Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.
Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol.
复制标题
DOI：
10.1136/bmjopen-2020-042093
复制
发表时间：
2020-11-10
期刊：
影响因子：
2.9
通讯作者：
Sharp DJ
中科院分区：
文献类型：
--
作者：
Graham NSN;Zimmerman KA;Bertolini G;Magnoni S;Oddo M;Zetterberg H;Moro F;Novelli D;Heslegrave A;Chieregato A;Fainardi E;Fleming JM;Garbero E;Abed-Maillard S;Gradisek P;Bernini A;Sharp DJ
创伤性脑损伤（TBI）通常会导致持续性残疾，特别是由于认知障碍。结果仍然难以预测，但似乎与轴索损伤有关。几种涉及液体和神经成像生物标志物的新方法有望敏感地量化轴索损伤。通过在一个大队列中纵向评估这些，我们的目的是提高我们对TBI病理生理学的理解，并提供更好的工具来预测临床结果。脑外伤后轴突损伤的生物标志物是一项关于中重度脑外伤后轴突损伤的液体和神经成像生物标志物的前瞻性纵向研究，目前正在多个欧洲中心进行。我们将提供TBI后轴突损伤的详细特征，使用液体（如血浆/微透析神经丝光）和神经成像生物标志物（包括弥散张量MRI），然后将与详细的临床，认知和功能结果测量相关。我们的目标是招募至少250名患者，其中包括40名进行了脑微透析的患者，在受伤后的前10天、10天至6周、6个月和12个月进行了两次亚急性评估。相关的伦理批准已由以下伦理委员会批准：在伦敦，由坎伯韦尔圣吉尔斯研究伦理委员会；在Policlinico（米兰），由Comitato Etico Milano第2区负责；在尼瓜尔达（米兰），由米兰委员会第三区负责；在Careggi（佛罗伦萨），由托斯卡纳地区临床实验地区委员会负责，塞齐奥内地区中心；在特伦托，由特伦托临床实验委员会、特伦托省卫生服务委员会和特伦托省自治委员会负责；在洛桑，由委员会主持，并由être人类研究组织主持；在卢布尔雅那，由斯洛文尼亚共和国卫生部国家医学伦理委员会负责。研究结果将通过在会议上的介绍和同行评审的出版物向患者、医疗保健专业人员、学者和政策制定者传播。数据将与获得批准的研究人员共享，为患者的利益提供进一步的见解。NCT03534154。
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. 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. 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. NCT03534154.
登录
查看更多内容
影响因子：
14.5
作者：
Magnoni, Sandra;Mac Donald, Christine L.;Brody, David L.
通讯作者：
Brody, David L.
DOI：
10.1073/pnas.1000175107
发表时间：
2010-03-30
影响因子：
11.1
作者：
Sharp, D. J.;Bonnelle, V.;Mehta, M. A.
通讯作者：
Mehta, M. A.
影响因子：
38.9
作者：
Bouzat, Pierre;Sala, Nathalie;Oddo, Mauro
通讯作者：
Oddo, Mauro
影响因子：
4.2
作者：
Bernick, Charles;Zetterberg, Henrik;Blennow, Kaj
通讯作者：
Blennow, Kaj
影响因子：
4.2
作者：
Hossain, Iftakher;Mohammadian, Mehrbod;Posti, Jussi P.
通讯作者：
Posti, Jussi P.