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

Craniosynostosis Patients Undergoing Distraction Osteotomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180321
• Other study ID #: 4-2014-0274
• Status: Completed
• Phase: N/A
• First received: June 30, 2014
• Last updated: April 11, 2016
• Start date: June 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Craniosynostoses
• Craniosynostosis Patients Undergoing Distraction Osteotomy

Intervention

Drug:
• Tranexamic Acid
10mg/kg of tranexamic acid loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr
• normal saline
10mg/kg of normal saline loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding loss	Assessing the amount of bleeding during each intraop hours, and postoperative periods.	from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr	No