Conditions: Thromboembolism Arthroplasty, Replacement, Hip
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3494
Healthy volunteers: no

Brief summary:
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Detailed description:

Arms:
arm 1: daily dose 150 mg once daily, half a dose on the day of surgery arm 2: daily dose 220 mg once daily, half a dose on the day of surgery arm 3: 40 mg once daily

Interventions: intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: enoxaparin
Intervention descriptions: intervention 1: daily dose 150 mg once daily, half a dose on the day of surgery intervention 2: daily dose 150 mg once daily, half a dose on the day of surgery intervention 3: 40 mg once daily

Protocol document: