HaiYan Zhao1,2, MaoYing Xiang1, YaYi Xia2, Xiaojun Shi1, Fu-Xing Pei1, PengDe Kang3. 1. Department of Orthopedics, West China Hospital, West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, 610041, People's Republic of China. 2. Department of Orthopedics, Lanzhou University Second Hospital, Lanzhou, People's Republic of China. 3. Department of Orthopedics, West China Hospital, West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, 610041, People's Republic of China. kangpd@163.com.
Abstract
BACKGROUND:Tranexamic acid (TXA), delivered intravenously or topically, has been shown to reduce blood loss, the need for transfusion, and relevant healthcare costs when administered in primary standard total hip arthroplasty (THA). Whether the same is true of oral TXA is unclear, the purpose of this study was to determine if oral tranexamic acid is equivalent to intravenous TXA in the case of patients undergoing THA via the direct anterior approach. METHODS: In this prospective randomized controlled trial, 120 patients undergoing primary THA by the direct anterior approach were randomized to receive oral TXA (two doses of 20 mg/kg), intravenous TXA (two doses of 15 mg/kg), or no TXA. Primary outcomes were haemoglobin drop, haematocrit levels, total blood loss, intra-operative blood loss, need for transfusion, and volume transfused. Secondary outcomes included thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission. RESULTS:Demographic characteristics were similar among the three patient groups (p > 0.05, n = 40 per group). Haemoglobin drop, haematocrit levels, total blood loss, and intra-operative blood loss were similar in the oral and intravenous groups (p > 0.05), and significantly smaller than in the control group (p < 0.05). Transfusions were given to significantly fewer patients in the oral group (3%) and intravenous group (6%) than in the control group (27%, p = 0.01). Costs of TXA and transfusions were significantly lower in the oral group than the intravenous group (p < 0.05). The three groups were similar in thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission (p > 0.05). CONCLUSION:Oral TXA shows similar efficacy and safety as intravenous TXA for reducing haemoglobin drop, haematocrit levels, total blood loss, and transfusion rate following THA by the direct anterior approach. Therefore, the much less-expensive oral formulation may be superior to the intravenous form.
RCT Entities:
BACKGROUND:Tranexamic acid (TXA), delivered intravenously or topically, has been shown to reduce blood loss, the need for transfusion, and relevant healthcare costs when administered in primary standard total hip arthroplasty (THA). Whether the same is true of oral TXA is unclear, the purpose of this study was to determine if oral tranexamic acid is equivalent to intravenous TXA in the case of patients undergoing THA via the direct anterior approach. METHODS: In this prospective randomized controlled trial, 120 patients undergoing primary THA by the direct anterior approach were randomized to receive oral TXA (two doses of 20 mg/kg), intravenous TXA (two doses of 15 mg/kg), or no TXA. Primary outcomes were haemoglobin drop, haematocrit levels, total blood loss, intra-operative blood loss, need for transfusion, and volume transfused. Secondary outcomes included thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission. RESULTS: Demographic characteristics were similar among the three patient groups (p > 0.05, n = 40 per group). Haemoglobin drop, haematocrit levels, total blood loss, and intra-operative blood loss were similar in the oral and intravenous groups (p > 0.05), and significantly smaller than in the control group (p < 0.05). Transfusions were given to significantly fewer patients in the oral group (3%) and intravenous group (6%) than in the control group (27%, p = 0.01). Costs of TXA and transfusions were significantly lower in the oral group than the intravenous group (p < 0.05). The three groups were similar in thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission (p > 0.05). CONCLUSION: Oral TXA shows similar efficacy and safety as intravenous TXA for reducing haemoglobin drop, haematocrit levels, total blood loss, and transfusion rate following THA by the direct anterior approach. Therefore, the much less-expensive oral formulation may be superior to the intravenous form.
Entities:
Keywords:
Blood loss; Direct anterior approach; Oral administration; Total hip arthroplasty; Tranexamic acid
Authors: Blake P Gillette; Hilal Maradit Kremers; Christopher M Duncan; Hugh M Smith; Robert T Trousdale; Mark W Pagnano; Rafael J Sierra Journal: J Arthroplasty Date: 2013-07-23 Impact factor: 4.757