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Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial
Susan M Goobie1, Petra M Meier, Luis M Pereira
1Department of Anesthesia, Perioperative, and Pain Medicine, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA. susan.goobie@childrens.harvard.edu
Insights
Tranexamic acid (TXA) effectively reduces blood loss and transfusion needs in pediatric craniosynostosis surgery. This study confirms TXA
Area of Science:
- Pediatric Surgery
- Anesthesiology
- Hematology
Background:
- Pediatric craniosynostosis reconstruction surgery is associated with significant perioperative blood loss.
- Limited data exist on the efficacy of tranexamic acid (TXA) in reducing blood loss in pediatric surgical patients.
- TXA is an antifibrinolytic agent used to minimize bleeding in various surgical settings.
Purpose of the Study:
- To evaluate the efficacy of tranexamic acid (TXA) in reducing perioperative blood loss during pediatric craniosynostosis correction surgery.
- To assess the impact of TXA on blood transfusion requirements in this patient population.
Main Methods:
- A randomized, double-blind, placebo-controlled, parallel trial involving 43 children (2 months to 6 years).
- Participants received either a placebo or TXA (loading dose: 50 mg·kg⁻¹, infusion: 5 mg·kg⁻¹·h⁻¹) during surgery.
- Perioperative blood loss, transfusion volumes, and TXA plasma concentrations were measured.
Main Results:
- The TXA group demonstrated significantly lower mean blood loss (65 vs. 119 ml·kg⁻¹, P < 0.001) compared to the placebo group.
- Perioperative mean blood transfusion was significantly reduced in the TXA group (33 vs. 56 ml·kg⁻¹, P = 0.006).
- TXA administration reduced blood transfusion exposure by two-thirds (median 1 unit vs. 3 units, P < 0.001) and maintained plasma concentrations above antifibrinolytic thresholds.
Conclusions:
- Tranexamic acid is effective in reducing perioperative blood loss in children undergoing craniosynostosis reconstruction.
- TXA significantly decreases the need for blood transfusions in this pediatric surgical population.
- The findings support the use of TXA to improve outcomes in pediatric craniosynostosis surgery.
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.
