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临床试验/NCT07129577
NCT07129577尚未招募不适用

Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 400 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
Understanding of the current clinical pathway and how use of point of care biomarkers may change this.

研究概览

简要总结

Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as mild TBI (mTBI), also referred to as concussion. In the acute setting, mTBI is typically defined by a Glasgow Coma Scale (GCS) score of 13-15 on presentation.

Current acute management focuses primarily on identifying which patients require a CT head scan to detect life threatening injuries that may need neurosurgical intervention, observation, or neurocritical care. However, there is increasing recognition that the term "mild" can be misleading. Many patients, including those with normal CT scans,experience persistent functional, cognitive, and symptomatic deficits that may benefit from further intervention and follow-up care.

Blood biomarkers offer significant potential to improve the early diagnosis, risk stratification, and prognostication of mTBI in the ED setting. While these biomarkers are increasingly being developed and evaluated in moderate and severe TBI, their clinical utility in mild TBI has not yet been definitively demonstrated.

To fully assess their potential value, it is essential to understand the current care pathways for mTBI in the ED, how they are implemented in practice, and where biomarker information could meaningfully enhance clinical decision making and improve patient outcomes.

The POCKET study will use a systems engineering approach, in combination with health economic evaluation, to assess the potential role and utility of point-of-care blood biomarkers in the management of mild TBI in UK emergency departments. This research will be conducted using the Abbott biomarker platform.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥ 18 years of age)
  • Glasgow Coma Score >12
  • Presentation within 24 hours of head injury
  • Meet criteria to be assessed using NICE NG232 clinical decision support tool (CDST).
  • Patients with a prior history of TBI may still be included.

排除标准

  • Participant without capacity and no available patient legal representative or professional consultee.
  • Participant with capacity unwilling to provide informed consent
  • Unable to adequately understand written and verbal English.
  • Prisoners currently in custody of HM Prison Service

结局指标

主要结局

Understanding of the current clinical pathway and how use of point of care biomarkers may change this.

时间窗: From enrolment to 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Virginia Newcombe

Honorary Consultant in Critical Care and Emergency Medicine / Clinician Scientist Fellow

Cambridge University Hospitals NHS Foundation Trust

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