Status:
RECRUITING
Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
Lead Sponsor:
Niguarda Hospital
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Acute pulmonary embolism (PE) is a potentially life-threatening disease spanning a wide spectrum of clinical outcomes. PE is the third most common cardiovascular disorder in Europe and USA and causes ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06143969
Start Date
November 28 2022
End Date
March 31 2027
Last Update
November 22 2023
Active Locations (1)
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1
ASST GOM Niguarda
Milan, Italia, Italy, 20162