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

This study has been completed.
Information provided by:
B. Braun Melsungen AG Identifier:
First received: December 10, 2008
Last updated: May 15, 2009
Last verified: May 2009
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.

Condition Intervention
Surgery Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years

Resource links provided by NLM:

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • incidence of adverse events [ Time Frame: peri-operative ]

Enrollment: 1130
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Venofundin 6%, Tetraspan 6%


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
paediatric patients aged up to 12 years

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00806533

Donauspital SMZ-OST
Vienna, Austria
Czech Republic
Clinic of Children's Anaesthesiology and Resuscitation
Brno, Czech Republic
Clinic of Anaesthesiology and Resuscitation
Praha, Czech Republic
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
Dresden, Germany
Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
Hannover, Germany
Klinikum Mannheim
Mannheim, Germany
Stuttgart, Germany
S. Orsola Hospital, University hospital
Bologna, Italy
Academic Mesich Centrum (AMC)
Amsterdam, Netherlands
Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)
Rotterdam, Netherlands
Sponsors and Collaborators
B. Braun Melsungen AG
Principal Investigator: R. Suempelmann, Prof. Dr. MHH Hannover
  More Information