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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00806533
First received: December 10, 2008
Last updated: May 15, 2009
Last verified: May 2009
  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

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

Primary Outcome Measures:
  • incidence of adverse events [ Time Frame: peri-operative ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Dr. Elke von Kleist, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00806533     History of Changes
Other Study ID Numbers: HC-O-H-0509
Study First Received: December 10, 2008
Last Updated: May 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 14, 2014