Abstract
PurposeThe present study aimed to confirm the efficacy and safety of topical and intravenous tranexamic acid (TXA) compared with that of topical placebo and to assess the noninferiority between the two application methods of TXA in patients undergoing unilateral primary total hip arthroplasty.MethodsOur randomized controlled trial investigated 170 patients with 1:1:1 allocation to two doses of 10-mg/kg intravenous TXA, 3-g topical TXA, and topical placebo of 60-ml physiological saline groups. The primary outcome, total blood loss, was calculated with Nadler and Gross formula. The secondary outcomes included allogeneic blood transfusion requirement, drain blood loss, decreased hemoglobin level. Noninferiority would be established when the upper limit 95% CI is lower than 250 ml of the noninferiority margin for the mean difference of total blood loss between topical and intravenous TXA. Thromboembolic complication incidence was considered as a safety outcome.ResultsThe total blood loss of patients administered intravenous (mean±standard deviation, 1125±514 ml) and topical TXA (1211±425 ml) was significantly reduced compared with that of those administered topical placebo (1464±556 ml) (p = 0.0012). Drain blood loss and hemoglobin level reduction in patients administered with TXA were also significantly lower than those in patients administered topical placebo. The mean difference of total blood loss between topical and intravenous TXA is 86 ml (95% CI, −88 to 260 ml). The complications were comparable between patients managed with TXA and patients with topical placebo.ConclusionThe noninferiority of topical TXA to intravenous TXA can not be concluded. Considering no significant difference was found in all efficacy outcomes between the two administration methods. Any of the two TXA administration methods can be adopted for blood loss prevention in total hip arthroplasty.
Highlights
Hemorrhage and subsequent anemia are highly prevalent in patients undergoing total hip arthroplasty (THA) [1, 2].Postoperative anemia will impede physical functioning, delay rehabilitation, and increase mortality [3]
Drain blood loss and hemoglobin level reduction in patients administered with tranexamic acid (TXA) were significantly lower than those in patients administered topical placebo
The mean difference of total blood loss between topical and intravenous TXA is 86 ml
Summary
Hemorrhage and subsequent anemia are highly prevalent in patients undergoing total hip arthroplasty (THA) [1, 2]. Postoperative anemia will impede physical functioning, delay rehabilitation, and increase mortality [3]. Approximately one-thirds of the patients may require allogeneic blood transfusion. Allogeneic transfusion is associated with risks for disease transmission, immunosuppression, and transfusion reactions [4]. Postoperative anemia may impede the patients from physical recovery and increase the risk of postoperative infections. Tranexamic acid (TXA) was introduced as an alternative to reduce perioperative blood loss and allogeneic transfusion requirement [5,6,7]
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