Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

Phase 2

Completed

• Conditions: Bariatric Surgery
• Interventions: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

• Registration Number: NCT03522259
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Study Start: 2018-07-19
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Rivaroxaban short arm	Rivaroxaban 10 MG Oral Tablet [Xarelto]	7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
B: Rivaroxaban long arm	Rivaroxaban 10 MG Oral Tablet [Xarelto]	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

Primary Outcome Measures

Name	Time	Method
Number of patients with symptomatic or asymptomatic VTE	28 days	Assessed by ultrasound

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

University Hospital, Inselspital Berne; 🇨🇭 Berne, Switzerland

Clinic Beau-Site; 🇨🇭 Bern, Switzerland