NCT00860405

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 19, 2011

Completed
Last Updated

November 2, 2011

Status Verified

October 1, 2011

Enrollment Period

1.4 years

First QC Date

February 27, 2009

Results QC Date

August 12, 2011

Last Update Submit

November 1, 2011

Conditions

Cardiac SurgeryCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • Total Volume of Colloid Solution Required Intraoperatively

    Total volume of study drug plus rescue colloid, if applicable

    Day 1 (intraoperatively)

Secondary Outcomes (4)

  • Mean Arterial Pressure (MAP)

    Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)

  • Fluid Input

    2 days

  • Fluid Output

    2 days

  • Fluid Balance

    2 days

Other Outcomes (4)

  • Calculated Perioperative Red Blood Cell (RBC) Loss

    2 days

  • Length of Stay on the Intensive Care Unit (ICU)

    From admission to ICU until discharge from ICU

  • Mortality

    From screening to end of follow-up

  • +1 more other outcomes

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

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

Drug: Human serum albumin (HSA 50g/L)

Interventions

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

Also known as: Voluven®
1
Human serum albumin (HSA 50g/L)DRUG

Human serum albumin (HSA 50g/L)

2

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Known contraindication against scheduled concomitant medication;
  • Total ECC volume \< 400 mL;
  • ASA \> III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, 4021, Austria

Location

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesSodium ChlorideHES 130-0.4SolutionsSerum Albumin, Human

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical PreparationsSerum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Results Point of Contact

Title
Professor Dr. Martin Westphal, Chief Medical Officer
Organization
Fresenius Kabi Aktiengesellschaft, Else-Kröner-Str. 1, 61352 Bad Homburg, Germany
martin.westphal@fresenius-kabi.com
+49 6172 686 7280

Study Officials

  • Philippe Van der Linden, Professor

    HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

    PRINCIPAL INVESTIGATOR

  • Hans Gombotz, Professor

    AKh Allgemeines Krankenhaus der Stadt Linz GmbH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 12, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

November 2, 2011

Results First Posted

September 19, 2011

Record last verified: 2011-10

Locations

BE(1)AU(1)