The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. The objectives are to assess the safety and feasibility of venous thromboembolism (VTE) prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days. All clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to detect clinically inapparent thromboses. 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
272
Rivaroxaban 10mg per os is started on the first postoperative day. Patients receive Rivaroxaban 10mg QD for 7days (short arm) or 28 days (long arm)
Kantonsspital Baden
Baden, Switzerland
University Hospital, Inselspital Berne
Bern, Switzerland
Clinic Beau-Site
Bern, Switzerland
Number of patients with symptomatic or asymptomatic VTE
Assessed by ultrasound
Time frame: 28 days
Number of patients with symptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
Time frame: 28 days
Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
Time frame: 28 days
All cause mortality within 28 days after bariatric surgery
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.