1.
Tranexamic Acid in Hip Reconstructions in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Clinical Trial
Zuccon, A., Rogério Cardozo Kanaji, P., Serafini Barcellos, D., Zabulon, S., de Oliveira Saraiva, A., Yoshi de Freitas, T. A.
Children (Basel, Switzerland). 2023;10(12)
Abstract
Surgical treatment is indicated for hip dislocation in patients with cerebral palsy (CP), but it requires care due to the state of nutrition and associated clinical comorbidities. The use of resources that minimize blood loss and the need for blood transfusions are essential to avoid complications. Tranexamic acid (TXA) has been highlighted for orthopedic surgeries to control intraoperative bleeding; however, there is a lack of large studies for its use in hip surgeries in patients with CP. This study aims to evaluate the efficacy and safety of tranexamic acid to reduce bleeding in pediatric patients with cerebral palsy undergoing surgical treatment for hip instability. A sample of 31 patients with CP who underwent surgical treatment for hip dislocation (hip adductor stretching, varization osteotomy of the proximal femur and acetabuloplasty using the Dega technique) was randomly divided into groups: control (n = 10) and TXA (n = 21). Preoperative and 24 h hemoglobin concentrations, the length of hospital stay (LHS), and intraoperative bleeding (IB) were analyzed. TXA significantly reduced the IB (p = 0.02). The variance in hemoglobin concentration was lower for the TXA group, but without statistical significance (p = 0.06). There was no difference in LHS. Also, no statistical difference was observed for the number of transfusions (p = 0.08). The findings provide evidence of the effectiveness of TXA in decreasing intraoperative bleeding and its safety for use in pediatric patients with cerebral palsy.
2.
Effect of tranexamic acid on intraoperative blood loss in pediatric osteotomies around the hip: Study protocol for a double-blind randomized placebo-controlled trial
van Kouswijk, H. W., Tolk, J. J., van Bommel, C. P., Reijman, M., Kempink, D. R., de Witte, P. B.
Journal of children's orthopaedics. 2023;17(5):404-410
Abstract
BACKGROUND Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures can result in significant blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent routinely administered in adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children and reported safe and beneficial for pediatric trauma, cardiac, and spinal surgery. However, for pediatric orthopedics, particularly for PFPOs, the available evidence is limited. Therefore, the current trial will investigate the potential reducing effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. METHODS In this single-center, double-blind, randomized placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs for any indication at our institution. Participants will be randomized to receive either TXA or placebo (saline) during anesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg), which is determined gravimetrically. Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), procedure time and hospital stay, and postoperative hemoglobin level changes. DISCUSSION This will be the first prospective study investigating the effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. Its results will help to determine whether it would be advisable to adopt preoperative TXA as a standard medication to minimize blood loss and prevent complications in this vulnerable population. TRIAL REGISTRATION EudraCT: 2022-002384-30. Prospectively registered on September 26, 2022.
3.
Efficacy of antifibrinolytics in pediatric orthopedic surgery: a systematic review and meta-analysis
Gausden EB, Brusalis CM, Qudsi RA, Swarup I, Fu M, Dodwell E, Fabricant PD
Journal of pediatric orthopedics. Part B. 2019
Abstract
Antifibrinolytics (AFs) stabilize blood clot formation and reduce bleeding. The purpose of this systematic review and meta-analysis was to determine the impact of AF use on intraoperative blood loss and the need for blood transfusion in pediatric orthopedic surgery. A systematic review was performed using Medline and Embase to identify studies that utilized AFs during pediatric orthopedic surgery. The primary outcome measure was intraoperative blood loss in ml. Secondary outcomes included blood transfusion and thromboembolic events. Pooled estimates were derived from a random-effects model. Heterogeneity was assessed using the Cochrane Q and I statistic. Meta-regression assessed if age or study quality modified the effect of AFs on blood loss. Publication bias was assessed using a funnel plot, Egger regression analysis, and the Kendall tau-test. Twenty studies, with a total of 1356 patients, were included. The mean difference in intraoperative blood loss was 653 ml [95% confidence interval (CI): 464-842 ml, P<0.001]. Similarly, the mean difference in percent of blood volume lost was 22% less in patients treated with AFs compared with controls (95% CI: 12-32, P<0.001). Patients treated with AFs had a lower odds of transfusion compared to controls (OR: 0.324; 95% CI: 0.105-0.997, P=0.049). The use of AF in pediatric orthopedic surgery results in decreased intraoperative blood loss and a lower risk of blood transfusion. The majority of studies included involve spine surgery; the benefits of AFs in extremity surgery in the pediatric population have yet to be delineated. Level of Evidence: Level II.