BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

Rate of Transfusions Due to Bleedings

Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.

Time frame: Day 1 (Day of surgery)

Number of Participants With Clinically Significant, Minor or Any Bleeding Events

Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as * Spontaneous skin haematoma larger than \>25 cm² * Wound haematoma \>100 cm² * Spontaneous nose bleed \>5 minutes * Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention * Spontaneous rectal bleeding (more than spot on toilet paper) * Gingival bleeding \>5 minutes * Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events.

Time frame: Treatment period (up to day 8+/-2 days visit)

Laboratory Analyses

Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Haematocrit \[%\]: (0.35-0.45) for women and (0.39-0.51) for men Haemoglobin \[g/dL\]: (11.6-15.4) for women and (13.2-17.3) for men White Blood Cell count \[10\^9/L\]: (4-10.3) for women and (3.9-10.3) for men Platelets \[10\^9/L\]: (145-420) for women and men Sodium \[mmol/L\]: (135-146) for women and men Potassium \[mmol/L\]: (3.5-5) for women and men Aspartate aminotransferase (AST) \[U/L\]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) \[U/L\]: (8-43) for women and (8-45) for men Alkaline Phosphatase \[U/L\]: (36-118) for women and (35-123) for men Creatinine \[mg/dL\]: (0.57-1.06)for women and (0.72-1.3) for men Bilirubin, total \[mg/dL\]: (0.22-1.28) for women and men Uric acid \[mg/dL\]: (2.4-6.47) for women and men

Time frame: Screening to end of treatment

Plasma Concentration (Cmax) of Dabigatran

Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state. Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state. Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state

Time frame: Day 1 to end of treatment

Area Under the Plasma Concentration-time Curve During a Dosing Interval

Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.

Time frame: up to day 8+/-2 days visit