Xarelto in the prevention of venous thromboembolism after knee or hip replacement surgery
Phase 4
- Conditions
- Health Condition 1: null- Prophylaxis of Venous Thromboembolism
- Registration Number
- CTRI/2011/07/001881
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 15000
Inclusion Criteria
Female and male patients who will undergo elective hip or knee arthroplasty.
Exclusion Criteria
Exclusion criteria must be read in conjunction with the local product information.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortalityTimepoint: Time Frame: During observation period of three months
- Secondary Outcome Measures
Name Time Method Risk benefit assessment of the drug in comparison to current standard therapyTimepoint: During observation period of three months