Intraoperative Blood Loss, Pediatric, Orthopedic Disorder
Conditions
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.
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
DRUGTranexamic acid
patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA
PROCEDUREcaudal epidural block
regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss
OTHERPlacebo
participants will receive standard care but neither TXA nor caudal epidural block
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| amount of intraoperative blood loss | 24 hours | calculated from the fall in red blood cell volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood transfusion | 24 hours | either intraoperative or postoperative blood transfusion |
| Incidence of adverse effects or complications of TXA | 24 hours | e.g. thromboembolic events or perioperative seizures will be managed and recorded |
| length of hospital stay | 24 hours | readiness for hospital discharge |
Countries
Egypt
Contacts
Primary ContactShimaa A Hassan, M.D.
Backup ContactAmira A Abdel-rahman, M.B.B.CH
Outcome results
None listed