Abstract
INTRODUCTION: Management of traumatic brain injury (TBI) includes invasive monitoring to prevent secondary brain injuries. Intracranial pressure (ICP) monitor is the main measurement used to that intent but cerebral hypoxia can occur despite normal ICP. This study will assess whether the addition of a brain tissue oxygenation (PbtO(2)) monitor prevents more secondary injuries that will translate into improved functional outcome. METHODS AND ANALYSIS: Multicentre, randomised, blinded-endpoint comparative effectiveness study enrolling 1094 patients with severe TBI monitored with both ICP and PbtO(2). Patients will be randomised to medical management guided by ICP alone (treating team blinded to PbtO(2) values) or both ICP and PbtO(2). Management is protocolised according to international guidelines in a tiered approach fashion to maintain ICP <22 mm Hg and PbtO(2) >20 mm Hg. ICP and PbtO(2) will be continuously recorded for a minimum of 5 days. The primary outcome measure is the Glasgow Outcome Scale-Extended performed at 180 (±30) days by a blinded central examiner. Favourable outcome is defined according to a sliding dichotomy where the definition of favourable outcome varies according to baseline severity. Severity will be defined according to the probability of poor outcome predicted by the IMPACT core model. A large battery of secondary outcomes including granular neuropsychological and quality of life measures will be performed. ETHICS AND DISSEMINATION: This has been approved by Advarra Ethics Committee (Pro00030585). Results will be presented at scientific meetings and published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03754114).