Submassive Pulmonary Embolism Experience With EKOS (SPEEK)

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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism; Thrombolytic Therapy; Thrombolysis; Mechanical Thrombolysis
• Intervention / Treatment: Device: EkoSonic Endovascular System

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Lisa K Stevens, MSN; Phone Number: 7406894426; Email: lisas@fmchealth.org
• Study Contact Backup: Name: Krishna Mannava, MD; Phone Number: 740-687-6910; Email: drkmannava@fmchealth.org

Study Locations

• United States
  • Ohio
    • Lancaster, Ohio, United States, 43130
      • Recruiting
      • Fairfield Medical Center
      • Contact: Lisa K Stevens, MSN; Phone Number: 740-689-4426; Email: lisas@fmchealth.org
      • Contact: Krishna Mannava, MD; Phone Number: 7406876910; Email: kmannava@fmchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of RV dysfunction	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	48 hours post catheter removal

Collaborators and Investigators

• Sponsor: Krishna Mannava, MD, FACS, RPVI
• Collaborators: EKOS Corporation
• Investigators: Study Director: Lisa K Stevens, MSN, Fairfield Medical Center; Principal Investigator: Krishna Mannava, MD, Fairfield Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pulmonary Embolism; Thrombolysis; Ultrasound Thrombolysis; Saddle PE; Submassive PE; Massive PE; Bilateral PE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: FMCspeekEKOSstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: De-identified individual study participant data will be made available 6 months after study completion. This data to include all primary and secondary outcome measures.