Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,727
- 试验地点
- 9
- 主要终点
- objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated
研究概览
简要总结
The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis.
详细描述
- Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of < 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of < 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than:
- Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of < 0.5 µg FEU/mL to exclude thrombosis (current practice).
All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18 and older
- •Presenting with symptoms compatible with clinically suspected deep vein thrombosis
排除标准
- •Treatment with full dose anticoagulation for 24 hours or more.
- •Other test for deep vein thrombosis already performed.
- •Ongoing need for therapeutic anticoagulant therapy.
- •Life expectancy less than 3 months.
- •Absence of acute symptoms within 7 days of presentation.
- •Presenting with symptoms of pulmonary embolism.
- •Previous confirmed episode of deep vein thrombosis or pulmonary embolism.
- •Current pregnancy.
- •Geographic inaccessibility which precludes follow-up.
研究组 & 干预措施
1
Selective D-Dimer use
干预措施: D-dimer testing (Procedure)
2
Uniform D-Dimer use
干预措施: D-dimer testing (Procedure)
结局指标
主要结局
objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated
时间窗: 3 Months
次要结局
- bleeding(3 Months)
- healthcare utilization(3 Months)
- cost-effectiveness(3 Months)