Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

Bariatric Surgery Clinical Trial

— BARIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522259
• Other study ID #: UVCMBS003
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Venous Thromboembolism

Intervention

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)

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden
Switzerland	Clinic Beau-Site	Bern
Switzerland	University Hospital, Inselspital Berne	Berne

Sponsors (3)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Bayer, Janssen Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

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