NCT00182247终止3 期
D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 600
- 试验地点
- 15
- 主要终点
- symptomatic DVT and PE in follow-up
研究概览
简要总结
To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.
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
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected deep vein thrombosis
- •history of previous DVT or PE
排除标准
- •comorbid condition limiting survival to less than 6 months
- •contraindication to contrast medium (allergy, renal dysfunction, creatinine > 150mcmol/L)
- •receiving long-term warfarin or heparin therapy
- •received full-dose heparin therapy for more than 48 hours
- •pregnancy
- •symptomatic for pulmonary embolism
- •absence of symptoms within 5 days of presentation
- •geographic inaccessibility which precludes follow-up
结局指标
主要结局
symptomatic DVT and PE in follow-up
次要结局
- death
- deep vein thrombosis diagnosed by venography in those
- randomized to that intervention
研究者
研究点 (15)
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