Status:
COMPLETED
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Surgery
Eligibility:
All Genders
Up to 12 years
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.
Eligibility Criteria
Inclusion
- 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
- contraindications according to SmPC
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1130 Patients enrolled
Trial Details
Trial ID
NCT00806533
Start Date
May 1 2006
End Date
December 1 2008
Last Update
May 19 2009
Active Locations (10)
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1
Donauspital SMZ-OST
Vienna, Austria
2
Clinic of Children's Anaesthesiology and Resuscitation
Brno, Czechia
3
Clinic of Anaesthesiology and Resuscitation
Prague, Czechia
4
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
Dresden, Germany