Journal
BMJ OPEN
Volume 10, Issue 11, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2020-042093
Keywords
trauma management; neurological injury; biochemistry; magnetic resonance imaging
Categories
Funding
- ERA-NET Neuron Cofund part of the European Research Projects on External Insults to the Nervous System call, within the Horizon 2020 funding framework [MR/R004528/1]
- Alzheimer's Research UK Clinical Research Fellowship
- UK Dementia Research Institute (DRI) Care Research and Technology Centre (NG/DJS)
- National Institute of Health Research (NIHR) Professorship [NIHR-RP-011-048]
- NIHR Clinical Research Facility and Biomedical Research Centre (BRC) at Imperial College Healthcare NHS Trust
- Medical Research Council through a Clinician Scientist Fellowship
- MRC [UKDRI-1003, MR/R004528/1, UKDRI-7006] Funding Source: UKRI
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Introduction and aims Traumatic brain injury (TBI) often results in persistent disability, due particularly to cognitive impairments. Outcomes remain difficult to predict but appear to relate to axonal injury. Several new approaches involving fluid and neuroimaging biomarkers show promise to sensitively quantify axonal injury. By assessing these longitudinally in a large cohort, we aim both to improve our understanding of the pathophysiology of TBI, and provide better tools to predict clinical outcome. Methods and analysis BIOmarkers of AXonal injury after TBI is a prospective longitudinal study of fluid and neuroimaging biomarkers of axonal injury after moderate-to-severe TBI, currently being conducted across multiple European centres. We will provide a detailed characterisation of axonal injury after TBI, using fluid (such as plasma/microdialysate neurofilament light) and neuroimaging biomarkers (including diffusion tensor MRI), which will then be related to detailed clinical, cognitive and functional outcome measures. We aim to recruit at least 250 patients, including 40 with cerebral microdialysis performed, with serial assessments performed twice in the first 10 days after injury, subacutely at 10 days to 6 weeks, at 6 and 12 months after injury. Ethics and dissemination The relevant ethical approvals have been granted by the following ethics committees: in London, by the Camberwell St Giles Research Ethics Committee; in Policlinico (Milan), by the Comitato Etico Milano Area 2; in Niguarda (Milan), by the Comitato Etico Milano Area 3; in Careggi (Florence), by the Comitato Etico Regionale per la Sperimentazione Clinica della Regione Toscana, Sezione area vasta centro; in Trento, by the Trento Comitato Etico per le Sperimentazioni Cliniche, Azienda Provinciale per i Servizi Sanitari della Provincia autonoma di Trento; in Lausanne, by the Commission cantonale d'ethique de la recherche sur l'etre humain; in Ljubljana, by the National Medical Ethics Committee at the Ministry of Health of the Republic of Slovenia. The study findings will be disseminated to patients, healthcare professionals, academics and policy-makers including through presentation at conferences and peer-reviewed publications. Data will be shared with approved researchers to provide further insights for patient benefit.
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