Voluven® in Paediatric Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

December 31, 2010

Conditions
Cardiac SurgeryCardiopulmonary Bypass
Interventions
DRUG

HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)

Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.

DRUG

Human serum albumin (HSA 50g/L)

Human serum albumin (HSA 50g/L)

Trial Locations (2)

1020

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola, Brussels

4021

AKh Allgemeines Krankenhaus der Stadt Linz GmbH, Linz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY

NCT00860405 - Voluven® in Paediatric Patients | Biotech Hunter | Biotech Hunter