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IRCT20200705048023N1 IRCT 2020-07-07 Tehran University of Medical Sciences Effect of tranexamic acid and aprotinin in absolute blood loss in pediatric neurosurgery Evaluation of therapeutic safety and efficacy of tranexamic acid or aprotinin in absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery 2020-07-22 anticipated 90 Complete https://irct.ir/trial/49434 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: The order of study interventions would be determined using 6-block computer-based randomization master list. (http://randomization.ir) Random allocation: The intervention for each patient would be determined accordingly to randomization cards and their orders would be accordingly to randomization master list. Concealment: The randomization cards would be placed in opaque pockets and only in time of random allocation, one pocket would be opened for one patient, Blinding description: each patient will allocated to one of 3 groups randomly. the randomization will performed by a separate research team (without informing the surgeon, anesthesiologist and personnel of operation room. the prescription of the drug will performed by anesthesiology service (without informing the surgeon from the intervention group). the assessment during surgery will done by surgical service and the assessment after surgery will performed by ICU service(without informing the surgeon from the intervention group). 3 craniosynostosis. Intervention 1: Intervention group: Tranexamic acid. Intervention 2: Intervention group: Aprotinin. Intervention 3: Control group: No intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Zahra Ebrahim soltani
no 12
tehran Iran (Islamic Republic of) 1463773117 +98 21 4421 0127 zahra_esoltani@yahoo.com Tehran University of Medical Sciences scientific Zahra Ebrahim soltani
no 12
tehran Iran (Islamic Republic of) 1463773117 +98 21 4421 0127 zahra_esoltani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of)  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 2 months 2 years Both  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 Treatment - Drugs Treatment - Drugs N/A Intervention group: Tranexamic acid Intervention group: Aprotinin Control group: No intervention 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. Tehran University of Medical Sciences Approved 2020-07-04 ethics committee of Children Medical Center Children Medical Center, Qarib street tehran Tehran Iran (Islamic Republic of)