Mechanical Thrombolysis, Pulmonary Embolism, Thrombolysis, Thrombolytic Therapy
Conditions
Keywords
Thrombolysis, Ultrasound Thrombolysis, Pulmonary Embolism, Saddle PE, Submassive PE, Massive PE, Bilateral PE
Brief summary
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
Detailed description
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.
Interventions
Ultrasound catheter-directed thrombolysis.
Sponsors
Krishna Mannava, MD, FACS, RPVI
EKOS Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery. 2. RV dysfunction as evidenced by RV/LV ratio \> 0.9 on echo 3. Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent 4. PE symptom duration \< 21 days 5. Age \>18 years 6. 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 \> 100. 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)..
Exclusion criteria
1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year 2. Recent (within one month) or active bleeding from a major organ 3. Hemoglobin (Hgb) \< 8.0 4. Platelets \< 60 thousand/µL 5. Major surgery within seven days 6. Clinician deems high-risk for catastrophic bleeding 7. History of heparin-induced thrombocytopenia (HIT) 8. Pregnancy 9. Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment 10. Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support 11. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) 12. Evidence of irreversible neurological compromise 13. Life expectancy \< 30 days 14. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of RV dysfunction | 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 |
Countries
United States
Contacts
Primary ContactLisa K Stevens, MSN
Backup ContactKrishna Mannava, MD
Outcome results
None listed