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Clinical trial

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

ID
Name
UVCMBS003
Description
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.
Trial arms
Trial start
2018-07-19
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Phase
Early phase I
Treatment
Rivaroxaban 10 MG Oral Tablet [Xarelto]
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)
Arms:
A: Rivaroxaban short arm, B: Rivaroxaban long arm
Size
272
Primary endpoint
Number of patients with symptomatic or asymptomatic VTE
28 days
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 272, 'type': 'ACTUAL'}}
Updated at
2024-02-13

1 organization

1 product

1 indication

Organization
Insel Gruppe
Product
Rivaroxaban
Indication
Weight Loss Surgery