: Up to 6 months post-injury
Hospital length of stay
Time frame: Through study completion, an average of 1 year
Intensive care Unit (ICU) length of stay
Time frame: Through study completion, an average of 1 year
EuroQol (EQ-5D five-level)
Time frame: At 6 months post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 38387978Jeffcote T, Battistuzzo CR, Plummer MP, McNamara R, Anstey J, Bellapart J, Roach R, Chow A, Westerlund T, Delaney A, Bihari S, Bowen D, Weeden M, Trapani A, Reade M, Jeffree RL, Fitzgerald M, Gabbe BJ, O'Brien TJ, Nichol AD, Cooper DJ, Bellomo R, Udy A. PRECISION-TBI: a study protocol for a vanguard prospective cohort study to enhance understanding and management of moderate to severe traumatic brain injury in Australia. BMJ Open. 2024 Feb 21;14(2):e080614. doi: 10.1136/bmjopen-2023-080614.
- Individual participant dataSharing planned: No
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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.
Andrew Udy, MB,FCICM,PhD principal investigator
Monash University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Brain, run by Australian and New Zealand Intensive Care Research Centre at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Udy, MB,FCICM,PhD (+61 (03) 9903 0343, andrew.udy@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow outcome scale (time frame: At 6 months post-injury). 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 NCT05855252, 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 Aug 2024.