Clinical trial NCT03522259: Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery
Official title: BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bariatric Surgery
Keywords: Rivaroxaban
Thromboembolic prophylaxis
Venous thromboembolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Bayer
name: Janssen Pharmaceuticals
First posted: 2018-05-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of patients with symptomatic or asymptomatic VTE
timeFrame: 28 days
Secondary outcomes:
measure: Number of patients with symptomatic VTE within 28 days after bariatric surgery
timeFrame: 28 days
measure: Number of patients with asymptomatic VTE within 28 days after bariatric surgery
timeFrame: 28 days
measure: All cause mortality within 28 days after bariatric surgery
timeFrame: 28 days
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Berne
country: Switzerland
facility: University Hospital, Inselspital Berne
city: Bern
country: Switzerland
facility: Clinic Beau-Site
Study officials:
affiliation: Berne, University Hospital, University of Berne, Switzerland
name: Guido Stirnimann, MD
role: PRINCIPAL_INVESTIGATOR
References: