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

NCT00806533 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1130

Last updated 2009-05-19

No results posted yet for this study

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.

Conditions

  • Surgery

Interventions

DRUG

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

solution for intravenous infusion applied according to SmPC

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • R. Suempelmann, Prof. Dr. · MHH Hannover

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Austria
  • Czechia
  • Germany
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806533 on ClinicalTrials.gov