Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid, caudal epidural block, Placebo.
- Who it may be relevant to
- Registry conditions: Intraoperative Blood Loss, Pediatric, Orthopedic Disorder. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Tranexamic acid
patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA - Procedure caudal epidural block
regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss - Other Placebo
participants will receive standard care but neither TXA nor caudal epidural block
Primary outcome measures
- amount of intraoperative blood loss [Time frame: 24 hours]
Secondary outcome measures (3)
- Rate of blood transfusion [Time frame: 24 hours]
- Incidence of adverse effects or complications of TXA [Time frame: 24 hours]
- length of hospital stay [Time frame: 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut University — Asyut
Identifiers
NCT: NCT04811313 · tranexamic acid in pediatric