TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery. Improving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
52
Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours.
The control group will receive placebo in the form of normal saline. The volume administered will be identical to that of TXA intervention arm, and the infusion rate will be the same.
The Royal Children's Hospital
Melbourne, Victoria, Australia
Mean change between treatment arms in postoperative haemoglobin mass loss, measured on postoperative day 5 or day of discharge (whichever is earlier) and estimated using the HAEmoglobin Mass loss DuRing the periOperative Period (HAEMDROP) formula
HAEMDROP formula: mHb\_loss = BV\*(Hb\_initial - Hb\_final) + (TV \* 200), where: * mHb\_loss = Haemoglobin (Hb) mass loss in grams (g) * BV = Blood volume of the patient in litres (L). For paediatric patients, blood volume is \~75ml/kg. * Hb\_initial = Hb at the start of the period of interest (in grams per litre (g/L)). * Hb\_final = Hb at the end of the period of interest (in grams per litre (g/L)). * VT = volume (in L) of packed red blood cells transfused between Hb\_initial and Hb\_final. * \- 200 = 200g/L, the average haemoglobin level in a unit of blood. Multiplying this by the VT gives the haemoglobin mass transfused (in grams)
Time frame: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
Number of clinically significant seizures
Seizures experienced between Day of surgery until Day 5 post-operatively which: * are more frequent or more severe than the participant's pre-admission baseline. * necessitate additional clinical monitoring or intervention, as per institutional guidelines, beyond what is expected from the participant's pre-admission baseline seizure management. * seizures which require the administration of rescue medications which deviates from what is typical for the participant at baseline.
Time frame: Day of surgery until Day 5 post-operatively
Duration of hospital stay
Total duration of hospital stay, in calendar days, from date of admission (= day zero) to date of discharge.
Time frame: 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
The occurrence and duration of both planned and unplanned admission to the paediatric intensive care (PICU) unit during the participant's post-operative inpatient period.
Time frame: 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
Volume of packed red blood cells transfused during the period over which the primary outcome is measured (from end of operation to postoperative day 5 inclusive).
Time frame: 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
Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
Time frame: Day of surgery through to 30 days following surgery
Incidence of surgical wound infections - deep incisional surgical site infection
Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
Time frame: Day of surgery through to 90 days following surgery
Incidence of venous thromboembolism events requiring treatment
Incidence of venous thromboembolism requiring anticoagulant treatment in accordance with study institution guidelines will be captured.
Time frame: Day of surgery through to Day 5 post-surgery
Changes in in quality of life, measured in quality-adjusted life years (QALYs)
The EuroQol 5 dimensions (EQ-5D) by proxy will be completed by participants' parent/guardian. The EQ-5D is numbered from 0 to 100, where 100 means the best health you can imagine and 0 means the worst health you can imagine. From this, QALYs will be calculated and compared between intervention and control groups.
Time frame: Preoperatively, 3 months postoperatively, 6 months postoperatively
Changes in quality of life
Changes in quality of life will be captured by the CP-CHILD (caregiver) questionnaire, which measures: Social wellbeing \& acceptance, Feelings about functioning, Participation \& physical health, Emotional wellbeing \& self-esteem, Access to services, Pain \& impact of disability, Family health
Time frame: Preoperatively, 3 months postoperatively, 6 months postoperatively
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