Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Age 18 years or older, able to consent

2. Submassive PE evidenced by CT showing saddle pulmonary embolism, central right and/or left main pulmonary artery emboli.

3. Submassive PE confirmed by right ventricular dimension to left ventricular dimension ratio ≥ 1 in apical 4-chamber view echo/CT scan.

4. Signs of RV dysfunction by echocardiogram, or elevated troponin I >0.04, or pro-BNP > 400 on serial measurements.

5. PE symptom duration less than or equal to 14 days -

Exclusion Criteria:

1. Age <18 to age >90 years;

2. PE symptom duration >14 days;

3. Administration of thrombolytic drugs in the last 4 days

4. Contraindications to thrombolytic therapy:

1. Active bleeding disorder or coagulation disorder;

2. Platelet count <100 000/mm3

3. Hematocrit < 30%

4. INR> 3

5. Previous history of vitamin K antagonists with international normalized ratio >2.5 on admission

6. History of intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleeding

7. Intracranial neoplasm

8. Arteriovenous malformation, or aneurysm

9. Gastrointestinal bleeding <3 months

10. Internal eye surgery or hemorrhagic retinopathy less than three-month duration

11. Major surgery, cataract surgery, obstetric delivery, cardiopulmonary resuscitation, or invasive procedure less than10 days duration

12. Allergy, hypersensitivity, or thrombocytopenia caused heparin or tPA

5. Severe contrast allergy to iodinated contrast

6. Large (>10 mm) right atrial or right ventricular thrombus

7. Systolic blood pressure <90 mm Hg

8. Severe hypertension on repeat measurement (systolic >180 mm Hg or diastolic >105 mm Hg)

9. Pregnancy

10. In any other investigational drug or device study

11. Inability to follow instructions or comply with treatment

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