Status:
COMPLETED
Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Lead Sponsor:
Centre Chirurgical Marie Lannelongue
Conditions:
Bleeding
Eligibility:
All Genders
12-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.
Detailed Description
Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is unknown in the pediatr...
Eligibility Criteria
Inclusion
- children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic
Exclusion
- the patients undergoing a surgical procedure short and simple
- patients with past history of convulsions neurologiques especially allergies to the TA
- patients with renal insufficiency
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01141127
Start Date
June 1 2010
End Date
December 1 2011
Last Update
July 23 2014
Active Locations (1)
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1
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350