Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05855252




Registration number
NCT05855252
Ethics application status
Date submitted
28/03/2023
Date registered
11/05/2023
Date last updated
11/05/2023

Titles & IDs
Public title
PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury
Scientific title
PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury
Secondary ID [1] 0 0
ANZIC-RC/AU001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma, Brain 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Other interventions: No intervention
No intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glasgow outcome scale
Timepoint [1] 0 0
At 6 months post-injury
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
Up to 6 months post-injury
Secondary outcome [2] 0 0
Hospital length of stay
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
Intensive care Unit (ICU) length of stay
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
EuroQol (EQ-5D five-level)
Timepoint [4] 0 0
At 6 months post-injury

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05855252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Udy, MB,FCICM,PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Udy, MB,FCICM,PhD
Address 0 0
Country 0 0
Phone 0 0
61 03 9903 0343
Fax 0 0
Email 0 0
andrew.udy@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05855252