Status:
COMPLETED
Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis
Lead Sponsor:
Corewell Health West
Collaborating Sponsors:
EKOS Corporation
Conditions:
Submassive Pulmonary Embolism
Eligibility:
All Genders
18-80 years
Brief Summary
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \> 90.
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01899339
Start Date
May 1 2013
End Date
February 1 2019
Last Update
July 18 2023
Active Locations (1)
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1
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503