Tranexamic Acid (TXA) in Pediatric Cardiac Surgery (Exacyl)

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.

• Active Comparator: INTERMITENT ADMINISTRATION
  Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention
  Intervention: Drug: Tranexamic Acid
• Experimental: continuous administration of Tranexamic Acid
  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
  Intervention: Drug: Tranexamic Acid

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