Conditions: Arthroplasty, Replacement Prevention of Venous Thromboembolism Moderate Renal Impairment (CrCl 30-50 mL/Min)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 142
Healthy volunteers: no

Brief summary:
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

Detailed description:

Arms:
arm 1: open label, once daily dose approved by EMEA and Health Canada

Interventions: intervention 1: Dabigatran etexilate
Intervention descriptions: intervention 1: once daily approved dose by EMEA and Health Canada

Protocol document: