Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Bayer; Bayer (collaborator); Janssen Pharmaceuticals; Janssen Pharmaceuticals (collaborator)
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions

• Written informed consent

Exclusion Criteria:

• DVT and/or PE in the patient history

• Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry

• Uncontrolled hypertension