Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE
Running, not enrolling · Phase 4
Conditions studied: Pulmonary Embolism, Pulmonary Hypertension, Thromboembolism, Right Ventricular Dysfunction
In brief
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)
Key facts
- Study ID
- NCT03581877
- Run by
- Northwell Health
- People needed
- 31
- Starts
- 2019-01-28
- Expected to finish
- 2025-03-19
- Last updated by the study team
- 2024-10-03
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 -
You may not qualify if…
- 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
Where it is running
- Southside Northwell Hospital — Bay Shore, New York, United States
- Long Island Jewish Medical Center — Queens, New York, United States
Full record on ClinicalTrials.gov
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