The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,556
- 主要终点
- Rate of head injury complication in study cohort
研究概览
简要总结
Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. The investigators aimed to undertake research in order to understand the range and frequency of outcomes following head injury in this group of patients and to develop robust clinical guidance for how they should be optimally managed in the future.
详细描述
This prospective observational study aims to enrol patients taking warfarin that attend participating ED's (up to 33) in England and Scotland after blunt head injury. Over an 18-month period from Oct 2011, ED attendance data will be collected from each ED as well as information from patient questionnaires about the care the patient received and the status of their health 6-10 weeks after the injury. Patients who died due to their head injury, experienced surgery due to their injury, had a change identified on a CT scan or re-attended the ED with a clear head injury complication are defined as experiencing a poor outcome. Information such as the patients' conscious state (GCS), level of clotting in their blood (INR) and symptoms will be investigated as predictors of a poor outcome. A mathematical model will be used to estimate the most cost-effective strategy assuming published National Institute for Health and Care Excellence (NICE) thresholds for cost per quality adjusted life year (QALY).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16 years or older
- •Blunt head trauma above the neck within 24 hours of ED attendance
- •Prescribed warfarin
排除标准
- •Penetrating injuries to the head, for example knife wound.
结局指标
主要结局
Rate of head injury complication in study cohort
时间窗: 18 months
Head injury complications defined as death or neurosurgery resulting from the initial injury, a clinically-significant CT scan finding or re-attendance to the ED with a significant head injury-related complication up to 10 weeks after the original attendance.
次要结局
- Prevalence of ongoing symptoms relating to the head injury(18 months)
- Identification of early predictors of adverse clinical outcome(18 months)
研究者
Professor Suzanne Mason
Professor of Emergency Medicine
University of Sheffield