A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Sodium Enoxaparine
Intervention description: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Deep vein thrombosis; Prophylaxis; Sodium enoxaparin

Summary:

      The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan
      for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent

          2. Age ≥18 years and age ≤80 years

          3. Women body mass 50-110kg, men body mass 57-110 kg inclusive

          4. Patients who are planned for hip or knee replacement

          5. Willingness of patients of both sexes and their sexual partners with preserved
             reproductive function to use reliable methods of contraception, starting from
             screening and up to 4 weeks after the last dose of the studied drug. This requirement
             does not apply to patients who underwent surgical sterilization. Reliable methods of
             contraception involves a 1-barrier method combined with one of the following:
             spermicides/oral contraceptive

          6. Ability of the patient, in the opinion of the investigator, to meet the Protocol
             requirements.

        Exclusion Criteria:

          1. Hypersensitivity to the components included in the formula of preparation BCD-080
             (CJSC BIOCAD) Clexane (Sanofi-Avensis France, France) or medications of the same class

          2. Conditions and diseases in which there is a high risk of bleeding: cerebral aneurysm
             or aortic dissection, hemorrhagic stroke (including in history)

          3. Intractable hemorrhage

          4. History of documented diseases of blood coagulation (hemophilia A or B, Willebrand
             disease and other coagulopathies, idiopathic thrombocytopenic purpura, Heparin induced
             thrombocytopenia associated with thrombosis or without it, thrombohemorrhagic
             syndrome, etc.) in anamnesis and/or at the moment of examination

          5. Gastric or duodenal ulcer or other erosive and ulcerative lesions of gastrointestinal
             tract

          6. Recent ischemic stroke

          7. Uncontrolled severe hypertension; that is, all cases of hypertension, in which blood
             pressure decrease cannot be achieved with the use of combination of 3 antihypertensive
             drugs, compulsorily including a diuretic, and non-drug methods of correction
             (salt-free diet, graduated exercise); or if the results of two successive measurements
             of supine arterial blood pressure with an interval of 15-30 minutes, systolic blood
             pressure> 180 mm Hg. or diastolic blood pressure> 105 mm Hg

          8. Diabetic or hemorrhagic retinopathy

          9. Decompensated diabetes mellitus, diabetes mellitus complications

         10. Recent delivery (during last 90 days)

         11. Bacterial endocarditis (acute or subacute)

         12. Pericarditis and pericardial effusion

         13. Renal and/or hepatic insufficiency

         14. Intrauterine contraception

         15. Surgeries or injuries of brain/spinal cord, spine, eyes, and major surgeries and
             injuries within 90 days prior to randomization)

         16. Spinal surgeries or its deformation in history of patients who are planned for
             epidural/spinal anesthesia

         17. Active liver diseases

         18. Anamnestic information about alcoholism, addiction or drug abuse over the last year

         19. Contraindications to surgeries

         20. Hemoglobin <100 g/l

         21. Platelet count <100х10*9/l

         22. Creatine clearance <30 ml/min

         23. Biochemical blood assay indexes: AST/ALT > UNLх3; total bilirubin > UNLх1,5 (unless
             other causal factors provided, such as Gilbert's syndrome)

         24. Necessity for continued treatment with anticoagulants (except for planned under this
             study), antiaggregant and fibrinolytics (eg, patients with artificial cardiac valve,
             atrial fibrillation patients receiving warfarin, etc.)

         25. The use of dextrans or fibrinolytic therapy or other drugs affecting hemostasis;

         26. Necessity for use of systemic glucocorticosteroids and non-steroidal anti-inflammatory
             drugs (except for the use of the latter with the purpose of anaesthesia in the early
             postoperative period - during 3 days after the planned hip or knee replacement)

         27. Impossibility of contrast venography: contrast allergy, inability to install an
             intravenous catheter, etc

         28. Pregnancy, lactation period

         29. Donation of 450 ml or more of blood or plasma within 60 calendar days before inclusion
             enrolment

         30. Participation in clinical trials no less than 30 days before enrolment into this study
             or previous participation in this clinical study.