NCT00182221已完成3 期
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Venousthromboembolism
研究概览
简要总结
To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE.
To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.
详细描述
Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-Dimer undergo standardized testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 years or older
- •Suspected PE
排除标准
- •Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants
- •Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram).
- •Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result)
- •Comorbid condition limiting survival to less than three months
- •Patient has been asymptomatic for seven days prior to presentation
- •Current pregnancy
- •Contraindication to contrast (e.g., allergy, renal failure).
- •Geographic in accessibility which precludes follow-up
- •Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility assessment
结局指标
主要结局
Venousthromboembolism
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (4)
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