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
Recruitment status was Recruiting
Sponsor:
Centre Chirurgical Marie Lannelongue
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
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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:
MedlinePlus related topics:
Heart Surgery
Drug Information available for:
Tranexamic acid
U.S. FDA Resources
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 May 21, 2013