Tranexamic Acid (TXA) in Pediatric Cardiac Surgery (Exacyl)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Centre Chirurgical Marie Lannelongue.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier:
NCT01141127
First received: June 4, 2010
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Bleeding
Drug: Tranexamic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

Resource links provided by NLM:


Further study details as provided by Centre Chirurgical Marie Lannelongue:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: June 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: INTERMITENT ADMINISTRATION
Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention
Drug: Tranexamic Acid
Comparison of two dosage regimen of Tranexamic Acid
Experimental: continuous administration of 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
Drug: Tranexamic Acid
Comparison of two dosage regimen of Tranexamic Acid

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.

  Eligibility

Ages Eligible for Study:   12 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141127

Contacts
Contact: Arezki AGHER, CRA 00 33( 1)40942596 a.agher@ccml.fr

Locations
France
Centre Chirurgical Marie Lannelongue Recruiting
Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
Principal Investigator: Roland COUTURIER, MD CCML
  More Information

No publications provided

Responsible Party: P.HERVE/ Responsable de l'unité de Recherche Clinique, Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT01141127     History of Changes
Other Study ID Numbers: CCML-2010-01, 2010-018301-11
Study First Received: June 4, 2010
Last Updated: September 17, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Chirurgical Marie Lannelongue:
tranexamic acid in pediatric surgery
fibrinolysis and paediatric cardiac surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014