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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02180321

Enrollment

Registered

2014-07-02

Start date

2013-06-30

Completion date

2016-03-31

Last updated

2016-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostosis Patients Undergoing Distraction Osteotomy

Keywords

Tranexamic acid, pharmacokinetics, craniosynostosis

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.

Interventions

DRUGTranexamic 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

DRUGnormal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026