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Voluven® in Paediatric Patients

NCT ID: NCT00860405

Last Updated: 2011-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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 adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.

Conditions

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Cardiac Surgery Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

2

Control drug: Human serum albumin (HSA 50g/L)

Group Type ACTIVE_COMPARATOR

Human serum albumin (HSA 50g/L)

Intervention Type DRUG

Human serum albumin (HSA 50g/L)

Interventions

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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.

Intervention Type DRUG

Human serum albumin (HSA 50g/L)

Human serum albumin (HSA 50g/L)

Intervention Type DRUG

Other Intervention Names

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Voluven®

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Van der Linden, Professor

Role: PRINCIPAL_INVESTIGATOR

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Hans Gombotz, Professor

Role: PRINCIPAL_INVESTIGATOR

AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Locations

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AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, , Austria

Site Status

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Countries

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Austria Belgium

Other Identifiers

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HE06-001-C P4

Identifier Type: -

Identifier Source: org_study_id