Observational study of patients with moderate to severe traumatic brain injury
PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury
This study looks at how different hospitals treat patients with moderate to severe traumatic brain injuries to see how these treatments affect recovery over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre Academic / other |
| Locations | 9 sites (Kogarah, New South Wales and 8 other locations) |
| Trial ID | NCT05855252 on ClinicalTrials.gov |
What this trial studies
This study focuses on collecting data regarding the management of moderate to severe traumatic brain injury (m-sTBI) in various hospitals across Australia. It aims to quantify the variability in treatment approaches and outcomes for patients requiring intensive care. By analyzing recovery data at six months post-injury, the study seeks to enhance understanding of how different injuries and treatments impact long-term recovery. The ultimate goal is to establish a central database to improve treatment strategies and reduce disability associated with m-sTBI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with moderate to severe TBI and require invasive intra-cranial monitoring.
Not a fit: Patients admitted to the ICU solely for palliative care or organ donation confirmation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and better long-term outcomes for patients with traumatic brain injuries.
How similar studies have performed: While there is limited data on the management of m-sTBI in Australia, similar observational studies in other regions have shown promise in identifying effective treatment strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Clinical diagnosis of moderate to severe TBI * Insertion of invasive intra-cranial monitoring * Study inclusion within 48 hours of ICU admission Exclusion Criteria: * 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
Where this trial is running
Kogarah, New South Wales and 8 other locations
- St George Hospital — Kogarah, New South Wales, Australia (Recruiting)
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Andrew Udy, MB,FCICM,PhD — Monash University
- Study coordinator: Andrew Udy, MB,FCICM,PhD
- Email: andrew.udy@monash.edu
- Phone: +61 (03) 9903 0343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.