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
Krishna Mannava, MD, FACS, RPVI
Information provided by (Responsible Party):
Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho
Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo
Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
PE symptom duration < 21 days
Age >18 years
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)..
Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
Recent (within one month) or active bleeding from a major organ
Hemoglobin (Hgb) < 8.0
Platelets < 60 thousand/µL
Major surgery within seven days
Clinician deems high-risk for catastrophic bleeding
History of heparin-induced thrombocytopenia (HIT)
Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
Evidence of irreversible neurological compromise
Life expectancy < 30 days
Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study