Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE
Pulmonary Embolism, Pulmonary Hypertension, Thromboembolism
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Alteplase, submassive pulmonary embolism, Thrombolysis, pulmonary catheter
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older, able to consent
- Submassive PE evidenced by CT showing saddle pulmonary embolism, central right and/or left main pulmonary artery emboli.
- Submassive PE confirmed by right ventricular dimension to left ventricular dimension ratio ≥ 1 in apical 4-chamber view echo/CT scan.
- Signs of RV dysfunction by echocardiogram, or elevated troponin I >0.04, or pro-BNP > 400 on serial measurements.
- PE symptom duration less than or equal to 14 days -
Exclusion Criteria:
- Age <18 to age >90 years;
- PE symptom duration >14 days;
- Administration of thrombolytic drugs in the last 4 days
Contraindications to thrombolytic therapy:
- Active bleeding disorder or coagulation disorder;
- Platelet count <100 000/mm3
- Hematocrit < 30%
- INR> 3
- Previous history of vitamin K antagonists with international normalized ratio >2.5 on admission
- History of intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleeding
- Intracranial neoplasm
- Arteriovenous malformation, or aneurysm
- Gastrointestinal bleeding <3 months
- Internal eye surgery or hemorrhagic retinopathy less than three-month duration
- Major surgery, cataract surgery, obstetric delivery, cardiopulmonary resuscitation, or invasive procedure less than10 days duration
- Allergy, hypersensitivity, or thrombocytopenia caused heparin or tPA
- Severe contrast allergy to iodinated contrast
- Large (>10 mm) right atrial or right ventricular thrombus
- Systolic blood pressure <90 mm Hg
- Severe hypertension on repeat measurement (systolic >180 mm Hg or diastolic >105 mm Hg)
- Pregnancy
- In any other investigational drug or device study
Inability to follow instructions or comply with treatment
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Sites / Locations
- Southside Northwell Hospital
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Peripheral low dose thrombolysis
Catheter directed acoustic thrombolysis
Peripheral low dose thrombolysis will use a peripheral vein into an arm as in routine intravenous therapy. This is the experimental arm. Alteplate (R-tpa) belong to thrombolytic or fibrnolytic drug class. Routine hospital policies for peripheral venous therapy will be used. A fixed dose of 24 mg of Activase (Atleplase) over 12 hours or 2.0 mg/hr will be administered peripherally. Simultaneously, intravenous unfractionated heparin will be given with a target partial thromboplastin time of 40 to 60 secs.
For ACDT, routine hospital protocols and EKOS(generic) will be used. EKOS is made up of 3 parts which include the drug delivery pulmonary artery catheter, a removable microsonic device, and a reusable Eko-Sonic control unit. Venous access will be obtained by ultrasound guidance in the internal jugular vein or femoral vein. After catheter placement, the right heart pressures will be measured. R-tpa will be directly given into the pulmonary catheter. A fixed dose of 24 mg of tpa over 12 hours or 2.0mg/hr will be given. For unilateral PE, a single catheter will be used with infusion rate of 2 mg//hr and two catheters will be used for bilateral PEs each with 1 mg /hr infusion rate. Intravenous unfractionated heparin will be given with a target partial thromboplastin time of 40 to 60 secs.