Using Tranexamic Acid to Reduce Blood Loss in Pediatric Hip Surgery
Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
This study is testing if giving tranexamic acid can help reduce blood loss during hip surgery in children and lower the chances they need a blood transfusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT04811313 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of tranexamic acid (TXA), an antifibrinolytic agent, in reducing intraoperative blood loss and the need for blood transfusions in pediatric patients undergoing proximal femoral and acetabular osteotomies. The trial compares outcomes between patients receiving TXA and those receiving a placebo. By promoting hemostasis and preventing fibrin degradation, TXA aims to improve surgical outcomes in this vulnerable population. The study is designed to fill the gap in existing literature regarding the safety and efficacy of TXA in pediatric orthopedic procedures.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients classified as ASA I-II who are scheduled for acetabular or proximal femoral osteotomies.
Not a fit: Patients with pre-existing bleeding disorders, anemia, or those whose guardians refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce blood loss and transfusion needs during pediatric hip surgeries, leading to better recovery outcomes.
How similar studies have performed: While TXA has shown success in adult orthopedic surgeries and pediatric cardiac procedures, its application in pediatric orthopedic surgeries is less explored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Asyut
- Assiut University — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Shimaa A Hassan, M.D.
- Email: shimaa.abbas@med.aun.edu.eg
- Phone: 01002953253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.