Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: Rivaroxaban short arm<br>7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]<br>* 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)<br>|
| Active Comparator: B: Rivaroxaban long arm<br>28 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. Subgroup: PK/PD parameters are assessed following the last intake of Rivaroxaban at day 28 | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with symptomatic or asymptomatic VTE | Assessed by ultrasound | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with symptomatic VTE within 28 days after bariatric surgery | Assessed by ultrasound | 28 days | 
| Number of patients with asymptomatic VTE within 28 days after bariatric surgery | Assessed by ultrasound | 28 days | 
| All cause mortality within 28 days after bariatric surgery |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rivaroxaban, Thromboembolic prophylaxis, Venous thromboembolism