Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy
Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedStudy Start
First participant enrolled
April 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedNovember 17, 2025
November 1, 2025
9 months
March 19, 2021
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
amount of intraoperative blood loss
calculated from the fall in red blood cell volume
24 hours
Secondary Outcomes (3)
Rate of blood transfusion
24 hours
Incidence of adverse effects or complications of TXA
24 hours
length of hospital stay
24 hours
Study Arms (4)
T group
ACTIVE COMPARATOReach 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.
TC group
ACTIVE COMPARATOReach 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.
C group
ACTIVE COMPARATOReach participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
P group
PLACEBO COMPARATORparticipants will receive the regular standard care without adding tranexamic acid or caudal epidural block
Interventions
patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA
regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss
participants will receive standard care but neither TXA nor caudal epidural block
Eligibility Criteria
You may qualify if:
- ASA I - II
- Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amr M Sleem, M.D.
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lectrure of Anesthesia
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 23, 2021
Study Start
April 3, 2025
Primary Completion
January 1, 2026
Study Completion
March 1, 2026
Last Updated
November 17, 2025
Record last verified: 2025-11