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Clinical Trials/IRCT20200705048023N1
IRCT20200705048023N1
Not yet recruiting
Phase 3

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 sites90 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Tehran University of Medical Sciences
Enrollment
90
Status
Not yet recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • •?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

Outcomes

Primary Outcomes

Not specified

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