A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries

Inclusion Criteria

• Written informed consent
• Age ≥18 years and age ≤80 years
• Women body mass 50-110kg, men body mass 57-110 kg inclusive
• Patients who are planned for hip or knee replacement
• 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
• Ability of the patient, in the opinion of the investigator, to meet the Protocol requirements.

Exclusion Criteria

• 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
• Conditions and diseases in which there is a high risk of bleeding: cerebral aneurysm or aortic dissection, hemorrhagic stroke (including in history)
• Intractable hemorrhage
• 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
• Gastric or duodenal ulcer or other erosive and ulcerative lesions of gastrointestinal tract
• Recent ischemic stroke
• 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
• Diabetic or hemorrhagic retinopathy
• Decompensated diabetes mellitus, diabetes mellitus complications
• Recent delivery (during last 90 days)
• Bacterial endocarditis (acute or subacute)
• Pericarditis and pericardial effusion
• Renal and/or hepatic insufficiency
• Intrauterine contraception
• Surgeries or injuries of brain/spinal cord, spine, eyes, and major surgeries and injuries within 90 days prior to randomization)
• Spinal surgeries or its deformation in history of patients who are planned for epidural/spinal anesthesia
• Active liver diseases
• Anamnestic information about alcoholism, addiction or drug abuse over the last year
• Contraindications to surgeries
• Hemoglobin UNLх3; total bilirubin > UNLх1, 5 (unless other causal factors provided, such as Gilbert's syndrome)
• 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.)
• The use of dextrans or fibrinolytic therapy or other drugs affecting hemostasis;
• 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)
• Impossibility of contrast venography: contrast allergy, inability to install an intravenous catheter, etc
• Pregnancy, lactation period
• Donation of 450 ml or more of blood or plasma within 60 calendar days before inclusion enrolment
• Participation in clinical trials no less than 30 days before enrolment into this study or previous participation in this clinical study.