Overview

Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborators:
Bayer
Bayer (collaborator)
Janssen Pharmaceuticals
Janssen Pharmaceuticals (collaborator)
Treatments:
Rivaroxaban