Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol
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 sensiti...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e042093.full |
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| author | Henrik Zetterberg Mauro Oddo David J Sharp Amanda Heslegrave Enrico Fainardi Neil Samuel Nyholm Graham Karl A Zimmerman Guido Bertolini Sandra Magnoni Federico Moro Deborah Novelli Arturo Chieregato Joanne M Fleming Elena Garbero Samia Abed-Maillard Primoz Gradisek Adriano Bernini |
| author_facet | Henrik Zetterberg Mauro Oddo David J Sharp Amanda Heslegrave Enrico Fainardi Neil Samuel Nyholm Graham Karl A Zimmerman Guido Bertolini Sandra Magnoni Federico Moro Deborah Novelli Arturo Chieregato Joanne M Fleming Elena Garbero Samia Abed-Maillard Primoz Gradisek Adriano Bernini |
| author_sort | Henrik Zetterberg |
| collection | DOAJ |
| description | 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’éthique de la recherche sur l’être 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.Trial registration number NCT03534154. |
| format | Article |
| id | doaj-art-f192b84da1f644bd839ad7da27be5faa |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f192b84da1f644bd839ad7da27be5faa2024-11-26T22:10:14ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-042093Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocolHenrik Zetterberg0Mauro Oddo1David J Sharp2Amanda Heslegrave3Enrico Fainardi4Neil Samuel Nyholm Graham5Karl A Zimmerman6Guido Bertolini7Sandra Magnoni8Federico Moro9Deborah Novelli10Arturo Chieregato11Joanne M Fleming12Elena Garbero13Samia Abed-Maillard14Primoz Gradisek15Adriano Bernini16Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, SwedenDepartment of Intensive Care Medicine, CHUV, Lausanne, SwitzerlandDepartment of Brain Sciences, Imperial College London, London, UKInstitute of Neurology, UCL Queen Square, London, UKDepartment of Experimental and Clinical Sciences, Careggi University Hospital, University of Firenze, Florence, ItalyDepartment of Brain Sciences, Imperial College London, London, UK1 Centre for Care, Research and Technology, UK Dementia Research Institute, Imperial College London, London, UKLaboratory of Clinical Epidemiology, Department of Medical Epidemiology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica (BG), ItalyDepartment of Anesthesia and Intensive Care, Santa Chiara Hospital, Trento, ItalyMario Negri Institute for Pharmacological Research, Milan, ItalyCardiovascular Medicine, Mario Negri Institute for Pharmacological Research, Milan, ItalyNeurorianimazione, ASST Grande Ospedale Metropolitano Niguarda, Milano, ItalyPublic Health, IRCCS-‘Mario Negri’ Institute for Pharmacological Research, Ranica, ItalyIstituto Di Ricerche Farmacologiche Mario Negri, Ranica, ItalyDepartment of Intensive Care Medicine, CHUV Lausanne University Hospital, Lausanne, SwitzerlandClinical Dpt of Anaesthesiology and Intensive Therapy, University Medical Center, Ljubljana, SloveniaDepartment of Intensive Care Medicine, CHUV Lausanne University Hospital, Lausanne, SwitzerlandIntroduction 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’éthique de la recherche sur l’être 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.Trial registration number NCT03534154.https://bmjopen.bmj.com/content/10/11/e042093.full |
| spellingShingle | Henrik Zetterberg Mauro Oddo David J Sharp Amanda Heslegrave Enrico Fainardi Neil Samuel Nyholm Graham Karl A Zimmerman Guido Bertolini Sandra Magnoni Federico Moro Deborah Novelli Arturo Chieregato Joanne M Fleming Elena Garbero Samia Abed-Maillard Primoz Gradisek Adriano Bernini Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol BMJ Open |
| title | Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol |
| title_full | Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol |
| title_fullStr | Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol |
| title_full_unstemmed | Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol |
| title_short | Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol |
| title_sort | multicentre longitudinal study of fluid and neuroimaging biomarkers of axonal injury after traumatic brain injury the bio ax tbi study protocol |
| url | https://bmjopen.bmj.com/content/10/11/e042093.full |
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