Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
- Registration Number
- NCT00806533
- Lead Sponsor
- B. Braun Melsungen AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1130
- 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
- contraindications according to SmPC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HES 130 / 0.42 HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
- Primary Outcome Measures
Name Time Method incidence of adverse events peri-operative
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Clinic of Children's Anaesthesiology and Resuscitation
🇨🇿Brno, Czech Republic
Donauspital SMZ-OST
🇦🇹Vienna, Austria
Clinic of Anaesthesiology and Resuscitation
🇨🇿Praha, Czech Republic
Klinikum Mannheim
🇩🇪Mannheim, Germany
Olgahospital
🇩🇪Stuttgart, Germany
S. Orsola Hospital, University hospital
🇮🇹Bologna, Italy
Academic Mesich Centrum (AMC)
🇳🇱Amsterdam, Netherlands
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
🇩🇪Dresden, Germany
Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)
🇳🇱Rotterdam, Netherlands