Selective Thromboembolism Prophylaxis After Total Hip Arthroplasty or Total Knee Arthroplasty by a Risk Stratification With Thromboelastography for Asian Populations: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 主要终点
- The Incidence of Deep Vein Thrombosis
研究概览
简要总结
Asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for Caucasian populations may be too excessive for Asians. So, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for Asians.The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty for Asian populations.
详细描述
Asian patients who underwent hip or knee arthroplasty in Guangdong General Hospital from August 2016 to August 2017 were randomly divided into selective anticoagulation group (SAG) and conventional anticoagulation group (CAG). SAG used anticoagulant when TEG indicated hypercoagulability while CAP used anticoagulant until one month after surgery regularly. Data including patients' basic information, postoperative complications, perioperative clotting index, intraoperative blood loss, perioperative TEG, volume of drainage, and blood transfusion were evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age,
- •ASA Ⅰ-Ⅱ grade,
- •BMI <40Kg / M ^ 2
- •Underwent total knee arthroplasty/ total hip arthroplasty in Guangdong General Hospital
- •consent to enroll in this study
排除标准
- •history of VTE, preoperative infection, preoperative coagulation
- •liver and kidney function existed clinically abnormalities
- •history of tumor
- •history of vascular surgery
- •heart infarction or cerebral infarction within 6 months
- •history of lower extremity surgery within 3 months
研究组 & 干预措施
selective anticoagulation group
Selective anticoagulation group used anticoagulant when thromboelastogram（TEG） indicated hypercoagulability.
TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery.
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
干预措施: selective anticoagulation (Drug)
conventional anticoagulation group
The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely.
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
干预措施: selective anticoagulation (Drug)
结局指标
主要结局
The Incidence of Deep Vein Thrombosis
时间窗: 6 months after surgery
Measured by ultrasound
次要结局
- Hematocrit(5 days after surgery)
- Hemoglobin(5 days after surgery)
- Red Blood Cell(5 days after surgery)
- Volume of Transfusion(During Hospitalization)
- Transfusion Rate(During Hospitalization)
- Ecchymosis incidence Rate(1 month after surgery)
- Superficial Infection(6 months after surgery)
- Deep Infection(6 months after surgery)