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NCT Number: NCT03522259

Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kantonsspital Baden, Baden, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban 10 MG Oral Tablet [Xarelto]

Drug

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)

Primary outcomes

  1. Number of patients with symptomatic or asymptomatic VTE

    Time frame: 28 days

    Assessed by ultrasound

Secondary outcomes

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

    Time frame: 28 days

    Assessed by ultrasound

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

    Time frame: 28 days

    Assessed by ultrasound

  3. All cause mortality within 28 days after bariatric surgery

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Bayer
  • Janssen Pharmaceuticals

Registry information

Official study title

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

Acronym: BARIVA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 11, 2018
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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