Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

Phase 2

Completed

• Conditions: Bleeding
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT01141127
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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 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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERMITENT ADMINISTRATION	Tranexamic Acid	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	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography	blood samples collected during the operative period within the first 24 hours

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Plessis-Robinson, France