BONANZA
A randomised controlled trial to test whether a
management strategy guided by early brain tissue oxygen monitoring in patients in with severe traumatic brain injury improves long-term neurological and functional outcomes.
Aim:
The primary aim of this trial is to determine whether a neuro-intensive care management protocol guided by continuous PbtO2 monitoring compared to standard care using ICP monitoring alone increases independent functional and neurological outcomes at 6 and 12-months in patients with severe traumatic brain injury.
Rationale:
Traumatic injury is a global disease with extraordinary human and financial costs. There is substantial evidence, a plausible biological rationale, and supportive evidence from clinical trials to suggest that clinical interventions can attenuate secondary brain injury and reduce mortality and morbidity after TBI in critically ill trauma patients. One such promising intervention is optimisation of the partial pressure of brain tissue oxygen (PbtO2).
Two-thirds of the current TBI management guidelines are based on low-quality evidence, including some of the most fundamental aspects of neuro-intensive care practice. Historically, monitoring of patients with severe TBI has focused on achieving ICP and cerebral perfusion pressure (CPP) targets, in the hope that lowering ICP when it reaches a critical value and providing adequate perfusions pressure, will limit secondary injury. Although this approach has never been validated in a randomized clinical trial, and recent studies have questioned the benefit of ICP-directed therapies, The concept of using continuous PbtO2 monitoring (recently introduced to clinical practice) is that continuously measuring and detecting brain tissue hypoxia will prompt the initiation of therapies to improve tissue oxygenation, resulting in less secondary ischaemic injury, and better outcomes. It has also been reported that most episodes of regional cerebral hypoxia would not have been detected and would have gone untreated using standard monitoring (only 3% of these episodes were associated with an elevated ICP, and only 33% were associated with a CPP <65 mmHg).
Even though some studies may support PbtO2 optimisation, this hypothesis has not been rigorously tested in a powered phase III trial.
Given the lifetime burden of TBI on individuals, families, and the community, additional effective management strategies are of the highest priority.
Study Progress:
The study has been reviewed and approved by the Melbourne Health Human Research Ethics Committee (HREC/55448/MH-2019). Participant recruitment commenced in November 2020.
Trial Registration: This study has been registered with the Australian New Zealand Clinical Trials Registry ACTRN12619001328167.
Endorsement: The study has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG) CTG1617-005.
Further information and Data Entry/CRF: https://www.bonanza.org.au/