D-dimer Testing, Tailored to Clinical Pretest Probability, to Minimize Initial and Follow-up Ultrasound Imaging in Suspected Deep Vein Thrombosis: A Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,513
- 试验地点
- 10
- 主要终点
- Confirmed symptomatic proximal Deep Vein Thrombosis
研究概览
简要总结
This is a cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test.
详细描述
This is a prospective, multicentre, cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients. The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test. Less ultrasound testing will be performed because: i) more patients will have deep vein thrombosis excluded by combinations of Clinical Pretest Probability and D-dimer results on the day of presentation; and, ii) in those who still need an ultrasound, a repeat ultrasound a week after a normal result will only be performed if the D-dimer result is markedly abnormal at initial presentation. The safety of this management strategy will be established by demonstrating a very low rate of proximal Deep Vein Thrombosis or Pulmonary Embolism during 90 days follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. Diagnostic test utilization will be assessed. All clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial D-dimer measurements and patient management.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.
排除标准
- •Age less than 18 years.
- •Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
- •D-dimer level known before Clinical Pretest Probability documented.
- •Ultrasound of the leg performed before Clinical Pretest Probability was documented
- •Ultrasound was or will be performed in a patient with low Clinical Pretest Probability and a d-dimer <1000(or equivalent), or with Moderate Clinical Pretest Probability and a D-dimer <500 (or equivalent) (e.g. suspected bleeding).
- •Ongoing need for anticoagulant therapy.
- •Suspected Pulmonary Embolism.
- •Superficial venous thrombosis that requires, or may require, anticoagulant therapy.
- •Life expectancy less than 3 months.
- •Previously confirmed episode of Deep Vein Thrombosis.
- •Geographic inaccessibility which precludes follow-up.
- •Known pregnancy.
结局指标
主要结局
Confirmed symptomatic proximal Deep Vein Thrombosis
时间窗: within 90 days
The primary outcome is confirmed symptomatic proximal Deep Vein Thrombosis (including involvement of the calf vein trifurcation but not isolated more distal Deep Vein Thrombosis; or pulmonary embolism (not including isolated sub-segmental abnormalities on Computed Tomography Pulmonary Angiogram; within 90 days (± 7 days for follow-up assessment) that is not diagnosed by scheduled diagnostic testing (includes events that occur between initial and scheduled follow-up proximal ultrasound examinations).
次要结局
- Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups(within 90 days)
- Death(within 90 days)