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Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

NCT07672158 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-06-26

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Melbourne

    collaborator OTHER

  • Royal Children's Hospital

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Erich Rutz, MD, PhD · The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-08-31
Completion
2029-04-30

Countries

  • Australia

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672158 on ClinicalTrials.gov