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

NCT04811313 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Not applicable

Started

2025-04-03

Last updated

2025-11-17

Condition(s) studied

Intraoperative Blood LossPediatricOrthopedic Disorder

Investigational drug(s) / intervention(s)

Tranexamic acid →caudal epidural blockPlacebo

Tranexamic acid: patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA

caudal epidural block: regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss

Placebo: participants will receive standard care but neither TXA nor caudal epidural block

Study 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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

18 Years

Healthy volunteers

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

Primary outcome measure(s)

amount of intraoperative blood loss — 24 hours
calculated from the fall in red blood cell volume

Trial sites (1)

Facility	City	Region	Status
Assiut University	Asyut	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04811313 on ClinicalTrials.gov ↗ ← All trials in Egypt