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

NCT02180321 | Completed

• 1 other identifier: 4-2014-0274
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostosis Patients Undergoing Distraction Osteotomy

Keywords

Tranexamic acid; pharmacokinetics; craniosynostosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: normal saline

Tranexamic acid

EXPERIMENTAL

Drug: Tranexamic Acid

Interventions

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

Tranexamic acid

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

Control

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Craniosynostoses

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

KR (1)