BACKGROUND:Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss and the need for transfusions when administered intravenously in total hip arthroplasty. Oral formulations of the drug are available at a fraction of the cost of the intravenous preparation. The purpose of this randomized controlled trial was to determine if oral and intravenous formulations of tranexamic acid have equivalent blood-sparing properties. METHODS: In this double-blinded trial, 89 patients undergoing primary total hip arthroplasty were randomized to receive 1.95 g of tranexamic acid orally 2 hours preoperatively or a 1-g tranexamic acid intravenous bolus in the operating room prior to incision; 6 patients were eventually excluded for protocol deviations, leaving 83 patients available for study. The primary outcome was the reduction of hemoglobin concentration. Power analysis determined that 28 patients were required in each group with a ±1.0 g/dL hemoglobin equivalence margin between groups with an alpha of 5% and a power of 80%. Equivalence analysis was performed with a two one-sided test (TOST) in which a p value of <0.05 indicated equivalence between treatments. RESULTS: Forty-three patients received intravenous tranexamic acid, and 40 patients received oral tranexamic acid. Patient demographic characteristics were similar between groups, suggesting successful randomization. The mean reduction of hemoglobin was similar between oral and intravenous groups (3.67 g/dL compared with 3.53 g/dL; p = 0.0008, equivalence). Similarly, the mean total blood loss was equivalent between oral and intravenous administration (1,339 mL compared with 1,301 mL; p = 0.034, equivalence). Three patients (7.5%) in the oral group and one patient (2.3%) in the intravenous group were transfused, but the difference was not significant (p = 0.35). None of the patients in either group experienced a thromboembolic event. CONCLUSIONS:Oral tranexamic acid provides equivalent reductions in blood loss in the setting of primary total hip arthroplasty, at a greatly reduced cost, compared with the intravenous formulation. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND:Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss and the need for transfusions when administered intravenously in total hip arthroplasty. Oral formulations of the drug are available at a fraction of the cost of the intravenous preparation. The purpose of this randomized controlled trial was to determine if oral and intravenous formulations of tranexamic acid have equivalent blood-sparing properties. METHODS: In this double-blinded trial, 89 patients undergoing primary total hip arthroplasty were randomized to receive 1.95 g of tranexamic acid orally 2 hours preoperatively or a 1-g tranexamic acid intravenous bolus in the operating room prior to incision; 6 patients were eventually excluded for protocol deviations, leaving 83 patients available for study. The primary outcome was the reduction of hemoglobin concentration. Power analysis determined that 28 patients were required in each group with a ±1.0 g/dL hemoglobin equivalence margin between groups with an alpha of 5% and a power of 80%. Equivalence analysis was performed with a two one-sided test (TOST) in which a p value of <0.05 indicated equivalence between treatments. RESULTS: Forty-three patients received intravenous tranexamic acid, and 40 patients received oral tranexamic acid. Patient demographic characteristics were similar between groups, suggesting successful randomization. The mean reduction of hemoglobin was similar between oral and intravenous groups (3.67 g/dL compared with 3.53 g/dL; p = 0.0008, equivalence). Similarly, the mean total blood loss was equivalent between oral and intravenous administration (1,339 mL compared with 1,301 mL; p = 0.034, equivalence). Three patients (7.5%) in the oral group and one patient (2.3%) in the intravenous group were transfused, but the difference was not significant (p = 0.35). None of the patients in either group experienced a thromboembolic event. CONCLUSIONS: Oral tranexamic acid provides equivalent reductions in blood loss in the setting of primary total hip arthroplasty, at a greatly reduced cost, compared with the intravenous formulation. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Authors: Shane A Sobrio; Angeline Johny; Alex Gu; Chapman Wei; Christopher Jones; Jordan S Cohen; Jiabin Liu; Peter K Sculco Journal: J Orthop Date: 2019-02-28
Authors: Sara Juliana de A de Vasconcellos; Edmundo M do Nascimento-Júnior; Marcel Vinícius de Aguiar Menezes; Mário Luis Tavares Mendes; Rafael de Souza Dantas; Paulo Ricardo Saquete Martins-Filho Journal: JAMA Otolaryngol Head Neck Surg Date: 2018-09-01 Impact factor: 6.223
Authors: Nicholas P Drain; Valerie C Gobao; Dominique M Bertolini; Clair Smith; Neel B Shah; Scott D Rothenberger; Malcolm E Dombrowski; Michael J O'Malley; Brian A Klatt; Brian R Hamlin; Kenneth L Urish Journal: J Arthroplasty Date: 2020-03-04 Impact factor: 4.757