About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Clinical diagnosis of moderate to severe TBI
Insertion of invasive intra-cranial monitoring
Study inclusion within 48 hours of ICU admission
Disqualifiers
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
Trial population
moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Mortality
Death occurring any time between date of hospital admission and 6 months post-injury (up to 180 days post-injury)
Hospital length of stay
Number of acute hospital admission days
Intensive care Unit (ICU) length of stay
Number of ICU admission days
EuroQol (EQ-5D five-level)
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).
Sponsors and contacts
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