Ultrasound-assisted treatment for acute pulmonary embolism
Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism (USAT IH-PE): Impact on Short- and Long-term Outcome, a Multi-center Experience. An Observational Retrospective and Prospective Multi-center Study
This study is testing if using ultrasound to help break up blood clots in patients with serious pulmonary embolism can reduce the chances of developing high blood pressure in the lungs within six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT06143969 on ClinicalTrials.gov |
What this trial studies
This study evaluates the incidence of pulmonary hypertension within six months following ultrasound-assisted, catheter-directed thrombolysis in patients with acute intermediate-high-risk pulmonary embolism. It includes both retrospective and prospective data collection from multiple centers. The study aims to clarify the effectiveness of this treatment approach, which combines ultrasound technology with targeted thrombolysis to potentially improve outcomes for patients at risk of severe complications from pulmonary embolism.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with acute intermediate-high-risk pulmonary embolism who meet specific clinical criteria outlined by the European Society of Cardiology.
Not a fit: Patients under 18 years old, those unable to provide informed consent, or those with certain bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce the incidence of pulmonary hypertension and improve recovery outcomes for patients with acute pulmonary embolism.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using catheter-directed therapies for pulmonary embolism, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines * Symptoms onset within previous 14 days associated or not with deep venous thrombosis * Confirmation of the PE by contrast-enhanced computed tomography of the chest with embolus located in at least one main or proximal lower lobe pulmonary artery * Echocardiographic parameters of RV disfunction * Patients with high-risk PE or hemodynamic deterioration on anticoagulation, who have absolute contraindications (high bleeding risk) to systemic thrombolysis and symptoms onset during the last 14 days. Patients with surgery-related embolic complications are also included (within 48 hours). Exclusion Criteria * Age \< 18 years old * Patients unable to give informed consent * Pregnancy * Patients received fibrinolytic drugs in the preceding 4 days * Bleeding diathesis * Known bleeding disorder * Low platelet count (\< 100.000/uL * Gastrointestinal bleeding in the preceding 3 month * Any ongoing known presence of malignant neoplasia months * Advanced chronic kidney disease (defined as 11.000/uL) * Gastrointestinal bleeding in the preceding 3 month * Any ongoing known presence of malignant neoplasia at admission with survival rate \< 6 * Advanced chronic kidney disease (defined as eGFR \< 30 ml/min or on dialysis)
Where this trial is running
Milan, Italia
- ASST GOM Niguarda — Milan, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Alice Sacco, MD
- Email: alice.sacco@ospedaleniguarda.it
- Phone: 0039026444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.