Pulmonary Embolism Acute
Conditions
Keywords
acute pulmonary embolism, catheter-directed thrombolysis, anticoagulant therapy
Brief summary
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
Interventions
COMBINATION_PRODUCTStandard Catheter-Directed Low Dose Thrombolysis
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
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients will be randomized into 2 parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset \< 14 days prior * Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio \>1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level * Signed informed consent
Exclusion criteria
* High-risk pulmonary embolism * Thrombus in the heart chambers on TTE * Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins; * Haemoglobin level \< 70 g/L, platelet count ≤ 100 x 109 * Allergic to alteplase or UFH or contrast allergy * Pregnant or breastfeeding * Clinically significant malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A decrease in the ratio of RV/LV diameters | 48 ± 6 hours | A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory decompensation or collapse | 7 days | 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 |
| Major bleeding events | 7 days | International Society on Thrombosis and Hemostasis (ISTH) major bleeding |
| Mortality | 90 days | Mortality |
| The degree of residual pulmonary artery thrombosis with perfusion deficiency | 180 days | The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan |
| Post-pulmonary embolism syndrome formation | 180 days | The presence of symptomatic pulmonary artery residual thrombosis |
| PE thrombus load reduction | 48 hours | Qanadli score by CT-scan |
Countries
Russia
Contacts
Primary ContactOlga Moiseeva
Backup ContactMaria Simakova
Outcome results
None listed