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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Catheter-Directed Thrombolysis | Experimental | Local, standard catheter-directed thrombolysis with a total alteplase dose of 10 mg (for unilateral lesion) or 20 mg (for bilateral lesion) administered over 9 hours |
|
| Standard Anticoagulation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Catheter-Directed Low Dose Thrombolysis | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| A 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 | 48 ± 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Moiseeva | Contact | +79213068249 | moiseeva_om@almazovcentre.ru | |
| Maria Simakova | Contact | +79215898763 | simakova_ma@almazovcentre.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almazov National Medical Research Centre | Recruiting | Saint Petersburg | 197341 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31504429 | Background | Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available. |
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patients will be randomized into 2 parallel groups
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|
| Standard Anticoagulation | Drug | 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 |
|
| 7 days |
| Major bleeding events | International Society on Thrombosis and Hemostasis (ISTH) major bleeding | 7 days |
| PE thrombus load reduction | Qanadli score by CT-scan | 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 | 180 days |
| Post-pulmonary embolism syndrome formation | The presence of symptomatic pulmonary artery residual thrombosis | 180 days |
| ID | Term |
|---|---|
| D005343 | Fibrinolytic Agents |
| ID | Term |
|---|---|
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D006401 | Hematologic Agents |
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