Dataset Information

Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.

ABSTRACT: 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.

SUBMITTER: Graham NSN

PROVIDER: S-EPMC7656955 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.

Graham Neil Samuel Nyholm NSN Zimmerman Karl A KA Bertolini Guido G Magnoni Sandra S Oddo Mauro M Zetterberg Henrik H Moro Federico F Novelli Deborah D Heslegrave Amanda A Chieregato Arturo A Fainardi Enrico E Fleming Joanne M JM Garbero Elena E Abed-Maillard Samia S Gradisek Primoz P Bernini Adriano A Sharp David J DJ

BMJ open 20201110 11

<h4>Introduction and aims</h4>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 cl ...[more]

PMID: 33172948

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Project description:ObjectiveSevere traumatic brain injury is a significant cause of morbidity and mortality in young adults. Assessing long-term neurological outcome after such injury is difficult and often characterised by uncertainty. The objective of this feasibility study was to establish the feasibility of conducting a large, multicentre prospective study to develop a prognostic model of long-term neurological outcome in critically ill patients with severe traumatic brain injury.DesignA prospective cohort study.Setting9 Canadian intensive care units enrolled patients suffering from acute severe traumatic brain injury. Clinical, biological, radiological and electrophysiological data were systematically collected during the first week in the intensive care unit. Mortality and functional outcome (Glasgow Outcome Scale extended) were assessed on hospital discharge, and then 3, 6 and 12?months following injury.OutcomesThe compliance to protocolised test procedures was the primary outcome. Secondary outcomes were enrolment rate and compliance to follow-up.ResultsWe successfully enrolled 50 patients over a 12-month period. Most patients were male (80%), with a median age of 45?years (IQR 29.0-60.0), a median Injury Severity Score of 38 (IQR 25-50) and a Glasgow Coma Scale of 6 (IQR 3-7). Mortality was 38% (19/50) and most deaths occurred following a decision to withdraw life-sustaining therapies (18/19). The main reasons for non-enrolment were the time window for inclusion being after regular working hours (35%, n=23) and oversight (24%, n=16). Compliance with protocolised test procedures ranged from 92% to 100% and enrolment rate was 43%. No patients were lost to follow-up at 6?months and 2 were at 12?months.ConclusionsIn this multicentre prospective feasibility study, we achieved feasibility objectives pertaining to compliance to test, enrolment and follow-up. We conclude that the TBI-Prognosis prospective multicentre study in severe traumatic brain injury patients in Canada is feasible.

Project description:Background: Low and medium income countries (LMICs) such as Kenya experience nearly three times more cases of traumatic brain injury (TBI) compared to high income countries (HICs). This is primarily exacerbated by weak health systems especially at the pre-hospital care level. Generating local empirical evidence on TBI patterns and its influence on patient mortality outcomes is fundamental in informing the design of trauma-specific emergency medical service (EMS) interventions at the pre-hospital care level. This study determines the influence of TBI patterns and mortality. Methods: This was a case-control study with a sample of 316 TBI patients. Data was abstracted from medical records for the period of January 2017 to March 2019 in three tertiary trauma care facilities in Kenya. Logistic regression was used to assess influence of trauma patterns on TBI mortality, controlling for patient characteristics and other potential confounders. Results: The majority of patients were aged below 40 years (73%) and were male (85%). Road traffic injuries (RTIs) comprised 58% of all forms of trauma. Blunt trauma comprised 71% of the injuries. Trauma mechanism was the only trauma pattern significantly associated with TBI mortality. The risk of dying for patients sustaining RTIs was 2.83 times more likely compared to non-RTI patients [odds ratio (OR) 2.83, 95% confidence interval (CI) 1.62-4.93, p=0.001]. The type of transfer to hospital was also significantly associated with mortality outcome, with a public hospital having a two times higher risk of death compared to a private hospital [OR 2.18 95%CI 1.21-3.94, p<0.009]. Conclusion: Trauma mechanism (RTI vs non-RTI) and type of tertiary facility patients are transferred to (public vs private) are key factors influencing TBI mortality burden. Strengthening local EMS trauma response systems targeting RTIs augmented by adequately resourced and equipped public facilities to provide quality lifesaving interventions can reduce the burden of TBIs.

Dataset Information

Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.

Publications

Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.

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