Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

Summary

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.

Timeline

Start

2018-07-19

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Kroll D, Nett PC, Rommers N, Borbely Y, Deichsel F, Nocito A, Zehetner J, Kessler U, Fringeli Y, Alberio L, Candinas D, Stirnimann G. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315241. doi: 10.1001/jamanetworkopen.2023.15241.
• Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.

Drugs

Indications

No indication recorded.