Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Deep vein thrombosis
研究概览
简要总结
Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.
详细描述
This parallel study is conducted in a single hospital. The participants are divided into two groups. One group is provided with Xarelto, and the other one group is provided without any prophylactic antithrombotic. To check the presence of a deep vein thrombosis of the lower limb, bilateral sonographic examinations are arranged for all participants preoperatively and at 3 and 14 days postoperatively. One radiologists who was blinded to the nature of the study interpreted the results of the sonographic examination. The present of pulmonary embolism, DVT-related symptoms, and complications are recorded during the 3-months follow-up in orthopedics outpatients. The symptom which associated with DVT is defined as the signs of leg such as unusual pain, edema, swelling, warm skin, and red or discolored skin. Complications related to Xarelto include major bleeding, infection, and non-healing wound. The expected number of participants in each group is 89, which is calculated by G * Power version 3.1. The intention to treat analysis is used in this study. The investigators compare the incidences of DVT, pulmonary embolism, and complications between the two groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergo total knee replacement or total hip replacement
排除标准
- •Recent antithrombotics use
- •A history of a coagulopathy
- •Recent thromboembolic disease
- •Preoperative deep vein thrombosis screening presents positive
- •Age below 20
研究组 & 干预措施
Control
The participants are provided without antithrombotics
Rivaroxaban
The participants are provided with Rivaroxaban 10mg
干预措施: Rivaroxaban 10 MG (Drug)
结局指标
主要结局
Deep vein thrombosis
时间窗: Up to 3 months after THR and TKR
The incidence of both asymptomatic and symptomatic deep vein thrombosis
Pulmonary embolism
时间窗: Up to 3 months after THR and TKR
The incidence of pulmonary embolism
Deep Vein Thrombosis
时间窗: Up to 3 months after THR and TKR
The incidence of both asymptomatic and symptomatic deep vein thrombosis
Pulmonary Embolism
时间窗: Up to 3 months after THR and TKR
The incidence of pulmonary embolism
次要结局
- Complication(Up to 3 months after THR and TKR)
