Conditions: Arthroplasty, Replacement, Knee Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2615
Healthy volunteers: no

Brief summary:
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Detailed description:

Arms:
arm 1: low dose regimen taken once daily arm 2: high dose regimen taken once daily arm 3: 30 mg subcutaneously twice daily

Interventions: intervention 1: Dabigatran Dose 1 - day 2 to completion intervention 2: Dabigatran Dose 1 - day 1 intervention 3: Dabigatran Dose 2 - day 2 to completion intervention 4: Dabigatran Dose 2 - day 1 intervention 5: Enoxaparin
Intervention descriptions: intervention 1: low dose regimen taken once daily intervention 2: low dose regimen taken once daily intervention 3: high dose regimen taken once daily intervention 4: high dose regimen taken once daily intervention 5: 30 mg subcutaneously twice daily

Protocol document: