craniosynostosis.
Conditions
Interventions
Intervention 1: Intervention group: Tranexamic acid. Intervention 2: Intervention group: Aprotinin. Intervention 3: Control group: No intervention.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Months to 2 Years
Inclusion criteria
Inclusion criteria: ? Age between 2 months and 2 years, both sex ? Single or multi-suture craniosynostosis including metopic, sagittal, unicoronal, and bicoronal synostoses ? Syndromic or non-syndromic craniosynostosis ? Hemoglobin level of equal or more than 13 mg/dl ? Patient’s parents or legal guardian agreement to sign the informed consent form
Exclusion criteria
Exclusion criteria: ? Indication for endoscopic craniosynostosis surgery ? History of coagulopathies or hemoglobinopathies in patient or first degree family (hemophilia, abnormal PT, PTT, INR tests, afibrinogenemia, congenital coagulatory factor deficiencies) ? Craniofacial surgeries ? Craniosynostosis recurrence ? Secondary craniosynostosis ? Abnormal renal function tests including abnormal BUN and Cr for age or family history of hereditary renal disease as polycystic kidney ? Allergy to Aprotinin, tested 30 minutes pre operation with 0.1 dose of therapeutic dose ? Congenital heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative and postoperative blood loss and blood transfusion and intervention-related mortality will be considered as primary outcomes. Timepoint: during the surgery, 4 and 24 hours after surgery. Method of measurement: The amount of blood loss as the result of surgery, intraoperative or postoperative.Estimation or calculation with formula. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Ebrahim soltani
Tehran University of Medical Sciences
Outcome results
None listed