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Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery (BARIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522259
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : October 30, 2019
Sponsor:
Collaborators:
Bayer
Janssen Pharmaceuticals
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto] Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Active Comparator: A: Rivaroxaban short arm
7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
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)

Active Comparator: B: Rivaroxaban long arm

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

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)




Primary Outcome Measures :
  1. Number of patients with symptomatic or asymptomatic VTE [ Time Frame: 28 days ]
    Assessed by ultrasound


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522259


Contacts
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Contact: Guido Stirnimann, MD +41 31 632 21 11 ext +41316322111 guido.stirnimann@insel.ch

Locations
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Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland
Contact: Antonio Nocito    +41564863002    antonio.nocito@ksb.ch   
University Hospital, Inselspital Berne Recruiting
Berne, Switzerland, 3010
Contact: Guido Stirnimann, MD    +41316322111    guido.stirnimann@insel.ch   
Clinic Beau-Site Recruiting
Bern, Switzerland
Contact: Joerg Zehetner    +41313126112    joerg.zehetner@hirslanden.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Bayer
Janssen Pharmaceuticals
Investigators
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Principal Investigator: Guido Stirnimann, MD Berne, University Hospital, University of Berne, Switzerland
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03522259    
Other Study ID Numbers: UVCMBS003
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Rivaroxaban
Thromboembolic prophylaxis
Venous thromboembolism
Additional relevant MeSH terms:
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Venous Thromboembolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants