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NCT01045356 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01045356
Other study ID # x10-01-0006
Secondary ID
Status Completed
Phase N/A
First received January 8, 2010
Last updated July 29, 2015
Start date January 2010
Est. completion date December 2014

Study information
Verified date June 2011
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 21 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dowd NP, Karski JM, Cheng DC, Carroll JA, Lin Y, James RL, Butterworth J. Pharmacokinetics of tranexamic acid during cardiopulmonary bypass. Anesthesiology. 2002 Aug;97(2):390-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Determine TXA blood levels in children having cardiac surgery with cardiopulmonary bypass. The current dosing recommendations will be utilized. multiple times thoughout surgery No
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