Submassive Pulmonary Embolism Experience With EKOS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction of RV dysfunction
研究概览
简要总结
This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE
详细描述
Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.
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
- •Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
- •RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo
- •Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
- •PE symptom duration < 21 days
- •Age >18 years
- •And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat < 90% RA, or inability to maintain a HR <100, or inability to maintain a Systolic Bp >
- •Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100)..
排除标准
- •Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- •Recent (within one month) or active bleeding from a major organ
- •Hemoglobin (Hgb) < 8.0
- •Platelets < 60 thousand/µL
- •Major surgery within seven days
- •Clinician deems high-risk for catastrophic bleeding
- •History of heparin-induced thrombocytopenia (HIT)
- •Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
- •Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
- •Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
- •Evidence of irreversible neurological compromise
- •Life expectancy < 30 days
- •Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
结局指标
主要结局
Reduction of RV dysfunction
时间窗: 48 hours post catheter removal
Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal
次要结局
未报告次要终点
研究者
Krishna Mannava, MD, FACS, RPVI
Krishna Mannava, MD, FACS, RPVI
Fairfield Medical Center