{
  "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 PbtO2 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).",
  "authors": [
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia",
        "Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Andrew Alexander Udy"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia",
        "Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Toby Jeffcote"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Camila R Battistuzzo"
    },
    {
      "affiliations": [
        "Clinical Research Centre, University College Dublin, Dublin, Ireland"
      ],
      "name": "Aideen Sharry"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Alexios A Adamides"
    },
    {
      "affiliations": [
        "Clinical Research Centre, University College Dublin, Dublin, Ireland"
      ],
      "name": "Kate Ainscough"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Patricia V Alliegro"
    },
    {
      "affiliations": [
        "Department of Intensive Care, The Royal Melbourne Hospital, Parkville, Victoria, Australia"
      ],
      "name": "James Anstey"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Michael Bailey"
    },
    {
      "affiliations": [
        "Intensive Care Unit, Hospital Universitario 12 de Octubre, Madrid, Comunidad de Madrid, Spain"
      ],
      "name": "Jesús Abelardo Barea-Mendoza"
    },
    {
      "affiliations": [
        "Royal Brisbane and Women’s Hospital, Metro North Health, Queensland, Australia"
      ],
      "name": "Judith Bellapart"
    },
    {
      "affiliations": [
        "Department of Anaesthesia and Intensive Care, Centre Hospitalier Universitaire de Grenoble, Grenoble, France"
      ],
      "name": "Pierre Bouzat"
    },
    {
      "affiliations": [
        "Department of Intensive Care, The Royal Melbourne Hospital, Parkville, Victoria, Australia"
      ],
      "name": "Kathleen Byrne"
    },
    {
      "affiliations": [
        "Critical Care Program, The George Institute for Global Health, Sydney, New South Wales, Australia"
      ],
      "name": "Anthony Delaney"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Katharine J Drummond"
    },
    {
      "affiliations": [
        "Institute of Intensive Care Medicine, University Hospital Zurich, Zürich, Switzerland"
      ],
      "name": "Matthias Haenggi"
    },
    {
      "affiliations": [
        "Clinical Research Centre, University College Dublin, Dublin, Ireland"
      ],
      "name": "Leanne M Hays"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Alisa Higgins"
    },
    {
      "affiliations": [
        "Department of Anaesthesia and Critical Care, Brest University Hospital Centre, Brest, Brittany, France"
      ],
      "name": "Olivier Huet"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Martin K Hunn"
    },
    {
      "affiliations": [
        "University of Bern, Bern, Switzerland"
      ],
      "name": "Stephan M Jakob"
    },
    {
      "affiliations": [
        "Department of Surgery, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Philip M Lewis"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Kuan-Ying Lu"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Cambridge, Cambridge, UK"
      ],
      "name": "David Menon"
    },
    {
      "affiliations": [
        "Intensive Care Unit, Wellington Hospital, Wellington, New Zealand"
      ],
      "name": "James Moore"
    },
    {
      "affiliations": [
        "School of Medicine, University College Dublin, Dublin, Ireland"
      ],
      "name": "Patrick T Murray"
    },
    {
      "affiliations": [
        "Intensive Care Unit, University Hospitals Sussex NHS Foundation Trust, Worthing, UK"
      ],
      "name": "John Porter"
    },
    {
      "affiliations": [
        "Intensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia"
      ],
      "name": "Benjamin Reddi"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Jeffrey V Rosenfeld"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand"
      ],
      "name": "Jonathon D Taylor"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Anthony Trapani"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Shirley Vallance"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Charité - Universitätsmedizin Berlin, Berlin, Germany"
      ],
      "name": "Stefan Wolf"
    },
    {
      "affiliations": [
        "Department of Anaesthesia and Intensive Care, Centre Hospitalier Universitaire de Grenoble, Grenoble, France"
      ],
      "name": "Jean-Francois Payen"
    },
    {
      "affiliations": [
        "Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Bruxelles, Belgium"
      ],
      "name": "Fabio Silvio Taccone"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia",
        "Clinical Research Centre, University College Dublin, Dublin, Ireland"
      ],
      "name": "Alistair Nichol"
    },
    {
      "affiliations": [
        "Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia",
        "Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "D James Cooper"
    }
  ],
  "title": "Brain tissue oxygen monitoring for severe traumatic brain injury: the international multicentre randomised controlled BONANZA-GT study protocol",
  "uid": "d8c9e74c-fdb1-5a23-9b61-47e60f29eba9"
}