Assessing the Safety and Efficiency of a Simplified Diagnostic Approach for Deep Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- False negative rate of the new DVT testing
研究概览
简要总结
This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death.
The main questions the study aims to answer are:
- How safe is our new blood clot testing method?
- How efficient is our new blood clot testing method?
The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •emergency physician decides to test for DVT of the lower limb.
排除标准
- •<18 years of age;
- •tested for DVT without using the ToDay algorithm at the index visit;
- •D-dimer level is known before ToDay item assessment;
- •a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant;
- •a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging;
- •suspected of having a pulmonary embolism;
- •has previously participated in this study;
- •has previously opted out of all research at hospital site;
- •left the emergency department or urgent care centre against medical advice;
- •D-dimer was ordered prior to initial physician assessment;
- •imaging for DVT or pulmonary embolism within the previous 30 days;
- •transferred from another hospital organization.
结局指标
主要结局
False negative rate of the new DVT testing
时间窗: This will be measured at 30-days after the patient's index emergency department visit.
This is the proportion of patients who have DVT excluded by the new ToDay protocol and who were subsequently diagnosed with either a lower limb DVT or pulmonary embolism.
次要结局
- Efficiency of the new DVT testing(At the index emergency department visit.)
研究者
Dr. Kerstin de Wit
Associate Professor Department of Emergency Medicine
Queen's University