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

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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Key information

Conditions

Craniosynostosis Patients Undergoing Distraction Osteotomy Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tranexamic Acid

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

normal saline

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jul 2, 2014
Registry last updated: Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed