Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Exacyl
Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens
2 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 23, 2014
July 1, 2014
1.5 years
June 4, 2010
July 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
Blood samples are collected during the operative period within 24 hours
Secondary Outcomes (1)
preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
blood samples collected during the operative period within the first 24 hours
Study Arms (2)
INTERMITENT ADMINISTRATION
ACTIVE COMPARATORAdministration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention
continuous administration of Tranexamic Acid
EXPERIMENTALAdministration 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
Interventions
Comparison of two dosage regimen of Tranexamic Acid
Eligibility Criteria
You may qualify if:
- children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350, France
Related Publications (1)
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.
PMID: 24418941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland COUTURIER, MD
CCML
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 10, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 23, 2014
Record last verified: 2014-07