A Blood Biomarker Study With Clinical Correlation for the Diagnosis and Prognosis of Sports Related Concussion in Elite Rugby
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical Diagnosis
研究概览
简要总结
The diagnosis of sports related concussion still relies heavily on a subjective assessment. In this study the investigators want to assess the prognostic value of blood-based biomarkers with recovery from concussive episodes over specific time points post-injury. Our research aims to (1) assess that the World Rugby's head injury assessment (HIA) can identify that a concussion has taken place by measuring specific biomarkers in the blood and (2) to track these biomarkers over time post-injury as a means to assess player health.
详细描述
The diagnosis and prognosis of sports related concussion (SRC) still rely on a subjective assessment based on the SCAT5 procedure. Our knowledge of how sports related concussion effects an athlete over time is limited as all patients may have different recovery times from concussion. Our research aims to quantitatively confirm that the head injury assessment has predicted a concussion against clinical assessment (SCAT5) and that a return to play protocol allows sufficient recovery time for an athlete.
Numerous novel areas of diagnosis are currently under investigation including protein-based biomarkers. In the context of SRC, these protein biomarkers typically consist of neurological proteins normally confined to the central nervous system or associated with neurological cell damage. Recent studies have compared biomarker levels at different time points post-diagnosis or investigated the relationship between early biomarker levels and return to play (RTP) times. However, the use of these biomarkers for actively evaluating player recovery following SRC has yet to be fully investigated. In this study, the investigators will measure biomarkers levels across multiple time points post-SRC to assess the value of these biomarkers to monitor player recovery. This is of significant for minimising premature RTP and, ultimately, aiming to reduce the chronic long-term effects associated with SRC.
To truly identify a biomarker specific to concussion this study will need to, first, analyse the bloods of concussion patients and compare to the clinical assessment of the head injury assessment (HIA), and, second, measure their levels over time to indicate recovery that may aid in a safe return to play.
Briefly, blood samples are taken from consented participants at the start of pre-season to act as a baseline. Once one of these participants enters the HIA process their bloods are taken post-injury, 6 days after injury and 13 days after injury. Next, the biomarkers are measured in the blood samples at each time point to examine if there is any increase/decrease in their levels.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to participate if they
- •are part of the professional rugby team's senior squad or the academy;
- •aged over 18;
- •consent to the study over the whole season.
排除标准
- •Participants are excluded if they
- •are unable to attend the preseason baseline draw;
- •unable to give informed consent.
结局指标
主要结局
Clinical Diagnosis
时间窗: Bloods to be taken within 72 hours of injury
Measure the levels of blood biomarkers in rugby players that have experienced a concussion, confirmed via HIA and neuropsychometric assessment, to assess the utility of these biomarkers for concussion diagnosis
Clinical Recovery
时间窗: Bloods to be taken within 6 and 13 days post-injury
Track the levels of the blood biomarkers over time, post-injury to determine if biomarker levels correlate with clinical recovery.
次要结局
未报告次要终点