Clinical Trial: Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.

Detailed Summary:
Sponsor: Yonsei University

Current Primary Outcome: Bleeding loss [ Time Frame: from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr ]

Assessing the amount of bleeding during each intraop hours, and postoperative periods.


Original Primary Outcome: Intra/postop bleeding amounts [ Time Frame: postoperative 48hr ]

Assessing the amount of bleeding during each intraop hours, and postoperative periods for the changes in coagulopathy


Current Secondary Outcome:

Original Secondary Outcome: Intra/postop transfusion requirements [ Time Frame: postoperative 48hr ]

Assessing the transfusion requirements during each intraop hours, and postoperative periods for the changes in coagulopathy.


Information By: Yonsei University

Dates:
Date Received: June 30, 2014
Date Started: June 2013
Date Completion:
Last Updated: April 11, 2016
Last Verified: April 2016