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

NCT ID: NCT01045356

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children less than 2 months old

No interventions assigned to this group

children 2 months to 12 months old

No interventions assigned to this group

Children > 2 months old and less than or equal to 20 kg

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mark C. Wesley

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/00000542-200208000-00016.

Reference Type RESULT
PMID: 12151929 (View on PubMed)

Other Identifiers

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x10-01-0006

Identifier Type: -

Identifier Source: org_study_id

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