Long Term Study Looking at the Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:May 2013
End Date:May 2014

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Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an
improved right ventricular function 72 hours post treatment.


Inclusion Criteria:

- Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of
the thorax with embolus involving at least one main or lower lobe pulmonary artery
and RV:LV ratio > 0.9

Exclusion Criteria:

- age > 80

- Recent thrombolytic therapy (with in 4 days)

- Active bleeding or know bleeding diathesis

- Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or
PTT > 50

- Thrombocytopenia (PLT cound < 100,000)

- History of any intracranial or intraspinal surgery, trauma or bleed

- Intracranial neoplasms, AVM, or aneurysm

- Recent (< 1 month) GI bleed

- Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy

- Recent (< 7 days) major surgery, trauma, or obstetrical delivery

- Renal insufficiency with eGFR < 45 ml/min

- Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA

- Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP
> 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.

- Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.

- Pregnant patients

- known right to left shunt

- Large (>10 mm)intracardiac thrombus

- Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of
inclusion.

- Life expectancy < 30 days
We found this trial at
1
site
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
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