RecruitingNCT06143969

Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk 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

Sponsor

Niguarda Hospital

Enrollment

180 participants

Start Date

Nov 28, 2022

Study Type

OBSERVATIONAL

Conditions

Pulmonary Embolism

Summary

The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria13

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)

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Interventions

PROCEDUREultrasound-assisted, catheter-directed thrombolysis

After 10 hours of alteplase infusion and EKOSTM ultrasound, the therapy is stopped, the EKOSTM catheter is removed, and the puncture site (internal jugular vein or femoral vein) has to be compressed.