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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806533

Enrollment

1130

Registered

2008-12-11

Start date

2006-05-31

Completion date

2008-12-31

Last updated

2009-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Brief summary

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.

Interventions

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

solution for intravenous infusion applied according to SmPC

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
incidence of adverse events	peri-operative

Countries

Austria, Czechia, Germany, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026