ANZICS CTG Endorsed Study

BONANZA

Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment 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 specific set of interventions 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 be one of the first phase III trial of such a management strategy, and will significantly inform TBI management world-wide.

Management Committee

Andrew Udy (Chair), Alex Adamides, James Anstey, Michael Bailey, Judith Bellapart, Kath Byrne, Jamie Cooper, Anthony Delaney, Kate Drummond, Lisa Higgins, Matthias Hangii, Martin Hunn, Stephan Jakob, David Menon, James Moore, Alistair Nichol, Benjamin Reddi, Jeffrey Rosenfeld, Shirley Vallance, Lynne Murray

Administering Institution

Monash University

Sample Size

860 patients

Funding

NHMRC Project Grant: $2,431,862.65
MRFF LSCD Grant: $1,084,852.43

Project Status 

7 active sites, 31 patients recruited to date. 3 further ANZ sites to be initiated shortly.                                                  Brighton Hospital in the UK have submitted to HREC and it is expected that St George in London will also participate.                                                                                                                                                                                    Freiburg in Germany have just submitted to their HREC institution.We have had discussions with Integra regarding some support for European sites. Al Nichol will resubmit the European grant with the addition of agreed support from Integra which should enhance the grant.                                                                                                                        ICM+ software working well and a process for cleaning and curating the data has been established.

Reference

CTG1718-05

Contact

Andrew Udy (email)