Health TrialsbyHealthPanel

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

ConditionsIntraoperative Blood LossPediatricOrthopedic Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I - II

Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid

    Drug

    patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA

  • caudal epidural block

    Procedure/Surgery

    regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss

  • Placebo

    Other intervention

    participants will receive standard care but neither TXA nor caudal epidural block

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: T groupActive comparator 1 intervention
Group B: TC groupActive comparator 2 interventions
Group C: C groupActive comparator 1 intervention
Group D: P groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

amount of intraoperative blood loss

calculated from the fall in red blood cell volume

Time frame
24 hours

Secondary outcomes

1

Rate of blood transfusion

either intraoperative or postoperative blood transfusion

Time frame
24 hours
2

Incidence of adverse effects or complications of TXA

e.g. thromboembolic events or perioperative seizures will be managed and recorded

Time frame
24 hours
3

length of hospital stay

readiness for hospital discharge

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
Apply now