NCT05855252 PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury
| NCT ID | NCT05855252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Australian and New Zealand Intensive Care Research Centre |
| Condition | Trauma, Brain |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-08-14 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-08-14 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Andrew Udy, MB,FCICM,PhD
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT05855252 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05855252 currently recruiting?
Yes, NCT05855252 is actively recruiting participants. Contact the research team at andrew.udy@monash.edu for enrollment information.
Where is the NCT05855252 trial being conducted?
This trial is being conducted at Kogarah, Australia, New Lambton Heights, Australia, St Leonards, Australia, Westmead, Australia and 5 additional locations.
Who is sponsoring the NCT05855252 clinical trial?
NCT05855252 is sponsored by Australian and New Zealand Intensive Care Research Centre. The principal investigator is Andrew Udy, MB,FCICM,PhD at Monash University. The trial plans to enroll 300 participants.