NCT00157599已完成不适用
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Suspected DVT during follow-up
研究概览
简要总结
To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 or older
- •Currently suspected for recurrent DVT
- •Has a prior history of objectively documented DVT or PE
排除标准
- •Comorbid condition limiting survival to less than 3 months
- •History of hypersensitivity to contrast medium
- •Renal dysfunction with a creatinine of > 150 mcmol/L
- •Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
- •Pregnancy or lactation
- •Symptomatic for pulmonary embolism
- •Absence of symptoms within five days prior to presentation
- •Participation in another trial precluding the use of the diagnostic algorithm in this study
- •Geographically inaccessible for follow-up
- •Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment
结局指标
主要结局
Suspected DVT during follow-up
Suspected PE during follow-up
次要结局
未报告次要终点
研究者
研究点 (11)
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