The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Average amounts of transfusion
研究概览
简要总结
We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.
详细描述
A randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who plan to undergo primary total knee arthroplasty on unilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
- •All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
- •The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution
排除标准
- •Allergy to tranexamic acid;
- •Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
- •Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
- •Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
- •Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products;
- •Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).
研究组 & 干预措施
Tranexamic acid, IA group
Tranexamic acid 1g, intra-articular injection, post-operationally
干预措施: Tranexamic acid (Drug)
Tranexamic acid, IV group
Tranexamic acid, 1g, intravenous injection, post-operationally
干预措施: Tranexamic acid (Drug)
Tranexamic acid, IV+IA group
Tranexamic acid, 1g, intravenous injection, post-operationally; Tranexamic acid, 1g, intra-articular injection, post-operationally
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Average amounts of transfusion
时间窗: one week after surgery
次要结局
- Calculated blood loss(one week after surgery)
- thrombosis(3 months after surgery)
研究者
Chenxiaoyong
Doctor-in-charge
Xijing Hospital