Effect of tranexamic acid on intraoperative blood loss in pediatric osteotomies around the hip: Study protocol for a double-blind randomized placebo-controlled trial.

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.