Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

Bleeding Clinical Trial

— Exacyl  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141127
• Other study ID #: CCML-2010-01
• Secondary ID: 2010-018301-11
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2010
• Last updated: July 21, 2014
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 12 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Bleeding

Intervention

Drug:
• Tranexamic Acid
Comparison of two dosage regimen of Tranexamic Acid

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Plessis-Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography		Blood samples are collected during the operative period within 24 hours	No
Secondary	preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography		blood samples collected during the operative period within the first 24 hours	Yes