BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 3
- 主要终点
- Number of patients with symptomatic or asymptomatic VTE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions
- •Written informed consent
排除标准
- •DVT and/or PE in the patient history
- •Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry
- •Uncontrolled hypertension
研究组 & 干预措施
A: Rivaroxaban short arm
7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
干预措施: Rivaroxaban 10 MG Oral Tablet [Xarelto] (Drug)
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
干预措施: Rivaroxaban 10 MG Oral Tablet [Xarelto] (Drug)
结局指标
主要结局
Number of patients with symptomatic or asymptomatic VTE
时间窗: 28 days
Assessed by ultrasound
次要结局
- Number of patients with symptomatic VTE within 28 days after bariatric surgery(28 days)
- Number of patients with asymptomatic VTE within 28 days after bariatric surgery(28 days)
- All cause mortality within 28 days after bariatric surgery(28 days)