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Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

This study is currently recruiting participants.
Verified June 2011 by Children's Hospital Boston
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01045356
First received: January 8, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Determine TXA blood levels in children having cardiac surgery with cardiopulmonary bypass. The current dosing recommendations will be utilized. [ Time Frame: multiple times thoughout surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: January 2010
Groups/Cohorts
children less than 2 months old
children 2 months to 12 months old
Children > 2 months old and less than or equal to 20 kg

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with congenital heart defects having cardiac surgery requiring cardiopulmonary bypass

Criteria

Inclusion Criteria:

  • congenital heart disease requiring surgical repair with cardiopulmonary bypass

Exclusion Criteria:

  • children weighing over 20 kg
  • family does not want to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045356

Contacts
Contact: Mark C Wesley, MD 617-355-6225 mark.wesley@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark C Wesley, MD     617-355-6225     mark.wesley@childrens.harvard.edu    
Principal Investigator: Mark C Wesley, MD            
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark C Wesley, MD     617-355-6225        
Principal Investigator: Mark C Wesley, MD            
Sponsors and Collaborators
Children's Hospital Boston
  More Information

Publications:

Responsible Party: Children's Hospital Boston, Anesthesia Foundation
ClinicalTrials.gov Identifier: NCT01045356     History of Changes
Other Study ID Numbers: x10-01-0006
Study First Received: January 8, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Tranexamic Acid
Antifibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013