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Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery (BARIVA)

Primary Purpose

Bariatric Surgery

Status
Active
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Rivaroxaban 10 MG Oral Tablet [Xarelto]
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery focused on measuring Rivaroxaban, Thromboembolic prophylaxis, Venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A: Rivaroxaban short arm

B: Rivaroxaban long arm

Arm Description

7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.

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

Outcomes

Primary Outcome Measures

Number of patients with symptomatic or asymptomatic VTE
Assessed by ultrasound

Secondary Outcome Measures

Number of patients with symptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
All cause mortality within 28 days after bariatric surgery

Full Information

First Posted
April 30, 2018
Last Updated
December 14, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bayer, Janssen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03522259
Brief Title
Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery
Acronym
BARIVA
Official Title
BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bayer, Janssen Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery
Keywords
Rivaroxaban, Thromboembolic prophylaxis, Venous thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Rivaroxaban short arm
Arm Type
Active Comparator
Arm Description
7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
Arm Title
B: Rivaroxaban long arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 10 MG Oral Tablet [Xarelto]
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of patients with symptomatic or asymptomatic VTE
Description
Assessed by ultrasound
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of patients with symptomatic VTE within 28 days after bariatric surgery
Description
Assessed by ultrasound
Time Frame
28 days
Title
Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Description
Assessed by ultrasound
Time Frame
28 days
Title
All cause mortality within 28 days after bariatric surgery
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Stirnimann, MD
Organizational Affiliation
Berne, University Hospital, University of Berne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
Country
Switzerland
Facility Name
University Hospital, Inselspital Berne
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Clinic Beau-Site
City
Bern
Country
Switzerland

12. IPD Sharing Statement

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Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

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