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: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

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: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Baden, Switzerland
    • Kantonsspital Baden
  • Bern, Switzerland
    • Clinic Beau-Site
  • Berne, Switzerland, 3010
    • University Hospital, Inselspital Berne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

2

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.	Drug: 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)
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	Drug: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Bayer; Janssen Pharmaceuticals
• Investigators: Principal Investigator: Guido Stirnimann, MD, Berne, University Hospital, University of Berne, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rivaroxaban; Venous thromboembolism; Thromboembolic prophylaxis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: UVCMBS003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No