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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Intraoperative Blood Loss, Pediatric, Orthopedic Disorder

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Procedure: caudal epidural block
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T group<br>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<br>* patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA<br>* Other names: Kapron;|
| Active Comparator: TC group<br>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<br>* patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA<br>* Other names: Kapron;Procedure: caudal epidural block<br>* regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss<br>* Other names: bupivacaine 0.25%;|
| Active Comparator: C group<br>each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine. | Procedure: caudal epidural block<br>* regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss<br>* Other names: bupivacaine 0.25%;|
| Placebo Comparator: P group<br>participants will receive the regular standard care without adding tranexamic acid or caudal epidural block | Other: Placebo<br>* participants will receive standard care but neither TXA nor caudal epidural block<br>|

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 |