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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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

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Intraoperative Blood Loss Pediatric Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

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

caudal epidural block

Intervention Type PROCEDURE

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

C group

each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.

Group Type ACTIVE_COMPARATOR

caudal epidural block

Intervention Type PROCEDURE

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

P group

participants will receive the regular standard care without adding tranexamic acid or caudal epidural block

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Tranexamic acid

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

Intervention Type DRUG

caudal epidural block

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

Intervention Type PROCEDURE

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Kapron bupivacaine 0.25%

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No