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临床试验/IRCT20200705048023N1
IRCT20200705048023N1尚未招募3 期

Evaluation of therapeutic safety and efficacy of tranexamic acid or aprotinin in absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery

Tehran University of Medical Sciences0 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
2 months 至 2 years(—)
性别
All

入选标准

  • ?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

排除标准

  • ?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

研究者

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