Background: Extensive blood loss is common in pediatric craniosynostosis reconstruction surgery. Tranexamic acid (TXA) is increasingly used to reduce perioperative blood loss in various settings, but data on its efficacy are limited in children. The purpose of this randomized, double-blind, placebo-controlled, parallel trial was to evaluate the efficacy of TXA in pediatric craniosynostosis correction surgery. The primary and secondary outcome variables were reduction in perioperative blood loss and reduction in blood transfusion, respectively. Methods: Forty-three children, ages 2 months to 6 yr, received either placebo or TXA in a loading dose of 50 mg·kg(-1), followed by an infusion of 5 mg·kg·h(-1) during surgery. TXA plasma concentrations were measured. Results: The TXA group had significantly lower perioperative mean blood loss (65 vs. 119 ml·kg(-1), P < 0.001) and lower perioperative mean blood transfusion (33 vs. 56 ml· kg(-1), P = 0.006) compared to the placebo group. The mean difference between the TXA and placebo groups for total blood loss was 54 ml·kg(-1) (95% CI for the difference, 23-84 ml·kg(-1)) and for packed erythrocytes transfused was 23 ml·kg(-1) (95% CI for the difference, 7-39 ml·kg(-1)). TXA administration also significantly diminished (by two thirds) the perioperative exposure of patients to transfused blood (median, 1 unit vs. 3 units; P < 0.001). TXA plasma concentrations were maintained above the in vitro thresholds reported for inhibition of fibrinolysis (10 μg·ml(-1)) and plasmin-induced platelet activation (16 μg·ml(-1)) throughout the infusion. Conclusions: TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.

Summary: Patient Blood Management is the timely application of evidence‐based medical and surgical concepts designed to maintain hemoglobin concentration, optimize hemostasis, and minimize blood loss to improve patient outcomes. Conceptually similar to a “bundle” strategy, it is designed to improve clinical care using comprehensive evidence‐based treatment strategies to manage patients with potential or ongoing critical bleeding, bleeding diathesis, critical anemia, and/ or a coagulopathy. Patient Blood Management includes multimodal strategies to screen, diagnose and properly treat anemia, coagulopathies and minimize bleeding, using goal‐directed therapy and leverages a patient's physiologic ability to adapt to anemia while definitive treatment is undertaken. Allogeneic blood component transfusion is one traditional therapeutic modality out of many for managing blood loss and anemia and, while it may be the best choice in certain situations, other effective and more appropriate options are available and should be used in conjunction or alone. Therefore, comprehensive Patient Blood Management is the new standard of care to prevent and manage anemia and optimize hemostasis and has been recommended by the World Health Organization, the American Society of Anesthesiologists, the European Society of Anaesthesiology and the Australian National Blood Authority. While there is a plethora of expert consensus and good practice guidelines published for blood component transfusion from multiple professional organizations and societies, there remains a need for more comprehensive and broader standards of patient medical management to proactively reduce the risk of exposure to allogeneic transfusions. In 2010, the Society for Advancement of Blood Management published the first comprehensive standards to address the administrative and clinical components of an effective, patient‐centered Patient Blood Management program. Recognizing the need to reduce inappropriate transfusions, some professional organizations have placed their emphasis on transfusion guidelines. In contrast, the focus of the Society for Advancement of Blood Management Standard is on the centrality of the patient and the full spectrum of therapeutic strategies needed to improve clinical outcomes in patients at risk for blood loss or anemia, thereby reducing avoidable transfusions as well. The Standards are meant not to replace, but to complement transfusion guidelines by more completely addressing the need for a multi‐modal clinical approach with the goal to improve patient outcomes. Compared to adult programs, Pediatric Patient Blood Management programs are currently not commonly accepted as standard of care for pediatric patients. This is partly due to the fact that, until recently, there was a paucity of robust evidence‐based literature and expert consensus guidelines on pediatric PBM. Managing pediatric bleeding and blood product transfusion presents a unique set of challenges. The main goal of transfusion is to correct or avoid imminent inadequate oxygen carrying capacity caused by inadequate red blood cell mass. Determining when, what, and how much to transfuse can be difficult. Neonates, infants, children, and adolescents each have specific considerations based on age, weight, physiology, and pharmacology. In this edition of Pediatric Anaesthesia we provide, in abbreviated format, the 4th edition of the Administrative and Clinical Standards for Patient Blood Management; Pediatric Version, first published in 2010 with the addition of a new Pediatric section in 2016. These Standards provide guidance for implementing a comprehensive Pediatric Patient Blood Management program at both pediatric and adult medical institutions. While every hospital may not be equipped to have a dedicated Pediatric Patient Blood Management program, this document highlights important universal clinical strategies that can be implemented to optimize pediatric bleeding management and minimize allogeneic blood product exposure through the use of multi‐modal therapeutic strategies that have their central emphasis on the patient rather than the transfusion. Important strategies include: treatment of preoperative anemia, standardized transfusion algorithms, the use of restrictive transfusion thresholds, goal‐directed therapy based on point of care and viscoelastic testing, antifibrinolytics, and avoidance of hemodilution and hypothermia as supported by evidence. For the full version, please go to https://www.sabm.org/publications.

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.

Neonates have a high incidence of perioperative mortality worldwide.^1-5 In a 2015 study, the incidences of 24-hour and 30-day mortality in children were 13.3 per 10 000 operations and 41.6 per 10 000 operations, respectively, while a higher 30-day postoperative mortality rate of 386.5 per 10 000 was reported in the neonatal population.² In another study, postoperative 24-hour and 30-day mortality in children were reported as 0.98 deaths per 10 000 operations while both the 24-hour (168.7 deaths per 10 000 operations) and 30-day (350.4 deaths per 10 000 operations) mortality was substantially higher in neonates.¹ To our knowledge, incidence of postoperative neonatal mortality in US hospitals has never been reported.