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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG

Criteria

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