title: Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial.
abstract: 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.
authors.affiliation: Department of Anesthesia, Perioperative, and Pain Medicine, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA. susan.goobie@childrens.harvard.edu
authors.forename: Susan M
authors.initials: SM
authors.lastname: Goobie
authors.forename: Petra M
authors.initials: PM
authors.lastname: Meier
authors.forename: Luis M
authors.initials: LM
authors.lastname: Pereira
authors.forename: Francis X
authors.initials: FX
authors.lastname: McGowan
authors.forename: Randy P
authors.initials: RP
authors.lastname: Prescilla
authors.forename: Laurie A
authors.initials: LA
authors.lastname: Scharp
authors.forename: Gary F
authors.initials: GF
authors.lastname: Rogers
authors.forename: Mark R
authors.initials: MR
authors.lastname: Proctor
authors.forename: John G
authors.initials: JG
authors.lastname: Meara
authors.forename: Sulpicio G
authors.initials: SG
authors.lastname: Soriano
authors.forename: David
authors.initials: D
authors.lastname: Zurakowski
authors.forename: Navil F
authors.initials: NF
authors.lastname: Sethna
mesh_terms: D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D002648:Child; D002675:Child, Preschool; D003398:Craniosynostoses / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007430:Intraoperative Care; D008297:Male; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid