Prospective randomized trial comparing efficacy and safety of intravenous and intra-articular tranexamic acid in total knee arthroplasty.

IF 4.1 Q1 ORTHOPEDICS Knee Surgery & Related Research Pub Date : 2020-11-18 DOI:10.1186/s43019-020-00079-8
Moses Man-Lung Li, Jojo Yan-Yan Kwok, Kwong-Yin Chung, Kin-Wing Cheung, Kwok-Hing Chiu, Wai-Wang Chau, Kevin Ki-Wai Ho
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引用次数: 6

Abstract

Background: Total knee arthroplasty (TKA) is associated with significant perioperative blood loss and postoperative allogenic blood transfusion. Tranexamic acid (TXA) reversibly blocks lysine binding sites on plasminogen molecules and inhibits plasmin formation. Comparisons of the efficacy and safety of intra-articular and intravenous TXA in primary TKA have not previously been reported.

Methods: A prospective randomized trial was conducted in 150 patients who underwent TKA, and these patients were randomized into three groups. Patients in Group A were injected by intra-articular TXA according to body weight (20 mg/kg). Patients in Group B received a standard dose of intra-articular TXA (2000 mg), and those in Group C were infused with TXA according to body weight (20 mg/kg) before tourniquet deflation and again 3 h later. Baseline characteristics and data collected at blood transfusion were compared. Differences among four time points (baseline, day 0, day 2, and day 5) were carried out using ANOVA.

Results: The hemoglobin levels at postoperative day 5 were 10.6 g/dL for Group A, 10.6 g/dL for Group B, and 10.7 g/dL for Group C. The drain output was 399 ml for Group A, 314 ml for Group B, and 305 ml for Group C (p = 0.03). Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C.

Conclusion: The weight-adjusted dose of TXA administered intravenously significantly reduced the drain output but not the total blood loss when compared with the weight-adjusted dose of TXA administered intra-articularly. No significant difference was observed in the other parameters among the three groups.

Trial registration: The Joint CUHK-NTEC CREC, CRE-2013.644-T . Registered 1 March 2014.

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前瞻性随机试验比较全膝关节置换术中静脉注射和关节内注射氨甲环酸的疗效和安全性。
背景:全膝关节置换术(TKA)与围手术期大量失血和术后同种异体输血相关。氨甲环酸(TXA)可逆阻断纤溶酶原分子上赖氨酸结合位点并抑制纤溶酶形成。关节内和静脉注射TXA治疗原发性TKA的疗效和安全性的比较以前没有报道。方法:对150例TKA患者进行前瞻性随机试验,将患者随机分为三组。A组患者按体重关节内注射TXA (20 mg/kg)。B组患者给予标准剂量关节内注射TXA (2000 mg), C组患者在止血带放气前按体重输注TXA (20 mg/kg), 3 h后再次输注。基线特征和输血时收集的数据进行比较。四个时间点(基线、第0天、第2天和第5天)的差异使用方差分析进行分析。结果:术后第5天血红蛋白水平A组为10.6 g/dL, B组为10.6 g/dL, C组为10.7 g/dL。引流液量A组为399 ml, B组为314 ml, C组为305 ml (p = 0.03)。经事后比较,C组的排血量明显低于A组(p = 0.05),而A组与B组、B组与C组的排血量差异无统计学意义(p = 0.09)。结论:与体重调整剂量的关节内给药相比,体重调整剂量的静脉给药可显著降低排血量,但对总失血量无统计学意义。三组间其他参数差异无统计学意义。试验注册:中国中文大学-新科大联合CREC, CRE-2013.644-T。注册于2014年3月1日。
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