BONANZA: a randomised controlled trial that is testing 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 (KCE-211323)

Summary (Dutch or French)

Traumatic brain injury (TBI) is a leading cause of death and long-term disability, particularly in young adults.

Studies have shown that approximately half of those with severe TBI will be severely disabled or dead during the months following the initial injury. Given the young age of many patients with severe TBI and the long-term prevalence of major disability, the economic and more importantly the social cost to the community is very high.

The mainstay of managing these patients involves admission to the intensive Care Unit (ICU), and the continuous monitoring of pressure inside the brain (called “ICP monitoring”), with treatment aimed at minimizing any rise in ICP. However, some clinicians feel that rises in ICP may be a late indicator of secondary damage to brain cells as the brain depends on an uninterrupted supply of oxygen and glucose to remain viable and have suggested that monitoring the oxygen levels in brain may provide more useful information. Technology has improved and it is now feasible to monitor oxygen levels so that low oxygen levels can be detected and treatments started promptly that might increase brain tissue oxygenation. This strategy may have the potential to improve long term outcomes. However, there have been no robust clinical trials to definitively support the routine use of this strategy. Clinicians are uncertain about the benefit of monitoring brain tissue oxygen levels. This important question will 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 and subsequent admission to ICU. Each patient will be randomized (like tossing a coin) 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.