Trial record 9 of 31 for:    Craniosynostosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02180321
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : April 12, 2016
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Craniosynostosis Patients Undergoing Distraction Osteotomy Drug: Tranexamic Acid Drug: normal saline

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : June 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Control 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
Experimental: Tranexamic acid Drug: 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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02180321

Korea, Republic of
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT02180321     History of Changes
Other Study ID Numbers: 4-2014-0274
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by Yonsei University:
Tranexamic acid

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action