Phase
Condition
Chest Pain
Claudication
Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Acute symptomatic PE confirmed by CT, with filling defect in at least one main orsegmental 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 togive 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 >
Whichever measurement is chosen for inclusion criteria in addition to the MBSwill also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100)..
Exclusion
Exclusion Criteria:
Stroke or transient ischemic attack (TIA), head trauma, or other active intracranialor 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)
Pregnancy
Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days ofstudy enrollment
Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
Cardiac arrest (including pulseless electrical activity and asystole) requiring activecardiopulmonary resuscitation (CPR)
Evidence of irreversible neurological compromise
Life expectancy < 30 days
Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior toinclusion in the study
Study Design
Study Description
Connect with a study center
Fairfield Medical Center
Lancaster, Ohio 43130
United StatesActive - Recruiting

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