Back to resultsEffect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
Primary Purpose
Craniosynostosis Patients Undergoing Distraction Osteotomy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tranexamic Acid
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Craniosynostosis Patients Undergoing Distraction Osteotomy focused on measuring Tranexamic acid, pharmacokinetics, craniosynostosis
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Tranexamic acid
Arm Description
Outcomes
Primary Outcome Measures
Bleeding loss
Assessing the amount of bleeding during each intraop hours, and postoperative periods.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02180321
Brief Title
Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniosynostosis Patients Undergoing Distraction Osteotomy
Keywords
Tranexamic acid, pharmacokinetics, craniosynostosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Title
Tranexamic acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
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
Intervention Name(s)
normal saline
Intervention Description
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 Outcome Measure Information:
Title
Bleeding loss
Description
Assessing the amount of bleeding during each intraop hours, and postoperative periods.
Time Frame
from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
We'll reach out to this number within 24 hrs