Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 7, 2024

Keywords

ClinConnect Summary

The SONIC-PE clinical trial is studying a new treatment approach for patients with pulmonary embolism (PE), a serious condition where blood clots block blood flow in the lungs. This trial will involve patients who have been diagnosed with bilateral PE and are experiencing symptoms. The treatment being tested uses a special system to deliver a lower dose of a medication through a catheter, which is a thin tube inserted into a blood vessel. Researchers want to see how this treatment affects heart function and blood flow in the lungs, as well as to monitor any potential bleeding complications.

To participate in this trial, patients need to be at least 18 years old and show specific signs of PE, such as certain heart measurements and elevated levels of cardiac markers. However, individuals with certain medical conditions, such as recent major surgery, active bleeding, or specific heart and blood disorders, will not be eligible. Participants can expect to receive the treatment in a hospital setting and will be monitored closely for their health and any side effects. Overall, this trial aims to explore a promising treatment option for a serious condition that can affect many aspects of health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. patients at least 18 years of age,
• • 2. symptomatic PE defined as symptoms for \<14 days with normal systolic blood pressure (\>90 mmHg), RV-to-LV diameter ratio ≥0.9 on initial chest CT, bilateral filling defects located in at least 1 main or proximal lobar pulmonary artery, and cardiac troponin greater than the upper limit of normal (cTnI, cTnT, hsTnI, or hsTnT), AND
• • 3. in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis.
• Exclusion Criteria:
• • 1. stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year
• • 2. recent active bleeding from a major organ within 1 month
• • 3. major surgery within 7 days of screening
• • 4. contraindication to therapeutic anticoagulation
• • 5. systolic blood pressure \<90 mm Hg, systolic blood pressure drop by at least 40 mmHg over at least 15 minutes, shock, use of vasopressors, need for CPR, or need for ECMO
• • 6. need for mechanical ventilation, including non-invasive positive pressure ventilation
• • 7. hematocrit \<30%, platelet count \<100,000/μl
• • 8. international normalized ratio \>3
• • 9. serum creatinine \> 2 mg/dL
• • 10. liver cirrhosis
• • 11. known hypersensitivity to tPA, heparin, or any excipients
• • 12. perceived high risk for fatal or catastrophic bleeding
• • 13. prescription of dual antiplatelet therapy (DAPT) at time of screening
• • 14. Patients treated with any other advanced therapy, such as surgical embolectomy, catheter-based mechanical embolectomy, or fibrinolytic therapy, within the prior 30 days
• • 15. pregnancy or lactation