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

Not Applicable

Completed

• Conditions: Craniosynostosis Patients Undergoing Distraction Osteotomy
• Interventions: Drug: Tranexamic Acid; Drug: normal saline

• Registration Number: NCT02180321
• Lead Sponsor: Yonsei University

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 Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients scheduled for distraction osteostomy under the diagnosis of Craniosynostosis.
2. Patients aged from 2 months to 6 years, either of whose patients had consented
3. ASA class 1 or 2

Exclusion Criteria

1. Coagulopathy with either PT > INR 1.5 or PLT < 50,000/dL
2. Patients took any NSAIDs within 2 days, or aspirin within 14 days prior to surgery
3. History of convulsive seizure, epilepsy, any brain surgery
4. Known drug allergic reaction to tranexamic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	-
Control	normal saline	-

Primary Outcome Measures

Name	Time	Method
Bleeding loss	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of