Active — Not RecruitingPhase 4

Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE

United States31 participantsStarted 2019-01-28

Plain-language 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)

Who can participate

Age range18 Years – 89 Years

SexALL

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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

What they're measuring

Right ventricle (RV) to Left ventricle (LV) ratio

Timeframe: 48 hours

Pulmonary pressures

Timeframe: 48 hours

Trial details

NCT IDNCT03581877

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-19

View on ClinicalTrials.gov More Pulmonary Embolism trials