Thrombolysis Methods for Blood Clots in the Lung
Recruiting at 1 trial location
AS
Overseen ByAzhar Supariwala, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
To determine whether peripheral low dose systemic thrombolysis (PLST) is non-inferior to catheter directed acoustic pulse thrombolysis (ACDT) in improving RV function and reducing pulmonary artery pressures in submassive pulmonary embolism (PE)
Research Team
AS
Azhar Supariwala, MD
Principal Investigator
Southside Northwell Hospital
Eligibility Criteria
This trial is for adults over 18 with a condition called submassive pulmonary embolism (PE), which involves blood clots in the lungs causing heart issues. Participants must have specific signs of heart strain and be within two weeks of PE symptom onset. Those with minor or resolved symptoms, or other health conditions that could interfere are not eligible.Inclusion Criteria
My symptoms of pulmonary embolism have been present for 14 days or less.
Signs of RV dysfunction by echocardiogram, or elevated troponin I >0.04, or pro-BNP > 400 on serial measurements.
My heart scan shows a specific type of lung clot.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either peripheral low dose systemic thrombolysis (PLST) or catheter directed acoustic pulse thrombolysis (ACDT) for submassive pulmonary embolism
12-24 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measurements of RV:LV ratio and pulmonary pressures
30 days
2 visits (in-person)
Treatment Details
Interventions
- Alteplase
- EKOS
Trial Overview The study compares two treatments for breaking up blood clots in the lungs: peripheral low dose systemic thrombolysis (PLST) using drugs to dissolve clots throughout the body, versus catheter directed acoustic pulse thrombolysis (ACDT) targeting clot areas directly. It aims to see if PLST is just as effective as ACDT at improving heart function and lowering lung artery pressure.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Peripheral low dose thrombolysisExperimental Treatment1 Intervention
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.
Group II: Catheter directed acoustic thrombolysisActive Control1 Intervention
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.
Alteplase is already approved in United States, European Union for the following indications:
Approved in United States as Activase for:
- Acute ischemic stroke
- Acute myocardial infarction
- Pulmonary embolism
- Blocked central venous catheter
Approved in European Union as Actilyse for:
- Acute ischemic stroke
- Acute myocardial infarction
- Pulmonary embolism
- Blocked central venous catheter
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Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Trials
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Recruited
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