Efficacy of Tranexamic Acid in Pediatric Craniosynostosis Surgery: A Double-blind, Placebo-controlled Trial

• Published in: Anesthesiology (Philadelphia) Vol. 114; no. 4; pp. 862 - 871
• Main Authors: GOOBIE, Susan M, MEIER, Petra M, ZURAKOWSKI, David, SETHNA, Navil F, PEREIRA, Luis M, MCGOWAN, Francis X, PRESCILLA, Randy P, SCHARP, Laurie A, ROGERS, Gary F, PROCTOR, Mark R, MEARA, John G, SORIANO, Sulpicio G
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.04.2011
• Subjects: Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Antifibrinolytic Agents - therapeutic use; Biological and medical sciences; Blood Loss, Surgical - prevention & control; Blood Transfusion - statistics & numerical data; Child; Child, Preschool; Craniosynostoses - surgery; Double-Blind Method; Female; Humans; Infant; Intraoperative Care; Male; Medical sciences; Tranexamic Acid - therapeutic use; Treatment Outcome; Human; Pediatrics; Nervous system diseases; Hemostatic; Craniosynostosis; Diseases of the osteoarticular system; Dysostosis; Surgery; Skull disease; Tranexamic acid; Anesthesia; Antifibrinolytic; Child
• ISSN: 0003-3022; 1528-1175
• DOI: 10.1097/ALN.0b013e318210fd8f

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. 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. 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. TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.