PREdiction and Diagnosis using Imaging and Clinical biomarkers Trial in Traumatic Brain Injury (PREDICT-TBI) study protocol: an observational, prospective, multicentre cohort study for the prediction of outcome in moderate-to-severe TBI
Siva Senthuran,
Lewis Campbell,
Jennifer Fleming,
Virginia Newcombe,
Michael Reade,
Silvia Manzanero,
James Walsham,
Nathan Brown,
Xuan Vinh To,
Clifford Pollard,
Fatima Nasrallah,
Judith Bellapart,
Esther Jacobson,
Jason Meyer,
Janine Stuart,
Tracey Evans,
Shekhar S Chandra,
Jason Ross,
James McCullough
Affiliations
Siva Senthuran
Intensive Care Unit, Townsville Hospital and Health Service, Townsville, Queensland, Australia
Lewis Campbell
Intensive Care Unit, Royal Darwin Hospital, Casuarina, Darwin, Australia
Jennifer Fleming
School of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia
Virginia Newcombe
Emergency and Urgent Care Research in Cambridge (EURECA), PACE Section, Department of Medicine, University of Cambridge, Cambridge, UK
Michael Reade
Faculty of Medicine, Medical School, University of Queensland, Brisbane, Queensland, Australia
Silvia Manzanero
Jamieson Trauma Institute, Royal Brisbane & Womens Hospital (RBWH), Metro North Health, Brisbane, Queensland, Australia
James Walsham
Intensive Care Unit, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Nathan Brown
Department of Anesthesia, Perioperative and Pain Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
Xuan Vinh To
The Queensland Brain Institute, The University of Queensland, Saint Lucia, Queensland, Australia
Clifford Pollard
Jamieson Trauma Institute, Royal Brisbane & Womens Hospital (RBWH), Metro North Health, Brisbane, Queensland, Australia
Fatima Nasrallah
The Queensland Brain Institute, The University of Queensland, Saint Lucia, Queensland, Australia
Judith Bellapart
Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
Esther Jacobson
Jamieson Trauma Institute, Metro North Health Service District, Herston, Queensland, Australia
Jason Meyer
Intensive Care Unit, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Janine Stuart
Intensive Care Unit, Royal Brisbane and Women’s Hospital, Metro North Health Service District, Herston, Queensland, Australia
Tracey Evans
The Queensland Brain Institute, The University of Queensland, Saint Lucia, Queensland, Australia
Shekhar S Chandra
School of Information Technology and Electrical Engineering, Architecture and Information Technology, The University of Queensland, Saint Lucia, Queensland, Australia
Jason Ross
Health and Biosecurity, CSIRO, Westmead, New South Wales, Australia
James McCullough
Intensive Care Unit, Gold Coast Hospital and Health Service, Gold Coast, Queensland, Australia
Introduction Traumatic brain injury (TBI) is a heterogeneous condition with a broad spectrum of injury severity, pathophysiological processes and variable outcomes. For moderate-to-severe TBI survivors, recovery is often protracted and outcomes can range from total dependence to full recovery. Despite advances in medical treatment options, prognosis remains largely unchanged. The objective of this study is to develop a machine learning predictive model for neurological outcomes at 6 months in patients with a moderate-to-severe TBI, incorporating longitudinal clinical, multimodal neuroimaging and blood biomarker predictor variables.Methods and analysis A prospective, observational, cohort study will enrol 300 patients with moderate-to-severe TBI from seven Australian hospitals over 3 years. Candidate predictors including demographic and general health variables, and longitudinal clinical, neuroimaging (CT and MRI), blood biomarker and patient-reported outcome measures will be collected at multiple time points within the acute phase of injury. The predictor variables will populate novel machine learning models to predict the Glasgow Outcome Scale Extended 6 months after injury. The study will also expand on current prognostic models by including novel blood biomarkers (circulating cell-free DNA), and the results of quantitative neuroimaging such as Quantitative Susceptibility Mapping and Dynamic Contrast Enhanced MRI as predictor variables.Ethics and dissemination Ethical approval has been obtained by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee, Queensland. Participants or their substitute decision-maker/s will receive oral and written information about the study before providing written informed consent. Study findings will be disseminated by peer-review publications and presented at national and international conferences and clinical networks.Trial registration number ACTRN12620001360909.
