NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Neurotrauma and Ophthalmology Research Group, Institute of Inflammation and Aging, University of Birmingham, Birmingham, UK.
BMJ Open. 2018 Nov 25;8(11):e024245. doi: 10.1136/bmjopen-2018-024245.
The diagnosis of mild traumatic brain injury or sports-related concussion is a challenge for all clinicians, players, coaches and parents involved in contact sports. Currently, there is no validated objective biomarker available to assess the presence or severity of concussion in sport, and so it is necessary to rely on subjective measures like self-reporting of symptoms which depend on the cooperation of the athlete. There is a significant health risk associated with repetitive injury if the diagnosis is missed, and so there is great value in an objective biomarker to assist diagnostic and prognostic decisions.
To establish a panel of non-invasive MicroRNA biomarkers in urine and saliva for the rapid diagnosis of sports-related concussion and investigate the kinetics and clinical utility of these biomarkers in assisting diagnostic, prognostic and return-to-play decisions.
Observational, prospective, multicentre cohort study recruiting between the 2017-2018 and 2018-2019 Rugby Union seasons. Professional rugby players in the two highest tiers of senior professional domestic rugby competition in England will be recruited prospectively to the study. During the season, three groups will be identified: athletes entering the World Rugby Head Injury Assessment (HIA) protocol, uninjured control athletes and control athletes with musculoskeletal injuries. Saliva and urine will be collected from these athletes at multiple timepoints, coinciding with key times in the HIA protocol and return-to-play process.
Ethics approval has been obtained. The compiled and analysed results will be presented at national and international conferences concerning the care of patients with traumatic brain injury. Results will also be submitted for peer review and publication in the subject journals/literature.
对于参与接触性运动的所有临床医生、运动员、教练和家长来说，轻度创伤性脑损伤或与运动相关的脑震荡的诊断都是一项挑战。目前，尚无经过验证的客观生物标志物可用于评估运动中脑震荡的存在或严重程度，因此有必要依赖于主观指标，如运动员的自我报告症状，这取决于运动员的配合。如果诊断被遗漏，与重复受伤相关的健康风险是巨大的，因此需要客观的生物标志物来协助诊断和预后决策。
建立尿液和唾液中无创性 MicroRNA 生物标志物的检测方法，用于快速诊断与运动相关的脑震荡，并研究这些生物标志物在协助诊断、预后和重返赛场决策中的动力学和临床应用价值。
这是一项观察性、前瞻性、多中心队列研究，在 2017-2018 年和 2018-2019 年橄榄球联盟赛季期间进行。将前瞻性地招募英格兰国内最高两个高级职业橄榄球联赛的职业橄榄球运动员参与这项研究。在赛季期间，将确定三组运动员：进入世界橄榄球头部损伤评估（HIA）协议的运动员、未受伤的对照组运动员和有肌肉骨骼损伤的对照组运动员。将在多个时间点从这些运动员中采集唾液和尿液，与 HIA 协议和重返赛场过程中的关键时间点重合。
已获得伦理批准。编译和分析的结果将在涉及创伤性脑损伤患者护理的国家和国际会议上展示。结果还将提交同行评审，并在相关期刊/文献中发表。
