Aim: To reduce mortality and disability (improved favourable functional outcomes (Glasgow Outcome Scale-Extended) 6- after severe traumatic brain injury (TBI) in Ireland, Europe and globally.
The Trial: The BONANZA trial; a large (n=860), patient-centred, multicentre definitive intervention study of a neuro-intensive care management strategy of early brain tissue oxygen optimisation.
The Problem: After the initial brain trauma (primary injury) additional brain injury occurs (secondary brain injury) which can significantly affect long-term outcomes of death and severe disability. We aim to reduce this secondary brain injury through a strategy of brain oxygen neuromonitoring and optimisation. Clinical monitoring has traditionally focused on measuring intracranial pressure (ICP), and optimising cerebral perfusion pressure (CPP). These are both insensitive to changes in brain oxygen. Neuronal health depends on a constant supply of oxygen, and in patients with the worst outcomes, brain ischemia is found. In comparison to standard ICP/CPP based care, the BONANZA study will assess the value of additional continuous monitoring of the partial pressure of brain tissue oxygen (PbtO2), in combination with a specific set of interventions that can be instituted when low brain oxygen levels are detected. Some centres use this approach as standard, but this number is currently small. Current data (ours and our collaborators) suggests this approach reduces the cerebral hypoxic burden post-TBI and may improve survival and functional outcomes.
The solution: The BONANZA study will assess this management strategy and guide clinical practice and policy globally with significant impacts whether the approach proves beneficial or not. This funding will allow the conduct of BONANZA in Ireland (all neurosurgical centres) and Europe (funding secured for Australia >AUD$3 million). We have already developed the protocol, the first patients have been recruited in Australia, we have a world renowned investigator team and our established neuro-intensive care networks (>50 ICUs) are committed and ready to deliver this study.
The Impact: If BONANZA demonstrates benefit, it will become the global standard of care benefiting patients, their families, clinicians and reducing healthcare costs. Equipoise currently exists to address this important evidence gap and it is of the utmost urgency that BONANZA addresses this in 2023.
