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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Andrew Udy, MB,FCICM,PhD contact

+61 (03) 9903 0343

andrew.udy@monash.edu

Camila Battistuzzo, PhD contact

+61 0422 020 126

camila.battistuzzo@monash.edu

9 sites in 1 country

Australia9 sites, 9 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

    Recruiting

Other trials in Australia

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.

  1. 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)
  1. 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

  2. Hospital length of stay

    Number of acute hospital admission days

    Measured: Through study completion, an average of 1 year

  3. Intensive care Unit (ICU) length of stay

    Number of ICU admission days

    Measured: Through study completion, an average of 1 year

  4. 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.

  1. First posted11 May 2023
  2. Study start14 Aug 2022
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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)
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

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.

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