NCT03522259

Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Bariatric Surgery

Interventions

Type	Name	Description
DRUG	Rivaroxaban 10 MG Oral Tablet [Xarelto]	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)

Timeline

• Start date: 2018-07-19
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-05-11
• Last updated: 2024-11-13

Locations

3 sites across 1 country: Switzerland