Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery

Abstract

Background: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. Evidence supporting its efficacy in surgery for adolescent idiopathic scoliosis is not robust. This trial was designed to validate the clinical efficacy of TXA in surgery for adolescent idiopathic scoliosis. Methods: This institutional review board-approved prospective double-blinded trial involved 111 patients with adolescent idiopathic scoliosis who were randomized to receive either a placebo or TXA (50-mg/kg loading dose and 10-mg/kg/h infusion). Power analysis indicated that 50 patients per group would provide power to detect a >20% difference in blood loss. Two-way analysis of variance (ANOVA) was applied to compare blood loss rates (slopes) using the group-by-time interaction F test. Results: The risk of clinically relevant blood loss (>20 mL/kg) was more than twice as high in the placebo group than in the TXA group (44% versus 21%, relative risk = 2.1, 95% confidence interval = 1.2 to 3.7). Compared with the placebo group, the TXA group had a 27% reduction in intraoperative blood loss, a significantly lower rate of intraoperative bleeding per hour (mean and standard deviation, 190 ± 73 versus 230 ± 80 mL, p = 0.01; F = 9.77, p < 0.001) and per fused spinal level (82 ± 32 versus 110 ± 40 mL, p < 0.001), less intraoperative blood loss (836 ± 373 versus 1,031 ± 484 mL, p = 0.02), and less postoperative bleeding (in the drain) (498 ± 228 versus 645 ± 318 mL, p = 0.009). Six patients who received a placebo and no patient who received TXA required an allogenic blood transfusion. No perioperative adverse events, including thromboembolic events or seizures, were observed. Three independent factors were predictive of blood loss: TXA administration, duration of surgery, and number of levels fused. Greater intraoperative blood loss was the only independent variable predictive of a longer hospital stay. Conclusions: Use of TXA in patients undergoing surgery for adolescent idiopathic scoliosis significantly reduced blood loss, by 27%, compared with that in the placebo group. The rate of intraoperative blood loss per hour and per level fused and the amount of postoperative blood loss were significantly lower in the TXA group. More placebo-treated patients received allogenic blood. Patients with greater intraoperative blood loss spent a longer time in the hospital. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Vertebra Cerrahisinde İntraoperatif Yüksek Doz Traneksamik Asit İnfüzyonu: Klinik Deneyimlerimiz

“…18 In a study in which intraoperative TXA was used at a loading dose of 50 mg/kg and infusion dose of 10 mg/kg/h in adolescent idiopathic scoliosis patients, it was reported that intraoperative blood loss decreased by 27% compared with that in the placebo group and that none of the patients developed postoperative complications such as thromboembolic events or clinical seizures. 9 In another study, TXA was reported to reduce intraoperative blood loss when administered at a loading dose of 100 mg/kg and infusion dose of 10 mg/kg; furthermore, no negative side effects were observed. 8 The administration dose of TXA varies between 10 and 100 mg/kg for loading dose and between 1 and 10 mg/kg/h for continuous infusion dose.…”

“…11 Goobie et al reported that the blood loss amount per hour was 190 ± 73 ml/h in the TXA group and 230 ± 80 ml/h in the placebo group in the intraoperative period in adolescent idiopathic scoliosis patients. 9 They used the TXA at a loading dose of 50 mg/kg and a maintenance dose of 10 mg/kg/hour. Lykissas et al reported that the mean intraoperative blood loss was significantly lower in the receiving high doses (100 mg/kg bolus dose and infusion dose of 10 mg/kg) TXA (537 ml) than in the placebo group (1245 ml).…”

“…8 TXA is used in a wide dose range in patients of different ages undergoing a variety of surgical procedures. 9 Even though antifibrinolytic agents are typically considered safe, they may be associated with side effects such as thrombotic events and seizures. Appropriate dosages to maximise effect and minimise risk remains not to be fully established.…”

“…Appropriate dosages to maximise effect and minimise risk remains not to be fully established. 9,10 In this retrospective study, we aimed to evaluate the amount of blood loss, need of transfusion and postoperative side effects in the patients who underwent vertebral surgery due to deformities such as scoliosis, kyphosis or kyphoscoliosis and received high doses of TXA intraoperatively.…”

Safe and Effective Performance of Pediatric Spinal Deformity Surgery in Patients Unwilling to Accept Blood Transfusion: A Clinical Study and Review of Literature

“…In a study by Grant et al on the comparative e cacy of high-dose TXA (20mg/kg loading, 10mg/kg/hr maintenance) vs. low-dose TXA (10mg/kg loading, 1mg/kg/hr maintenance), the authors reported that high-dose TXA showed a trend toward a reduction in transfusion requirements compared to low-dose TXA [43]. Based on the above data, literature from adult populations, and our own clinical experience, we use a loading dose of 50mg/kg and a maintenance dose of 5mg/kg/hr [44]. Analogous to systemic TXA, topical TXA has been used in various surgical specialties to decrease perioperative blood loss.…”