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

Assiut University

Status

Enrolling

Conditions

Orthopedic Disorder

Intraoperative Blood Loss

Pediatric

Treatments

Other: Placebo

Procedure: caudal epidural block

Drug: Tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04811313

tranexamic acid in pediatric

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

400 participants in 4 patient groups, including a placebo group

T group

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid

TC group

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid

Procedure: caudal epidural block

C group

Active Comparator group

Description:

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

Treatment:

Procedure: caudal epidural block

P group

Placebo Comparator group

Description: