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.
Children (aged 4 to 16 years)
Diagnosis of cerebral palsy (CP). CP is an umbrella term under which many specific diagnoses are captured, and the clinical team at the study institution operates a comprehensive referral network to ensure patients with any relevant diagnoses are included.
Gross Motor Function Classification System (GMFCS) levels IV and V, with substantial hip displacement (>40% migration percentage per Australian Hip Surveillance Guidelines (Wynter M, Gibson N, Kentish M, Love S, Thomason P, Willoughby K, et al. Australian hip surveillance guidelines for children with cerebral palsy 2014. Australian Academy of Cerebral Palsy and Developmental Medicine. 2014.)), who are on the waitlist for bilateral proximal femoral varus derotational osteotomy (VDRO) +/- unilateral or bilateral pelvic osteotomy.
Haematological disorder (defined as an active genetic or acquired bleeding disorder)
Known hypersensitivity to tranexamic acid (TXA)
Children with promyelocytic leukaemia being treated with oral tretinoin will be excluded from the trial because combination with TXA has resulted in fatal thrombotic complications
Known coagulation defect
Parallel
Tranexamic Acid (IV)
DrugOnce the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours.
Placebo
DrugThe 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.
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)
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.
Duration of hospital stay
Total duration of hospital stay, in calendar days, from date of admission (= day zero) to date of discharge.
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.
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).
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Murdoch Childrens Research Institute
Lead sponsor
University of Melbourne
Collaborator
Royal Children's Hospital
Collaborator
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