Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a parallel-group randomised placebo-controlled trial of postoperative tranexamic acid vs placebo in children with CP undergoing bilateral varus derotational osteotomy (VDRO) surgery. The allocation ratio is 1:1 (placebo: intervention), and the trial will be powered to detect a difference in postoperative blood loss calculated using a haemoglobin mass loss formula. Improving perioperative outcomes is a high priority in this patient population given the high risk of bleeding from this surgical intervention and the reduced physiological reserve in these children. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations. This is an embedded superiority randomised placebo-controlled patient-/treating team-/assessor-blinded trial comparing tranexamic acid with placebo in reducing blood loss following bilateral bony hip reconstructive surgery in non-ambulatory children with cerebral palsy. Primary objective: to evaluate the impact of postoperative continuous intravenous TXA infusion, compared with placebo in the form of normal saline, on blood loss in non-ambulatory children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Secondary objectives: to investigate the safety and tolerability of postoperative tranexamic acid in children with CP undergoing bilateral VDRO surgery with or without pelvic osteotomy, and to evaluate the health economic impact of postoperative tranexamic acid in children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. To the best of the study team's knowledge this will be the first randomised controlled trial to investigate postoperative intravenous TXA in a paediatric surgical population. Trial population: Non-ambulant children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy. Planned sample size is 52 participants (26 in each group: placebo and intervention). Study setting: Single site electronic medical record (EMR) embedded trial in the software platform EpicTM at The Royal Children's Hospital (RCH). Trial intervention: after cessation of the intraoperative tranexamic acid infusion, and once the patient has been transferred to the recovery bay, the postoperative infusion will commence comprising 10mg/kg/hr intravenous TXA for 24 hours. Placebo: equivalent volume of visually identical normal saline will be infused at the same rate as the TXA. Recruitment: It is anticipated that recruitment will commence in June 2026 and cease August 2028, with the last participant completing 6-month follow up period by April 2029. Participant duration: It is anticipated that duration of participation will be approximately four to six months. The time between initial identification as potentially eligible to date of surgery is three months maximum, length of stay is approximately seven days, and post-operative follow-up is 6 months.

• Number of clinically significant seizures [Срок оценки: Day of surgery until Day 5 post-operatively]
• Duration of hospital stay [Срок оценки: Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days]
• Duration of paediatric intensive care unit admission [Срок оценки: Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours]
• Volume of packed red blood cells transfused [Срок оценки: From end of operation to postoperative day 5 or day of discharge (whichever comes first)]
• Incidence of surgical wound infections - superficial incisional surgical site infection [Срок оценки: Day of surgery through to 30 days following surgery]
• Incidence of surgical wound infections - deep incisional surgical site infection [Срок оценки: Day of surgery through to 90 days following surgery]
• Incidence of venous thromboembolism events requiring treatment [Срок оценки: Day of surgery through to Day 5 post-surgery]
• Changes in in quality of life, measured in quality-adjusted life years (QALYs) [Срок оценки: Preoperatively, 3 months postoperatively, 6 months postoperatively]
• Changes in quality of life [Срок оценки: Preoperatively, 3 months postoperatively, 6 months postoperatively]