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Voluven® in Paediatric Patients

NCT00860405 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2011-11-02

Study results available
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Summary

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

Conditions

  • Cardiac Surgery
  • Cardiopulmonary 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)

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Philippe Van der Linden, Professor · HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

  • Hans Gombotz, Professor · AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-08-31
Completion
2010-12-31

Countries

  • Austria
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860405 on ClinicalTrials.gov