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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806533
First Posted: December 11, 2008
Last Update Posted: May 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
B. Braun Melsungen AG
  Purpose
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%

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806533


Locations
Austria
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
Germany
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
Dresden, Germany
Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
Hannover, Germany
Klinikum Mannheim
Mannheim, Germany
Olgahospital
Stuttgart, Germany
Italy
S. Orsola Hospital, University hospital
Bologna, Italy
Netherlands
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
Investigators
Principal Investigator: R. Suempelmann, Prof. Dr. MHH Hannover
  More Information