Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery (BARIVA)

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 2

Conditions: Bariatric Surgery

Treatments: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03522259

UVCMBS003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

A: Rivaroxaban short arm

Active Comparator group

Description:

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

Treatment:

Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

B: Rivaroxaban long arm

Active Comparator group

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

Treatment:

Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]