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

December 10, 2008
May 15, 2009
May 2006
December 2008   (final data collection date for primary outcome measure)
incidence of adverse events [ Time Frame: peri-operative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00806533 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

paediatric patients aged up to 12 years

Surgery
Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
solution for intravenous infusion applied according to SmPC
Other Name: Venofundin 6%, Tetraspan 6%
HES 130 / 0.42
paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
Intervention: Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
Sümpelmann R, Kretz FJ, Gäbler R, Luntzer R, Baroncini S, Osterkorn D, Haeger MC, Osthaus WA. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). Paediatr Anaesth. 2008 Oct;18(10):929-33. Epub 2008 Jul 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1130
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Germany,   Italy,   Netherlands
 
NCT00806533
HC-O-H-0509
No
Dr. Elke von Kleist, B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Principal Investigator: R. Suempelmann, Prof. Dr. MHH Hannover
B. Braun Melsungen AG
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP