Clinical trial NCT02926742: Submassive Pulmonary Embolism Experience With EKOS
Official title: Submassive Pulmonary Embolism Experience With EKOS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombolytic Therapy
Thrombolysis
Mechanical Thrombolysis
Pulmonary Embolism
Keywords: Thrombolysis
Ultrasound Thrombolysis
Pulmonary Embolism
Saddle PE
Submassive PE
Massive PE
Bilateral PE
Lead sponsor: Fairfield Medical Center
Sponsor class: OTHER
Collaborators: name: EKOS Corporation
First posted: 2016-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of RV dysfunction
timeFrame: 48 hours post catheter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
Study officials:
affiliation: Fairfield Medical Center
name: Lisa K Stevens, MSN
role: STUDY_DIRECTOR
affiliation: Fairfield Medical Center
name: Krishna Mannava, MD
role: PRINCIPAL_INVESTIGATOR
References: