Validation of a new dosing regimen for tranexamic acid in children under 1 year of age undergoing cardiac surgery
- Conditions
- Q20-Q28Congenital malformations of the circulatory system
- Registration Number
- DRKS00012781
- Lead Sponsor
- Institut für AnästhesiologieDt. Herzzentrum Müncen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
cardiac surgery requirin ECC, Age < 366 days
Exclusion Criteria
-missing informed consent
-known disturbance of hemostasis
- preoperative treatment with medications affecting hemostasis
- hypersensitivity on tranexamic acid
- known renal insufficiency
- age _>366 days
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is the testing of the overlap of the measured tranexamic acid concentration with the 90% confidence interval of the pharmacokinetc model.
- Secondary Outcome Measures
Name Time Method Testing whether the tranexamic acid concentration is within the therapeutic range (20 - 125 µg/ml) throughout the entire surgical procedure.