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

Boston Children's Hospital

Status: Completed

Conditions: Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01045356

x10-01-0006

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

55 participants in 3 patient groups

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