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Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
Sponsor: Murdoch Childrens Research Institute
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.
Official title: Postoperative Continuous Intravenous Tranexamic Acid Infusion to Reduce Blood Loss in Non-Ambulatory Children With Cerebral Palsy Following Bilateral Bony Hip Reconstructive Surgery: A Phase III Parallel-Group Randomised Placebo-Controlled Trial
Key Details
Gender
All
Age Range
4 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2026-07
Completion Date
2029-04
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The Royal Children's Hospital
Melbourne, Victoria, Australia