Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
Massive Pulmonary Embolism
About this trial
This is an interventional treatment trial for Massive Pulmonary Embolism focused on measuring Massive pulmonary embolism, Fibrinolysis, Recombinant Non-immunogenic Staphylokinase
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18 and over
- Verified diagnosis of massive PE (using MSCT with PA contrast)
- Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
- women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
- men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility)
- Availability of signed and dated informed consent of the patient to participate in the study.
Exclusion Criteria:
• Increased risk of bleeding:
- Extensive bleeding at present or within the previous 6 months, hemorrhagic diathesis;
- Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;
- A history of hemorrhagic stroke or stroke of unknown etiology;
- Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;
- A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);
- Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
- Long-term or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible blood vessel (eg, subclavian or jugular vein);
- Severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
- Confirmed gastric or duodenal ulcer within the last three months;
- Neoplasm with an increased risk of bleeding;
- Concurrent administration of oral anticoagulants, for example, warfarin with an INR> 1.3;
- Arterial aneurysms, developmental defects of arteries / veins;
- Severe uncontrolled arterial hypertension;
- Acute pancreatitis;
- Bacterial endocarditis, pericarditis;
- suspicion of aortic dissecting aneurysm;
- any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.
- Lactation, pregnancy
- Known hypersensitivity to Alteplase, Fortelizin.
Sites / Locations
- V.F. Dolgopolov Vyselki Central District Hospital
- Sergiyev Posad Regional Clinical Hospital
- Belgorod Regional Clinical Hospital of St. Joseph
- Kuzbass Cardiology center
- Krasnoyarsk Regional Clinical Hospital
- Kursk Regional Clinical Hospital
- D.D. Pletnev City Clinical Hospital
- I.V. Davydovskii City Clinical Hospital
- S.S. Yudin City Clinical Hospital
- V.V. Vinogradov City Clinical Hospital
- V.V. Veresaev City Clinical Hospital
- N.V. Sklifosovsky Research Institute for Emergency Medicine
- S.P. Botkin City Clinical Hospital
- Murmansk Regional Clinical Hospital
- N.N. Burdenko Penza Regional Clinical hospital
- G.A. Zakharyin Clinical hospital №6
- Saint Petersburg "Mariinskaya" City Hospital
- Holy Martyr Elizabeth Saint Petersburg City Hospital
- V.P. Polyakov Samara Regional Clinical Cardiology Dispensary
- Saratov Regional Clinical Cardiology Dispensary
- Tver Regional Clinical Hospital
- City Clinical hospital №4
- City Clinical Hospital of Emergency №25
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Recombinant nonimmunogenic staphylokinase
Alteplase
lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.
Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.