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NCT Number: NCT04811313

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

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.

Recruiting

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: Kapron

Caudal Epidural Block

Procedure

regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss

Other names: bupivacaine 0.25%

Placebo

Other

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

Primary outcomes

  1. amount of intraoperative blood loss

    Time frame: 24 hours

    calculated from the fall in red blood cell volume

Secondary outcomes

  1. Rate of blood transfusion

    Time frame: 24 hours

    either intraoperative or postoperative blood transfusion

  2. Incidence of adverse effects or complications of TXA

    Time frame: 24 hours

    e.g. thromboembolic events or perioperative seizures will be managed and recorded

  3. length of hospital stay

    Time frame: 24 hours

    readiness for hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Amira A Abdel-rahman, M.B.B.CH

CONTACT

[email protected]

01002595850

Shimaa A Hassan, M.D.

CONTACT

[email protected]

01002953253

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2021
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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