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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder; Pediatric; Intraoperative Blood Loss
• Intervention / Treatment: Drug: Tranexamic acid; Procedure: caudal epidural block; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shimaa A Hassan, M.D.; Phone Number: 01002953253; Email: shimaa.abbas@med.aun.edu.eg
• Study Contact Backup: Name: Amira A Abdel-rahman, M.B.B.CH; Phone Number: 01002595850; Email: amiraali441994@gmail.com

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Shimaa A Hassan, MD; Phone Number: 01002953253; Email: shimaa.abbas@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I - II
• Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Exclusion Criteria:

• Patient's guardian refusal to participate in the study.
• Children known to have pre-existing bleeding or coagulation disorders.
• Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
• History of epilepsy.
• History of renal insufficiency or failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T group; each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision.	Drug: Tranexamic acid; patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA; Other Names: Kapron
Active Comparator: TC group; each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.	Drug: Tranexamic acid; patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA; Other Names: Kapron; Procedure: caudal epidural block; regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss; Other Names: bupivacaine 0.25%
Active Comparator: C group; each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.	Procedure: caudal epidural block; regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss; Other Names: bupivacaine 0.25%
Placebo Comparator: P group; participants will receive the regular standard care without adding tranexamic acid or caudal epidural block	Other: Placebo; participants will receive standard care but neither TXA nor caudal epidural block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of intraoperative blood loss	calculated from the fall in red blood cell volume	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood transfusion	either intraoperative or postoperative blood transfusion	24 hours
Incidence of adverse effects or complications of TXA	e.g. thromboembolic events or perioperative seizures will be managed and recorded	24 hours
length of hospital stay	readiness for hospital discharge	24 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Amr M Sleem, M.D., Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: tranexamic acid in pediatric

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No