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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045356
First Posted: January 11, 2010
Last Update Posted: July 30, 2015
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.
Information provided by (Responsible Party):
Mark C. Wesley, Children's Hospital Boston
  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:


Further study details as provided by Mark C. Wesley, 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 ]

Enrollment: 55
Study Start Date: January 2010
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01045356


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
  More Information

Publications:
Responsible Party: Mark C. Wesley, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01045356     History of Changes
Other Study ID Numbers: x10-01-0006
First Submitted: January 8, 2010
First Posted: January 11, 2010
Last Update Posted: July 30, 2015
Last Verified: June 2011

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