NCT04811313

Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

Detailed description

the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited. We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.

Conditions

• Intraoperative Blood Loss
• Pediatric
• Orthopedic Disorder

Interventions

Type	Name	Description
DRUG	Tranexamic acid	patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA
PROCEDURE	caudal epidural block	regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss
OTHER	Placebo	participants will receive standard care but neither TXA nor caudal epidural block

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2021-03-23
• Last updated: 2025-11-17

Locations

1 site across 1 country: Egypt