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Submassive Pulmonary Embolism Experience With EKOS (SPEEK)

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ClinicalTrials.gov Identifier: NCT02926742
Recruitment Status : Unknown
Verified October 2016 by Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center.
Recruitment status was:  Recruiting
First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
EKOS Corporation
Information provided by (Responsible Party):
Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center

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

Condition or disease Intervention/treatment
Thrombolytic Therapy Thrombolysis Mechanical Thrombolysis Pulmonary Embolism 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
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Submassive Pulmonary Embolism Experience With EKOS
Study Start Date : February 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: EkoSonic Endovascular System
    Ultrasound catheter-directed thrombolysis.


Primary Outcome Measures :
  1. Reduction of RV dysfunction [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926742


Contacts
Contact: Lisa K Stevens, MSN 7406894426 lisas@fmchealth.org
Contact: Krishna Mannava, MD 740-687-6910 drkmannava@fmchealth.org

Locations
United States, Ohio
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: Lisa K Stevens, MSN    740-689-4426    lisas@fmchealth.org   
Contact: Krishna Mannava, MD    7406876910    kmannava@fmchealth.org   
Sponsors and Collaborators
Krishna Mannava, MD, FACS, RPVI
EKOS Corporation
Investigators
Study Director: Lisa K Stevens, MSN Fairfield Medical Center
Principal Investigator: Krishna Mannava, MD Fairfield Medical Center

Responsible Party: Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center
ClinicalTrials.gov Identifier: NCT02926742     History of Changes
Other Study ID Numbers: FMCspeekEKOSstudy
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Keywords provided by Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center:
Thrombolysis
Ultrasound Thrombolysis
Pulmonary Embolism
Saddle PE
Submassive PE
Massive PE
Bilateral PE

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases