Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

NCT07672158 | Not Yet Recruiting Phase 3

• 1 other identifier: tablotrialvdrocprchmcri2025123
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Hip Surgery Corrective; Tranexamic Acid Use; Blood Loss, Surgical; Paediatrics; Orthopedics

Keywords

Cerebral Palsy; Hip surgery; Tranexamic Acid; Blood Loss; Orthopaedics

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (9)

• Number of clinically significant seizures

  Day of surgery until Day 5 post-operatively

• Duration of hospital stay

  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

  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

  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

  Day of surgery through to 30 days following surgery

Study Arms (2)

Tranexamic acid postoperative continuous infusion arm

EXPERIMENTAL

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.

Drug: Tranexamic Acid (IV)

Normal saline postoperative continuous infusion arm

PLACEBO COMPARATOR

The control group will receive placebo in the form of normal saline, which is physically identical to tranexamic acid and has been used in previous randomised placebo-controlled trials of tranexamic acid.

Drug: Placebo

Interventions

Tranexamic Acid (IV) DRUG

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.

Tranexamic acid postoperative continuous infusion arm

Placebo DRUG

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.

Normal saline postoperative continuous infusion arm

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• University of Melbourne: collaborator
• Royal Children's Hospital: collaborator

Study Sites (1)

The Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Cerebral Palsy; Blood Loss, Surgical; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Erich Rutz, MD, PhD

  The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erich Rutz, MD, PhD

CONTACT

+61 9345 7645; erich.rutz@rch.org.au

Daniel Gould, MD, PhD

CONTACT

+61 9345 7645; daniel.gould@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the research pharmacists dispensing the investigational product or placebo will be aware of treatment allocation. The surgeons, anaesthetists, nursing staff, investigators, participants, and outcome assessors will not be aware of treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The anonymised data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome. The source data for patients is collected routinely in the EMR. As this is routinely collected in clinical care, this won't be destroyed after the minimum retention periods. Data files created for the study, i.e. quality of life questionnaires, may be destroyed after 15 years post-trial completion or until child aged 25 years (whichever is the later).
• Access Criteria: The trial recognises the value of open data sharing and adherence to data sharing principles that align with applicable laws, regulations, and ethical guidelines. Therefore, anonymised data from this clinical trial will be made available via a controlled access data sharing mechanism. Interested researchers may request access to the data by submitting a formal data sharing request to the Sponsor. The request will be reviewed by the Sponsor and the Sponsor-Investigator, and any relevant Murdoch Children's Research Institute (MCRI) data sharing committee, considering factors such as scientific merit, data security, and adherence to the approved research objectives. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.

Locations

AU (1)