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

B. Braun

Status: Completed

Conditions: Surgery

Treatments: Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

Study type: Observational

Funder types: Industry

Identifiers

NCT00806533

HC-O-H-0509

Details and patient eligibility

About

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.

Enrollment: 1,130 patients

Sex: All

Ages: Under 12 years old

Volunteers: No 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

Trial design

1,130 participants in 1 patient group

HES 130 / 0.42

Description:

paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42

Treatment:

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