Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bariatric Surgery
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. Rivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. Especially in ...
The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. Rivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. The objectives are to assess the safety and feasibility of VTE prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days. In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.
Tracking Information
- NCT #
- NCT03522259
- Collaborators
- Bayer
- Janssen Pharmaceuticals
- Investigators
- Principal Investigator: Guido Stirnimann, MD Berne, University Hospital, University of Berne, Switzerland
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