Effect of tranexamic acid and aprotinin in absolute blood loss in pediatric neurosurgery
- Conditions
- craniosynostosis.
- Registration Number
- IRCT20200705048023N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 90
?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
?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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method