Brain oxygen monitoring in severe traumatic brain injury
Research type
Research Study
Full title
Brain Oxygen Neuromonitoring In Australia and New Zealand Assessment Trial - The BONANZA Trial
IRAS ID
301637
Contact name
John Porter
Contact email
Sponsor organisation
Australian and New Zealand Intensive Care Research Centre
Clinicaltrials.gov Identifier
ACTRN12619001328167P, Australian New Zealand Clinical Trials Registry
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Traumatic brain injury (TBI) is a leading cause of death and long-term disability. Approximately half of those with severe traumatic brain injury will be severely disabled or dead 6 months post injury. Given the young age of many patients with severe TBI, the economic and more importantly the social cost to the community is very high.
Management of patients with brain injuries focusses on the prevention of “secondary” brain injury. This can result from complications of the injury such as insufficient blood flow, or insufficient oxygen in the brain. The mainstay of preventing secondary injury has been the management of patients in the intensive care unit (ICU), with treatment aimed at minimising any rise in intracranial pressure (ICP) and maintaining blood flow. However, rises in ICP may be a late indicator of secondary injury
The brain depends on an uninterrupted supply of oxygen and monitoring the oxygen levels in brain tissue may provide a more useful marker of secondary injury. Several small trials have provided some promising results to support the use of monitoring and optimising brain tissue oxygenation to minimise secondary brain injury.
There have been no robust clinical trials to provide evidence to support the use of this technology. Clinicians are uncertain about the benefit of monitoring brain tissue oxygen levels. This important question would be answered by a trial testing this strategy compared to the standard management of monitoring ICP alone.
The BONANZA trial will enrol 860 patients who have suffered a severe TBI and require ICP monitoring. Each patient will be randomised to either a brain tissue oxygen monitoring strategy (including ICP monitoring) or the standard strategy of ICP monitoring alone. Functional and neurological recovery will be assessed at 6 months post injury to see if there is a difference between both groups of patients.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0216
Date of REC Opinion
20 Sep 2021
REC opinion
Favourable Opinion