Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

NCT ID: NCT01141127

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

INTERMITENT ADMINISTRATION

Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Comparison of two dosage regimen of Tranexamic Acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Comparison of two dosage regimen of Tranexamic Acid

Interventions

Tranexamic Acid

Comparison of two dosage regimen of Tranexamic Acid

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland COUTURIER, MD

Role: PRINCIPAL_INVESTIGATOR

CCML

Locations

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Countries

France

References

Couturier R, Rubatti M, Credico C, Louvain-Quintard V, Anerkian V, Doubine S, Vasse M, Grassin-Delyle S. Continuous or discontinuous tranexamic acid effectively inhibits fibrinolysis in children undergoing cardiac surgery with cardiopulmonary bypass. Blood Coagul Fibrinolysis. 2014 Apr;25(3):259-65. doi: 10.1097/MBC.0000000000000051.

Reference Type: DERIVED

PMID: 24418941 (View on PubMed)

Other Identifiers

2010-018301-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCML-2010-01

Identifier Type: -

Identifier Source: org_study_id