Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

May 15, 2009 updated by: B. Braun Melsungen AG

Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years

This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Donauspital SMZ-OST
  • Czech Republic
      • Brno, Czech Republic
        • Clinic of Children's Anaesthesiology and Resuscitation
      • Praha, Czech Republic
        • Clinic of Anaesthesiology and Resuscitation
  • Germany
      • Dresden, Germany
        • Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
      • Hannover, Germany
        • Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
      • Mannheim, Germany
        • Klinikum Mannheim
      • Stuttgart, Germany
        • Olgahospital
  • Italy
      • Bologna, Italy
        • S. Orsola Hospital, University hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Mesich Centrum (AMC)
      • Rotterdam, Netherlands
        • Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

paediatric patients aged up to 12 years

Description

Inclusion Criteria:

  • Age ≤12 years
  • Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III
  • infusion of Venofundin 6% or of Tetraspan 6%
  • elective intervention

Exclusion Criteria:

  • contraindications according to SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HES 130 / 0.42
paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
solution for intravenous infusion applied according to SmPC
Other Names:
  • Venofundin 6%, Tetraspan 6%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of adverse events
Time Frame: peri-operative
peri-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: R. Suempelmann, Prof. Dr., MHH Hannover

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • HC-O-H-0509

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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