A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Inclusion criteria Inclusion criteria

1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
2. Male or Female 20 years of age or order
3. Patients weighing at least 40 kg
4. Written informed consent prior to the start of study participation

Exclusion criteria Exclusion criteria

1. History of bleeding diathesis
2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
3. Major surgery or trauma (e.g. hip fracture) within the last 3 months
4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
5. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
6. Condition requiring anti-coagulant therapy
7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
8. Patients with a history of clinically significant renal diseases or with elevated creatinine values