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Clinical Trials in Australia / NCT07672158
Starting soon Phase 3

Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

NCT07672158 · tracked via the Priya Life Science Australia tracker
Sponsor
Murdoch Childrens Research Institute
Phase
Phase 3
Started
2026-07
Last updated
2026-06-26

Condition(s) studied

Cerebral PalsyHip Surgery CorrectiveTranexamic Acid UseBlood Loss, SurgicalPaediatricsOrthopedics

Investigational drug(s) / intervention(s)

Tranexamic Acid (IV) →Placebo

Tranexamic Acid (IV): 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.

Placebo: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Known renal disorder (moderate to severe as per study institution guidelines)

Primary outcome measure(s)

  • 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 — Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
    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)

Trial sites (1)

FacilityCityRegionStatus
The Royal Children's Hospital Melbourne Victoria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07672158 on ClinicalTrials.gov ↗ ← All trials in Australia