Bariatric Surgery Clinical Trial
— BARIVAOfficial title:
BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
Verified date | February 2024 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 272 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Baden | Baden | |
Switzerland | Clinic Beau-Site | Bern | |
Switzerland | University Hospital, Inselspital Berne | Berne |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | Bayer, Janssen Pharmaceuticals |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with symptomatic or asymptomatic VTE | Assessed by ultrasound | 28 days | |
Secondary | Number of patients with symptomatic VTE within 28 days after bariatric surgery | Assessed by ultrasound | 28 days | |
Secondary | Number of patients with asymptomatic VTE within 28 days after bariatric surgery | Assessed by ultrasound | 28 days | |
Secondary | All cause mortality within 28 days after bariatric surgery | 28 days |
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