Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 11
- 主要终点
- Clinically important traumatic brain injury
研究概览
简要总结
The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications.
The objectives are to:
- Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and,
- Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.
详细描述
This is a prospective cohort study enrolling 4000 anticoagulated patients presenting with blunt head trauma to the emergency department. Emergency physicians will record the presence or absence of clinical predictors for traumatic brain injury at the time of assessment. All patients will undergo head CT scanning and are followed for 30 days.
The adjudicated primary outcome is clinically important traumatic brain injury diagnosed at the index ED presentation. The secondary outcome is delayed clinically important traumatic brain injury, diagnosed within 30 days of normal index head CT scan.
The primary analysis will be to derive a novel clinical decision rule which excludes clinically important traumatic brain injury diagnosed at the index ED visit. The secondary analyses will include:
- The diagnostic accuracy of existing head injury clinical decision rules in diagnosing clinically important traumatic brain injury on index ED visit, in patients who take anticoagulation; and,
- The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.
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
- 否
入选标准
- •Age ≥16 years
- •Presents to the emergency department after a head injury
- •Patient has a head CT in the emergency department
- •Is a current anticoagulant user
排除标准
- •Head injury occurred >48 h before patient's arrival to the emergency department
- •Penetrating head injury
- •Previously enrolled
- •Patient resides outside of the hospital's catchment area
- •Patient was transferred from another emergency department following neuroimaging
- •Patient was not managed by the emergency or trauma physician in the emergency department
- •Leaves the emergency department prior to completion of their medical assessment
结局指标
主要结局
Clinically important traumatic brain injury
时间窗: Index emergency department presentation
Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis.
次要结局
- Delayed clinically important traumatic brain injury(Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation)
研究者
Dr. Kerstin de Wit
Associate Professor
Queen's University