Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery (BARIVA)
BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Baden, Switzerland
- Kantonsspital Baden
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Bern, Switzerland
- Clinic Beau-Site
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Berne, Switzerland, 3010
- University Hospital, Inselspital Berne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A: Rivaroxaban short arm
7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
|
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)
|
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Active Comparator: B: Rivaroxaban long arm
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 |
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with symptomatic or asymptomatic VTE
Time Frame: 28 days
|
Assessed by ultrasound
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28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with symptomatic VTE within 28 days after bariatric surgery
Time Frame: 28 days
|
Assessed by ultrasound
|
28 days
|
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Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Time Frame: 28 days
|
Assessed by ultrasound
|
28 days
|
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All cause mortality within 28 days after bariatric surgery
Time Frame: 28 days
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28 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guido Stirnimann, MD, Berne, University Hospital, University of Berne, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVCMBS003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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