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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| Janssen Pharmaceuticals | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Rivaroxaban short arm | Active Comparator | 7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. |
|
| B: Rivaroxaban long arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with symptomatic or asymptomatic VTE | Assessed by ultrasound | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with symptomatic VTE within 28 days after bariatric surgery | Assessed by ultrasound | 28 days |
| Number of patients with asymptomatic VTE within 28 days after bariatric surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Stirnimann, MD | Berne, University Hospital, University of Berne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Baden | Switzerland | ||||
| University Hospital, Inselspital Berne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37227726 | Derived | Kroll D, Nett PC, Rommers N, Borbely Y, Deichsel F, Nocito A, Zehetner J, Kessler U, Fringeli Y, Alberio L, Candinas D, Stirnimann G. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315241. doi: 10.1001/jamanetworkopen.2023.15241. | |
| 36413425 |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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Assessed by ultrasound
| 28 days |
| All cause mortality within 28 days after bariatric surgery | 28 days |
| Bern |
| 3010 |
| Switzerland |
| Clinic Beau-Site | Bern | Switzerland |
| Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2. |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |