BARIVA: Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03522259
• Collaborator: Bayer (Industry), Janssen Pharmaceuticals (Industry)
• Enrollment: 260
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 53.4
• Patients Per Site: 86.7
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery	Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
• Actual Study Start Date: Jul 19, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Number of patients with symptomatic or asymptomatic VTE [28 days]

   Assessed by ultrasound

Secondary Outcome Measures

1. Number of patients with symptomatic VTE within 28 days after bariatric surgery [28 days]

   Assessed by ultrasound

2. Number of patients with asymptomatic VTE within 28 days after bariatric surgery [28 days]

   Assessed by ultrasound

3. All cause mortality within 28 days after bariatric surgery [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Baden	Baden		Switzerland
2	University Hospital, Inselspital Berne	Berne		Switzerland	3010
3	Clinic Beau-Site	Bern		Switzerland

Sponsors and Collaborators

• University Hospital Inselspital, Berne
• Bayer
• Janssen Pharmaceuticals

Investigators

• Principal Investigator: Guido Stirnimann, MD, Berne, University Hospital, University of Berne, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT03522259
• Other Study ID Numbers: UVCMBS003
• First Posted: May 11, 2018
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: Rivaroxaban; Thromboembolic prophylaxis; Venous thromboembolism
• Additional relevant MeSH terms: Venous Thromboembolism; Rivaroxaban

Study Results

No Results Posted as of May 18, 2022