Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

Exclusion Criteria

• •1. Pregnancy at the time of screening.
• •2. Indication for anticoagulation other than post-operative thromboprophylaxis.
• •3. Active bleeding or high risk of bleeding.
• •4. Anticipated continued use of neuraxial catheter after surgery.
• •5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
• •6. Uncontrolled hypertension.
• •7. Impaired liver function (transaminase \>3 X ULN) or history of hepatic insufficiency.
• •8. Creatinine clearance \<30 mL/min.
• •9. Antiplatelet agents other than low dose aspirin (\< 200mg).
• •10. The use of intermittent pneumatic compression.
• •11. Known hypersensitivity to contrast media or rivaroxaban.
• •12. Known drug or alcohol abuse.
• •13. Active malignant disease or current cytostatic treatment.
• •14. Stroke within the previous month.
• •15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
• •16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.