Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Inclusion criteria

• Male or female, age ≥ 18 years;
• Planned total knee replacement surgery;
• Signed informed consent form;
• Willing to comply with the protocol;
• Willing to use adequate contraception during the trial.

Exclusion criteria

• Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
• History of venous thrombosis of any location or PE
• History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
• History of evident coagulopathy or in a relative
• Congenital thrombophilia
• Bleeding within 6 months of screening; increased risk of bleeding
• BMI less than 18,5 or more than 40 kg/m2
• Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes
• Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
• Platelets < 100 000/mm3
• Clinical significant abnormalities of APTT and/or INR
• GFR < 30 ml/min/1.73 m2
• ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN