Changde Wang1, Pengde Kang2, Jun Ma3, Chen Yue4, Jinwei Xie5, Fuxing Pei6. 1. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China; Department of Orthopedic Surgery, Affiliated Hospital, Northwest University for Nationalities, Lanzhou, Gansu Province 730030, China. Electronic address: wangchangde76@163.com. 2. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China. Electronic address: kangpd@163.com. 3. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China. Electronic address: 492385233@qq.com. 4. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China. Electronic address: 596681500@qq.com. 5. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China. Electronic address: 154762995@qq.com. 6. Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province 610041, China. Electronic address: pfxhuaxi@sina.com.
Abstract
BACKGROUND:Tranexamic acid can be effective at decreasing blood loss and transfusion requirements associated with total hip arthroplasty (THA), but few studies have compared the efficacy of different intravenous dosing regimes. This double-blind, randomized controlled trial compared the ability of two doses of intravenous TXA (IV-TXA, 10 or 15mg/kg) to reduce bleeding and transfusions associated with THA. MATERIALS AND METHODS: A total of 124 patients scheduled for THA were consecutively randomized 1:1:1 into three parallel arms: control (placebo), 10mg/kg IV-TXA and 15mg/kg IV-TXA. RESULTS: The proportion of patients who experienced bleeding and required transfusions was significantly lower in the 15mg/kg IV-TXA group (1 of 42, 2.4%) than in the 10mg/kg IV-TXA group (8 of 39, 20.5%; P=0.012) and in the control group (10 of 38, 26.3%; P=0.002). In fact, this proportion was similar between the 10mg/kg IV-TXA and control groups (P=0.547). Ultrasound examination on postoperative day 3 revealed only one case of asymptomatic deep vein thrombosis (in the femoral vein) in the 10mg/kg IV-TXA group, which was managed by administering low-molecular-weight heparin. No cases of deep-vein thrombosis were observed in the other two groups. No cases of symptomatic pulmonary embolism were observed. CONCLUSION:IV-TXA at 10mg/kg significantly reduced blood loss and mitigated the decrease in hemoglobin and hematocrit after THA, but it did not significantly reduce the need for transfusions. In contrast, a dose of 15mg/kg reduced both bleeding and transfusion requirements. Our results argue for a dose of 15mg/kg when using single-dose IV-TXA. LEVEL OF EVIDENCE: Therapeutic Level I.
RCT Entities:
BACKGROUND:Tranexamic acid can be effective at decreasing blood loss and transfusion requirements associated with total hip arthroplasty (THA), but few studies have compared the efficacy of different intravenous dosing regimes. This double-blind, randomized controlled trial compared the ability of two doses of intravenous TXA (IV-TXA, 10 or 15mg/kg) to reduce bleeding and transfusions associated with THA. MATERIALS AND METHODS: A total of 124 patients scheduled for THA were consecutively randomized 1:1:1 into three parallel arms: control (placebo), 10mg/kg IV-TXA and 15mg/kg IV-TXA. RESULTS: The proportion of patients who experienced bleeding and required transfusions was significantly lower in the 15mg/kg IV-TXA group (1 of 42, 2.4%) than in the 10mg/kg IV-TXA group (8 of 39, 20.5%; P=0.012) and in the control group (10 of 38, 26.3%; P=0.002). In fact, this proportion was similar between the 10mg/kg IV-TXA and control groups (P=0.547). Ultrasound examination on postoperative day 3 revealed only one case of asymptomatic deep vein thrombosis (in the femoral vein) in the 10mg/kg IV-TXA group, which was managed by administering low-molecular-weight heparin. No cases of deep-vein thrombosis were observed in the other two groups. No cases of symptomatic pulmonary embolism were observed. CONCLUSION:IV-TXA at 10mg/kg significantly reduced blood loss and mitigated the decrease in hemoglobin and hematocrit after THA, but it did not significantly reduce the need for transfusions. In contrast, a dose of 15mg/kg reduced both bleeding and transfusion requirements. Our results argue for a dose of 15mg/kg when using single-dose IV-TXA. LEVEL OF EVIDENCE: Therapeutic Level I.