Trial | NCT01141127  Report issue

Title

Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
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 pediatric population. Only a few studies report a clinical efficacy with different dosages. The purpose of this study is to determine the plasma level of TXA using two different administrations methods: continuous versus intermittent. The second objective is to determine whether fibrinolysis decreased. The population consists in children weighting 10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.
Study Started
Jun 30
2010
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Jul 23
2014
Estimate

Drug Tranexamic Acid

Comparison of two dosage regimen of Tranexamic Acid

INTERMITENT ADMINISTRATION Active Comparator

Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention

continuous administration of Tranexamic Acid Experimental

Administration of 10 mg /Kg of Tranexamic Acid at the beginning in the priming pump and continuous infusion of 1 mg/KG of Tranexamic Acid until the end of the intervention

Criteria 

Inclusion Criteria:

children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic

Exclusion Criteria:

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
No Results Posted