USAT-CDT Trial: Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Percentage of Thrombus Obstruction
研究概览
简要总结
The study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior to standard CDT, the former being much more expensive and more commonly used.
The purpose of the study is to learn about which catheter-directed therapy is more suitable for patients with pulmonary embolism (PE), who are candidates for both standard catheter directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to provide information regarding the cost effectiveness of the two different types of treatment. A total of 80 patients are planned to be recruited. All medication administration, procedures or in-hospital tests will be performed as routine clinical practice. The study will compare short term and long term outcomes: resolution of blood clots on CT scan, right ventricular size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.
详细描述
Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a higher mortality risk. Catheter-directed therapies, mainly standard catheter-directed thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as new, more effective, and safer treatment modalities. USAT is a modification of standard catheter thrombolysis, utilizing a system of local ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytics. However, there is limited data comparing the two treatments. More rapid clearance of pulmonary thrombus by USAT compared to standard CDT may prove to be more effective regarding clinical outcomes and cost (e.g. via reduced length of ICU and hospital stay). Alternatively, if thrombus clearance is similar, the cost of USAT may exceed the cost of CDT (equipment and disposables), without offering any potential advantage.
This controlled, randomized study seeks to determine if ultrasound acceleration adds any benefits in the outcomes and costs of catheter-directed thrombolysis for patients with acute submassive PE. The treatment with CDT or USAT are standard of care for submassive PE and participants will be randomized to receive one treatment or the other. Participants will have follow up visits at 3 months and 12 months post procedure. All the procedures, tests, and follow up visits are according to current standard of care.
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
- Single (Outcomes Assessor)
盲法说明
Pre- and post-treatment computed tomography angiography (CTA) will be compared by independent radiologists who are blinded to the type treatment received.
Pre- and post-treatment echocardiograms will be interpreted by independent cardiologists who are blinded to the type of treatment received.
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
- •Patients eligible for catheter directed thrombolysis per the study protocol for submassive pulmonary embolism (PE)
- •CT or echocardiographic RV strain (defined as RV/LV ratio >1)
- •without persisting hypotension <90mmHg or drop of systolic blood pressure by at least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion)
- •without the need of catecholamine support
- •without the need of cardiopulmonary resuscitation
排除标准
- •Pregnancy
- •Index PE symptom duration >14 days
- •High bleeding risk (any prior intracranial hemorrhage, known structural intracranial cerebrovascular disease or neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent spinal or cranial/brain surgery, recent closed-head or facial trauma with bony fracture or brain injury)
- •Participation in any other investigational drug or device study
- •Life expectancy <90 days
- •Inability to comply with study assessments
结局指标
主要结局
Percentage of Thrombus Obstruction
时间窗: Baseline to end of lysis treatment (up to 72 hours)
Computed tomography angiography (CTA) will be performed before and after treatment. An independent radiologist will quantify the degree of obstruction from the thrombus by determining the vascular obstruction index. For determining the CT obstruction index, the arterial tree of each lung will be considered to have 10 segmental arteries (three to the upper lobes, two to both the middle lobe and the lingula, and five to the lower lobes).
次要结局
- Change in Right Ventricular Systolic Pressure (RVSP)(Baseline, end of lysis treatment, Month 3, Month 12)
- Clinical Success of Treatment(Until 90 days post procedure)
- Change in Quality of Life After Pulmonary Embolism (PEmb QoL) Score(Month 3, Month 12)
- In Hospital Mortality(Until hospital discharge (an average of 6 days))
- Major Bleeding(Through follow up (12 months))
- Number of Participants Who Had a Decrease in New York Heart Association (NYHA) Functional Classification of Heart Failure From Class 4 to Class 2(Month 3, Month 12)
- Change in 36-Item, Short Form (SF-36) Score(Month 3, Month 12)
- 90-day Mortality(Until 90 days post procedure)
- Minor Bleeding(Through follow up (12 months))
- Symptomatic Venous Thromboembolism (VTE)(Until 90 days post procedure)
- Change in Right Ventricular/Left Ventricular (RV/LV) Diameter Ratio(Baseline, end of lysis treatment, Month 3, Month 12)
- Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)(Baseline, end of lysis treatment, Month 3, Month 12)
- Cardiac Decompensation Due to Massive Pulmonary Embolism(Through follow up (12 months))
- ICU Length of Stay(Until hospital discharge (an average of 6 days))
- Change in 6-minute Walk Test(Month 3, Month 12)
- Change in Shortness of Breath Questionnaire Score(Month 3, Month 12)
- Cost Effectiveness Analysis(Month 12)
研究者
Wissam Jaber
Associate Professor
Emory University