A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Using femoral or jugular vein access the mechanical blood clots fragmentation by PigTail 6F catheter circular rotational movements. For unilateral thromboembolism, the PigTail catheter is positioned in the obstructed branch of the pulmonary artery, 1 mg of alteplase is injected as a bolus, followed by a micro-jet injection of 1 mg/hour. For bilateral thromboembolism, the PigTail catheter is positioned in the pulmonary trunk with a bolus of 2 mg alteplase followed by an infusion of 2 mg/hour. The total duration of infusion will be 9 hours, the total dose of alteplase will be 10 mg for unilateral lesions and 20 mg for bilateral lesions. During the alteplase infusion, unfractionated heparin is continued with a target activated partial thromboplastin time (aPTT) of 50 to 60 seconds. After completion of the procedure, UFH therapy is continued for 24 hours, followed by a change to oral anticoagulants.
Therapy with UFH with targeted аPTT lasts for 24 hours (no more than 48 hours in total). Then the change to oral anticoagulants is performed
Almazov National Medical Research Centre
Saint Petersburg, Russia
RECRUITINGA decrease in the ratio of RV/LV diameters
A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy
Time frame: 48 ± 6 hours
Mortality
Mortality
Time frame: 90 days
Cardiorespiratory decompensation or collapse
necessity of inotropic and vasopressor support; cardiac arrest or need for CPR; obstructive shock, placement on extracorporeal membrane oxygenation (ECMO), intubation, or initiation of non-invasive mechanical ventilation
Time frame: 7 days
Major bleeding events
International Society on Thrombosis and Hemostasis (ISTH) major bleeding
Time frame: 7 days
PE thrombus load reduction
Qanadli score by CT-scan
Time frame: 48 hours
The degree of residual pulmonary artery thrombosis with perfusion deficiency
The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan
Time frame: 180 days
Post-pulmonary embolism syndrome formation
The presence of symptomatic pulmonary artery residual thrombosis
Time frame: 180 days
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