NCT02355548已完成不适用
Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE
研究概览
简要总结
This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
- •Total Pulmonary Embolism Severity Index (PESI) score <86
排除标准
- •Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram
- •Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay.
- •Renal insufficiency (Creatinine Clearance <30)
- •Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal)
- •Unreliable social situation or inability to follow up
- •Contraindication to enoxaparin, warfarin and rivaroxaban
- •Atrial or ventricular dysrhythmia(s)
结局指标
主要结局
90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE
时间窗: 90 Days
This is a composite outcome of the above.
次要结局
- Level of patient satisfaction as measured by survey.(90 Days Post study enrollment)
- Reduction of medical costs due to outpatient treatment.(90 Days)
研究者
研究点 (1)
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