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

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ClinicalTrials.gov Identifier: NCT01045356
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Mark C. Wesley, Boston Children’s Hospital

Tracking Information
First Submitted Date January 8, 2010
First Posted Date January 11, 2010
Last Update Posted Date July 30, 2015
Study Start Date January 2010
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01045356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass
Official Title Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with congenital heart defects having cardiac surgery requiring cardiopulmonary bypass
Condition Congenital Heart Disease
Intervention Not Provided
Study 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2011)
55
Original Estimated Enrollment
 (submitted: January 8, 2010)
45
Actual Study Completion Date December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01045356
Other Study ID Numbers x10-01-0006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mark C. Wesley, Boston Children’s Hospital
Study Sponsor Boston Children’s Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Boston Children’s Hospital
Verification Date June 2011