ANZICS CTG Endorsed Study
Brain Oxygen Neuromonitoring in Australia and New Zealand – Global Trial
Study Description
Severe traumatic brain injury (TBI) is a leading cause of morbidity and mortality, particularly in young adults, where 50% of survivors cannot live independently six months post injury. TBI also disproportionately effects Indigenous Australians, with hospitalisation rates due to head injury 21-fold that of non-Indigenous peoples. Given the age demographic and the high prevalence of long-term disability, the social and economic costs of severe brain injury are extremely high; the life-time financial cost of caring for Australian TBI survivors approaches 5 Billion AUD annually.
Our goal is to improve outcomes post severe TBI and reduce long-term healthcare costs, by conducting a large (n=860), pragmatic, patient-centred randomised controlled trial of a neuro-intensive care management protocol based on early brain tissue oxygen optimisation. After primary brain trauma, modern neuro-intensive care is focused on preventing secondary brain injury, which can significantly impact long-term functional outcomes. Clinical monitoring has traditionally focused on measuring intra-cranial pressure (ICP), and optimizing cerebral perfusion pressure (CPP), although these are insensitive to changes in cerebral oxygenation. This is crucial, as neuronal health depends on a constant supply of oxygen, and brain ischaemia is a consistent finding in patients who manifest poor outcomes. In comparison to standard ICP/CPP based care, our trial will assess the value of additional continuous monitoring of the partial pressure of brain tissue oxygen, in combination with a stepwise algorithm that can be instituted when cerebral oxygenation is noted to be impaired. Current data (including feasibility work at our institution) suggests this approach reduces the cerebral hypoxic burden post TBI and may improve clinical outcomes. Our study will run in parallel with the NIH funded BOOST 3 study conducted in USA. The studies will be harmonized and an IPDMA is planned.
Management Committee
Andrew Udy, Alex Adamides, Alistair Nichol, Anthony Delaney, Benjamin Reddi, David Menon, Fabio Taccone, James Anstey, Jamie Cooper, Jeffrey Rosenfeld, Jean Francois Payen, Judith Bellapart, Kate Drummond, Kathleen Byrne, Lisa Higgins, Lynne Murray, Martin Hunn, Matthias Hangii, Olivier Huet, Patricia Villodre Alliegro, Phil Lewis, Shirley Vallance, Stephan Jakob, Tony Trapani
Administering Institution
Monash University
Sample Size
860 patients
Funding
NHMRC, MRFF, Belgium Grant, Ireland Grant
Reference
CTG1718-05, ACTRN12619001328167
Contact
Patricia Villodre Alliegro (email)