Ultrasound-assisted treatment for acute pulmonary embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ASST GOM Niguarda
  Milan, Italia, Italy Recruiting

Study contacts

• Study coordinator: Alice Sacco, MD
• Email: alice.sacco@ospedaleniguarda.it
• Phone: 0039026444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.