The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Changes from baseline hemoglobin concentrations
研究概览
简要总结
Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.
详细描述
Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 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)
- •Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
- •Allergy to TXA
研究组 & 干预措施
Peri-articular tranexamic acid injection
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
干预措施: Peri-articular TXA (15 mg/kg) (Drug)
Peri-articular tranexamic acid injection
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
干预措施: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Procedure)
Intraarticular tranexamic acid injection
TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
干预措施: Intraarticular TXA 2 g (40 mL) (Drug)
Intraarticular tranexamic acid injection
TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
干预措施: TXA 40 mL inject into intraaricular knee capsule (Procedure)
结局指标
主要结局
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
- Tranexamic acid level in blood(2 and 24 hours after the operation)
- Knee diameter for swelling(24 and 48 hours after the operation)
- Local soft tissue complications(14 days after the operation)
- Skin necrosis(24 and 48 hours after the operation)
- Number of patient with venous thromboembolism(14 days after the operation)
- Visual Analogue Scales(24 and 48 hours after the operation)
- Knee flexion angle(24 and 48 hours after the operation)
研究者
piya pinsornsak
Principal Investigator
Thammasat University