Dose-confirmatory Bridging Study in Total Knee Replacement

This is an interventional prevention trial for Venous Thromboembolism focused on measuring venous thromboembolism, prevention, orthopaedic surgery Read More

Inclusion Criteria:

• Male and female patients aged 20 years or above
• Patients undergoing elective TKR (the first replacement of the applicable knee joint)
• Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance

Exclusion Criteria:

• Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study

• History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk

  *: within 3 months prior to elective TKR for gastrointestinal bleeding

• Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
• Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
• Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
• Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
• Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
• Planned intermittent pneumatic compression during treatment period.