PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury

August 8, 2024 updated by: Australian and New Zealand Intensive Care Research Centre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Contact:
      • New Lambton Heights, New South Wales, Australia, 2305
      • St Leonards, New South Wales, Australia, 2065
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Herston, Queensland, Australia, 4006
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
      • Melbourne, Victoria, Australia, 3052
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow outcome scale
Time Frame: At 6 months post-injury
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 6 months post-injury
Death occurring any time between date of hospital admission and 6 months post-injury (up to 180 days post-injury)
Up to 6 months post-injury
Hospital length of stay
Time Frame: Through study completion, an average of 1 year
Number of acute hospital admission days
Through study completion, an average of 1 year
Intensive care Unit (ICU) length of stay
Time Frame: Through study completion, an average of 1 year
Number of ICU admission days
Through study completion, an average of 1 year
EuroQol (EQ-5D five-level)
Time Frame: At 6 months post-injury
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).
At 6 months post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Australian and New Zealand Intensive Care Research Centre

Investigators

  • Principal Investigator: Andrew Udy, MB,FCICM,PhD, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZIC-RC/AU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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