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

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04811313
• Other study ID #: tranexamic acid in pediatric
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Shimaa A Hassan, M.D.
• Phone: 01002953253
• Email: shimaa.abbas[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intraoperative Blood Loss
• Musculoskeletal Diseases
• Orthopedic Disorder
• Pediatric

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of intraoperative blood loss	calculated from the fall in red blood cell volume	24 hours
Secondary	Rate of blood transfusion	either intraoperative or postoperative blood transfusion	24 hours
Secondary	Incidence of adverse effects or complications of TXA	e.g. thromboembolic events or perioperative seizures will be managed and recorded	24 hours
Secondary	length of hospital stay	readiness for hospital discharge	24 hours