NCT01141127

Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Centre Chirurgical Marie Lannelongue · Academic / Other
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Comparison of two dosage regimen of Tranexamic Acid

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-06-10
• Last updated: 2014-07-23

Locations

1 site across 1 country: France