PRECISION-TBI - An 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
1 other identifier
observational
300
1 country
9
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2022
CompletedFirst Submitted
Initial submission to the registry
March 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedAugust 12, 2024
August 1, 2024
2.6 years
March 28, 2023
August 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
At 6 months post-injury
Secondary Outcomes (4)
Mortality
Up to 6 months post-injury
Hospital length of stay
Through study completion, an average of 1 year
Intensive care Unit (ICU) length of stay
Through study completion, an average of 1 year
EuroQol (EQ-5D five-level)
At 6 months post-injury
Interventions
No intervention
Eligibility Criteria
moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.
You may qualify if:
- Age ≥18 years
- Clinical diagnosis of moderate to severe TBI
- Insertion of invasive intra-cranial monitoring
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
St George Hospital
Kogarah, New South Wales, 2217, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3052, Australia
Related Publications (1)
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.
PMID: 38387978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Udy, MB,FCICM,PhD
Monash University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2023
First Posted
May 11, 2023
Study Start
August 14, 2022
Primary Completion
April 1, 2025
Study Completion
July 1, 2025
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share