NCT01899339已完成不适用
Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Right Ventricular:Left Ventricular ratio
研究概览
简要总结
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9
排除标准
- •age > 80
- •Recent thrombolytic therapy (with in 4 days)
- •Active bleeding or know bleeding diathesis
- •Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50
- •Thrombocytopenia (PLT cound < 100,000)
- •History of any intracranial or intraspinal surgery, trauma or bleed
- •Intracranial neoplasms, AVM, or aneurysm
- •Recent (< 1 month) GI bleed
- •Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy
- •Recent (< 7 days) major surgery, trauma, or obstetrical delivery
- •Renal insufficiency with eGFR < 45 ml/min
- •Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
- •Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP >
- •Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.
- •Pregnant patients
- •known right to left shunt
- •Large (>10 mm)intracardiac thrombus
- •Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
- •Life expectancy < 30 days
结局指标
主要结局
Change in Right Ventricular:Left Ventricular ratio
时间窗: baseline to 72 hours post
Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.
次要结局
- recurrent pulmonary embolism(30 days post procedure)
研究者
Michael F Knox, MD
Medical Doctor
Spectrum Health Hospitals
研究点 (1)
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