STUDY OF TRANAXAMIC ACID DOSAGE IN PEDIATRIC CARDIAC SURGERY - DOSAGE TRANEXAMIC ACID IN PAEDIATRIC
Phase 1
- Conditions
- DOSAGE OF ACID TRANEXAMIC ACID IN BLOOD SAMPLES DURING PAEDIATRIC CARDIAC SURGERY
- Registration Number
- EUCTR2010-018301-11-FR
- Lead Sponsor
- Centre chirurgical Marie Lannelongue
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
CARDIAC SURGERY
CHILDREN WHEITING MORE THAN 10 KG AND LESS THAN 30 KG
HEMMORRAGIC INTERVENTIONS
Patients operated on by sternotomy
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
CHIDREN UNDER ONE YEAR OLD
ALLERICREACTION TO THE PRODUCT
Renal insuffisancy: The value of the creatinine clearance will be the one obtained by the Schwartz formula (Pediatrics. 1976, 58, 259-263). Any alteration of this clearance will be an indication cons
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: OBTAIN GUIDELINES FOR ADMINISTRATION OF THE PRODUCT IN CARDIAC SURGERY;Secondary Objective: STUDY IF FIBRINOLYSIS STILL EXISTS OR NOT<br>NEUROLOGIC TOXICITY;Primary end point(s): NO PRIMARY END POINT
- Secondary Outcome Measures
Name Time Method