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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier:
NCT01141127
First received: June 4, 2010
Last updated: July 21, 2014
Last verified: July 2014

June 4, 2010
July 21, 2014
June 2010
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01141127 on ClinicalTrials.gov Archive Site
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 ]
preoperative plasma tranexamic acid concentration is measured usinfg high performance liquid chromatography [ Time Frame: blood samples collected during the operative period within the first 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Bleeding
Drug: Tranexamic Acid
Comparison of two dosage regimen of Tranexamic Acid
  • Active Comparator: INTERMITENT ADMINISTRATION
    Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention
    Intervention: Drug: 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
    Intervention: Drug: Tranexamic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
12 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01141127
CCML-2010-01, 2010-018301-11
No
Centre Chirurgical Marie Lannelongue
Centre Chirurgical Marie Lannelongue
Not Provided
Principal Investigator: Roland COUTURIER, MD CCML
Centre Chirurgical Marie Lannelongue
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP