Pulmonary Embolism Clinical Trial
— SUNSET sPEOfficial title:
Comparison of Standard Catheter Directed Thrombolysis vs. Ultrasound Assisted Thrombolysis for Patients With Acute Submassive Pulmonary Embolism
NCT number | NCT02758574 |
Other study ID # | PRO15090058 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | August 2021 |
Verified date | September 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will compare standard catheter directed thrombolysis to ultrasound accelerated thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study population will include patients eligible for catheter directed thrombolysis (CDT) for submassive PE. Subjects will be randomized to, either, standard catheter-directed thrombolysis or ultrasound-accelerated thrombolysis (USAT).
Status | Completed |
Enrollment | 77 |
Est. completion date | August 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Criteria: Inclusion Criteria: - Subject is eligible for catheter directed thrombolysis per the study protocol for submassive 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) and without the need of catecholamine support or cardiopulmonary resuscitation). Exclusion Criteria: - pregnancy; - index PE symptom duration >14 days; - high bleeding rsk (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. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Mercy | Pittsburgh | Pennsylvania |
United States | UPMC Passavant | Pittsburgh | Pennsylvania |
United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
United States | UPMC Shadyside | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis | 48 hours | ||
Secondary | Mortality | 90 days | ||
Secondary | Stroke | Any ischemic or hemorrhagic stroke | 30 days | |
Secondary | Major Bleeding | Any major bleeding event defined as hemorrhagic stroke, need to transfuse or need to intervene | 30 days | |
Secondary | Echocardiographic Right Ventricular/Left Ventricular Diameter (ratio) | 12 months | ||
Secondary | Functional status (6 min walk test) | 6 min walk test (meters) | 12 months | |
Secondary | Cost effectiveness analysis | Quality Adjusted Life Years - Costs based on in-hospital resource utilization and out-of hospital care and follow-up. | 12 months | |
Secondary | Echocardiographic Tricuspid Annular Plane Systolic Excursion (cm) | 12 months | ||
Secondary | Quality of life Questionnaire SF36 (score) | 12 months | ||
Secondary | Quality of life Questionnaire PE QOL (score) | 12 months | ||
Secondary | Quality of life Questionnaire San Diego Shortness of Breath (score) | 12 months |
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