Brain tissue oxygen monitoring for severe traumatic brain injury: the international multicentre randomised controlled BONANZA-GT study protocol
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Introduction The management of severe traumatic brain injury (sTBI) in the intensive care unit (ICU) is focused on preventing secondary brain insults, by ensuring adequate cerebral perfusion, oxygenation and substrate delivery. Despite optimisation of intracranial pressure (ICP) and cerebral perfusion pressure (CPP) using evidence-based guidelines, brain tissue hypoxia can still occur and is strongly associated with adverse functional outcomes post sTBI. Methods and analysis The Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment – Global Trial (BONANZA-GT) is an international, two-arm, open-label, parallel group, randomised controlled trial comparing sTBI management incorporating early brain tissue oxygen (PbtO 2 ) monitoring and optimisation, with ICP/CPP-based management alone. A total of 860 adults admitted to participating institutions with non-penetrating sTBI and requiring insertion of an ICP monitor (as determined by the treating neurosurgeon) will be enrolled. The primary outcome is the proportion of patients with favourable neurological outcomes, as defined by a Glasgow Outcome Score-Extended (GOS-E) >4, at 6 months following injury. Key secondary outcomes include all-cause mortality at ICU discharge, hospital discharge, adverse events, as well as hospital and ICU length of stay and GOS-E at 12 months. The BONANZA-GT will determine whether a protocolised therapeutic strategy guided by continuous PbtO 2 monitoring in addition to ICP/CPP targets results in improved neurological outcomes when compared with standard care using ICP/CPP-guided management alone. Ethics and dissemination Approval has been obtained from relevant ethics boards in every jurisdiction that is participating in the trial. Inclusion of adults who lack capacity for informed consent will be governed in accordance with the legal requirements of each participating site. Study findings will be presented at scientific meetings and disseminated via peer-review publications. Trial registration number Australian and New Zealand Clinical Trials Registry (ACTRN 12619001328167).
Source: BMJ Open
Authors: Andrew Alexander Udy, Toby Jeffcote, Camila R Battistuzzo, Aideen Sharry, Alexios A Adamides, Kate Ainscough, Patricia V Alliegro, James Anstey, Michael Bailey, Jesús Abelardo Barea-Mendoza, Judith Bellapart, Pierre Bouzat, Kathleen Byrne, Anthony Delaney, Katharine J Drummond, Matthias Haenggi, Leanne M Hays, Alisa Higgins, Olivier Huet, Martin K Hunn, Stephan M Jakob, Philip M Lewis, Kuan-Ying Lu, David Menon, James Moore, Patrick T Murray, John Porter, Benjamin Reddi, Jeffrey V Rosenfeld, Jonathon D Taylor, Anthony Trapani, Shirley Vallance, Stefan Wolf, Jean-Francois Payen, Fabio Silvio Taccone, Alistair Nichol, D James Cooper
Institutions: The Alfred Hospital, Monash University, University College Dublin, The Royal Melbourne Hospital, Hospital Universitario 12 De Octubre, Comunidad de Madrid, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Service, Centre Hospitalier Universitaire de Grenoble, The George Institute for Global Health, University Hospital Zurich, Centre Hospitalier Régional Universitaire de Brest, University of Bern, University of Cambridge, Wellington Hospital, University Hospitals Sussex NHS Foundation Trust, Royal Adelaide Hospital, Auckland City Hospital, Charité - Universitätsmedizin Berlin, Université Libre de Bruxelles
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W4414796253