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Completed

NCT Number: NCT01141127

Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

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.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Comparison of two dosage regimen of Tranexamic Acid

Primary outcomes

  1. Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography

    Time frame: Blood samples are collected during the operative period within 24 hours

Secondary outcomes

  1. preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography

    Time frame: blood samples collected during the operative period within the first 24 hours

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study title

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

Acronym: Exacyl

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2010
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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