Zeng Yi1, Shen Bin2, Yang Jing3, Zhou Zongke3, Kang Pengde3, Pei Fuxing3. 1. Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, People's Republic of China zengyigd@126.com. 2. Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, People's Republic of China shenbin_1971@163.com. 3. Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
Abstract
BACKGROUND: The use of tranexamic acid (TXA) in primary total hip arthroplasty is well documented. However, considering the potential side effects, including deep vein thrombosis and pulmonary embolism, the ideal method of providing TXA to patients undergoing total hip arthroplasty remains controversial. The objective of this trial was to assess the efficacy and safety of intravenous (IV) administration combined with topical administration of TXA regarding postoperative blood loss and transfusion rates in patients treated with primary unilateral total hip arthroplasty. METHODS: In this prospective, randomized controlled trial, 150 patients were divided into three groups: the combined group (IV administration of 15 mg/kg of TXA combined with topical administration of 1 g/100 mL of TXA), the single IV group (IV administration of 15 mg/kg of TXA), and the placebo group. The primary outcomes included blood-loss variables (total, intraoperative, and drainage blood loss; changes in hemoglobin, hematocrit, and platelet concentration; and amount of IV transfusion fluid) and transfusion values (frequency of transfusion and number of transfused blood units). The secondary outcomes included the length of the hospital stay, range of hip motion, Harris hip score, and prevalences of deep vein thrombosis and pulmonary embolism. RESULTS: The total blood loss in the combined group (mean and standard deviation, 835.49 ± 343.50 mL) was significantly reduced (p < 0.05) in comparison with that in the single IV group (1002.62 ± 366.85 mL) and placebo group (1221.11 ± 386.25 mL). The combined group also had fewer transfusions in comparison with the single IV and placebo groups (1, 8, and 19, respectively; p < 0.05). There was no difference among the 3 groups with regard to the rates of deep vein thrombosis or pulmonary embolism. CONCLUSIONS:Intravenous combined with topical administration of TXA in patients undergoing a primary unilateral total hip arthroplasty significantly reduced postoperative bleeding and the transfusion rate. Studies with more patients and longer follow-up are needed to confirm whether this promising combined strategy is safe with regard to thromboembolic complications. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND: The use of tranexamic acid (TXA) in primary total hip arthroplasty is well documented. However, considering the potential side effects, including deep vein thrombosis and pulmonary embolism, the ideal method of providing TXA to patients undergoing total hip arthroplasty remains controversial. The objective of this trial was to assess the efficacy and safety of intravenous (IV) administration combined with topical administration of TXA regarding postoperative blood loss and transfusion rates in patients treated with primary unilateral total hip arthroplasty. METHODS: In this prospective, randomized controlled trial, 150 patients were divided into three groups: the combined group (IV administration of 15 mg/kg of TXA combined with topical administration of 1 g/100 mL of TXA), the single IV group (IV administration of 15 mg/kg of TXA), and the placebo group. The primary outcomes included blood-loss variables (total, intraoperative, and drainage blood loss; changes in hemoglobin, hematocrit, and platelet concentration; and amount of IV transfusion fluid) and transfusion values (frequency of transfusion and number of transfused blood units). The secondary outcomes included the length of the hospital stay, range of hip motion, Harris hip score, and prevalences of deep vein thrombosis and pulmonary embolism. RESULTS: The total blood loss in the combined group (mean and standard deviation, 835.49 ± 343.50 mL) was significantly reduced (p < 0.05) in comparison with that in the single IV group (1002.62 ± 366.85 mL) and placebo group (1221.11 ± 386.25 mL). The combined group also had fewer transfusions in comparison with the single IV and placebo groups (1, 8, and 19, respectively; p < 0.05). There was no difference among the 3 groups with regard to the rates of deep vein thrombosis or pulmonary embolism. CONCLUSIONS: Intravenous combined with topical administration of TXA in patients undergoing a primary unilateral total hip arthroplasty significantly reduced postoperative bleeding and the transfusion rate. Studies with more patients and longer follow-up are needed to confirm whether this promising combined strategy is safe with regard to thromboembolic complications. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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