TXA-RCT

Background 

Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated in (often asymptomatic) children to prevent future hip problems. These procedures can coincide with significant blood loss, that can lead to severe complications. Tranexamic acid (TXA) is an antifibrinolytic agent which is routinely administered during adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children, and reported safe and beneficial for paediatric trauma, cardiac, and spinal surgery. However, for paediatric orthopaedics, in particular PFPOs, the available evidence is limited. Therefore, in this trial, the effect of preoperative TXA on intraoperative blood loss in paediatric PFPOs will be further investigated.

Methods

In this single-centre, double-blind, randomised placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs at our institution for any indication. Participants will be randomized to receive either TXA or placebo (saline) during anaesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg). Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), haemoglobin level changes, and type and amount of blood product transfusions.

Significance

This will be the first prospective study investigating the effect of TXA on intraoperative blood loss in paediatric PFPOs. Its results will help determine whether preoperative TXA-administration should be standard care to reduce intraoperative blood loss in children undergoing PFPOs.

Funds and Grants

This research received a grant from the Sophia fund, Johanna Kinderfonds and an EPOS research grant