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Completed

NCT Number: NCT00806533

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

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.

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Key information

Conditions

Surgery

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Donauspital SMZ-OST, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

Drug

solution for intravenous infusion applied according to SmPC

Other names: Venofundin 6%, Tetraspan 6%

Primary outcomes

  1. incidence of adverse events

    Time frame: peri-operative

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2008
Registry last updated
May 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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