Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

Sponsor
Murdoch Childrens Research Institute
Study ID
NCT07672158
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
4 Years - 16 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Tranexamic acid postoperative continuous infusion arm
    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 Comparator: Normal saline postoperative continuous infusion arm
    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.

Primary Outcome Measure

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 [ Time Frame: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier) ]

Central Contacts

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