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Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

2014-08-27 03:13:02 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Conditions

Bleeding

Intervention

Tranexamic Acid

Location

Centre Chirurgical Marie Lannelongue
Plessis-Robinson
France
92350

Status

Not yet recruiting

Source

Centre Chirurgical Marie Lannelongue

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:02-0400

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Medical and Biotech [MESH] Definitions

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