Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018301-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERMITENT ADMINISTRATION | Active Comparator | Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention |
|
| continuous administration of Tranexamic Acid | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Comparison of two dosage regimen of Tranexamic Acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography | Blood samples are collected during the operative period within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography | blood samples collected during the operative period within the first 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roland COUTURIER, MD | CCML | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24418941 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided