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

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ClinicalTrials.gov Identifier: NCT01141127
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief 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.

Condition or disease Intervention/treatment Phase
Bleeding Drug: Tranexamic Acid Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens
Study Start Date : June 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141127


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT01141127     History of Changes
Other Study ID Numbers: CCML-2010-01
2010-018301-11 ( EudraCT Number )
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants