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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Craniosynostosis Patients Undergoing Distraction Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type DRUG

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

Tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes