NCT00182546终止3 期
Canadian Pulmonary Embolism Diagnosis Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,126
- 试验地点
- 14
- 主要终点
- DVT or PE during 6 months follow-up
研究概览
简要总结
The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.
It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test
详细描述
To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with clinically suspected PE
排除标准
- •Treatment with anticoagulants for greater than 24 hours of performance of D-d
- •Comorbid condition limiting survival to less than 3 months
- •Absence of acute symptoms within 7 days prior to presentation
- •Current pregnancy
- •Contraindication to contrast (e.g., allergy, renal failure)
- •Geographic inaccessibility which precludes follow-up
- •Physician believes patient is inappropriate for study
- •failure or inability to provide informed consent
结局指标
主要结局
DVT or PE during 6 months follow-up
次要结局
- bleeding
研究者
研究点 (14)
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