Status:
COMPLETED
Voluven® in Paediatric Patients
Lead Sponsor:
Fresenius Kabi
Conditions:
Cardiac Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
2-12 years
Phase:
PHASE4
Brief Summary
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
Detailed Description
In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In...
Eligibility Criteria
Inclusion
- Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;
- Signed parental written informed consent and patient assent where achievable
Exclusion
- Known contraindication against scheduled concomitant medication;
- Total ECC volume \< 400 mL;
- ASA \> III
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00860405
Start Date
March 1 2009
End Date
December 1 2010
Last Update
November 2 2011
Active Locations (2)
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1
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, Austria, 4021
2
HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium, 1020