Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The volume of postoperative blood loss in the drain
研究概览
简要总结
This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.
详细描述
Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with osteoarthritis in need of a TKA
排除标准
- •inflammatory arthritis
- •post-traumatic arthritis
- •a history of or current venous thromboembolic disease
- •any underlying disease of haemostasis
- •cirrhosis
- •chronic renal failure
- •patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
- •know allergy to TXA
- •defective color vision
- •preoperative hemoglobin <10 g/dL
- •platelet count < 140,000 /uL3
研究组 & 干预措施
Peri-articular group
Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure.
干预措施: Peri-articular tranexamic acid (Drug)
Intravenous group
Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure.
干预措施: Intravenous tranexamic acid (Drug)
结局指标
主要结局
The volume of postoperative blood loss in the drain
时间窗: 48 hours after the operation
Changes from baseline hemoglobin concentrations
时间窗: 48 hours after the operation
unit of blood transfusion
时间窗: 48 hours after the operation
次要结局
- Knee diameter for swelling(At 24 and 48 hours after the operation)
- number of patient with venous thromboembolism(At 14 days after the operation)
研究者
piya pinsornsak
Dr.
Thammasat University