NCT01007045已完成不适用
Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
研究概览
简要总结
Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.
The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.
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
- •Clinically suspected lower extremity DVT
排除标准
- •Known chronic DVT
- •Acute DVT confirmed by prior formal imaging
- •Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
- •Anticoagulation >48 hours prior to imaging (formal or LCU)
结局指标
主要结局
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
时间窗: 3 days
Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.
时间窗: 3 days
次要结局
- interobserver reliability of modified Well's criteria(3 days)
- learning curve for LC U/S by emergency physicians and residents(365 days)
- difference in diagnostic time interval for patients grouped by pre-test probability(3 days)
- number of return visits for formal ultrasound imaging(3 days)
- number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending(3 days)
研究者
研究点 (2)
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