Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bleeding

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: INTERMITENT ADMINISTRATION<br>Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention | Drug: Tranexamic Acid<br>* Comparison of two dosage regimen of Tranexamic Acid<br>|
| Experimental: continuous administration of Tranexamic Acid<br>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 | Drug: Tranexamic Acid<br>* Comparison of two dosage regimen of Tranexamic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography |  | Blood samples are collected during the operative period within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography |  | blood samples collected during the operative period within the first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid in pediatric surgery, fibrinolysis and paediatric cardiac surgery