Voluven® in Paediatric Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• 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 Criteria:

• Known contraindication against scheduled concomitant medication;

• Total ECC volume < 400 mL;

• ASA > III