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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HES 130 / 0.42 | paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) | Drug | solution for intravenous infusion applied according to SmPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | peri-operative |
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Inclusion Criteria:
Exclusion Criteria:
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paediatric patients aged up to 12 years
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| Name | Affiliation | Role |
|---|---|---|
| R. Suempelmann, Prof. Dr. | MHH Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donauspital SMZ-OST | Vienna | Austria | ||||
| Clinic of Children's Anaesthesiology and Resuscitation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18647272 | Background | Sumpelmann R, Kretz FJ, Gabler R, Luntzer R, Baroncini S, Osterkorn D, Haeger MC, Osthaus WA. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). Paediatr Anaesth. 2008 Oct;18(10):929-33. doi: 10.1111/j.1460-9592.2008.02696.x. Epub 2008 Jul 21. |
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| Brno |
| Czechia |
| Clinic of Anaesthesiology and Resuscitation | Prague | Czechia |
| Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden | Dresden | Germany |
| Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover | Hanover | Germany |
| Klinikum Mannheim | Mannheim | Germany |
| Olgahospital | Stuttgart | Germany |
| S. Orsola Hospital, University hospital | Bologna | Italy |
| Academic Mesich Centrum (AMC) | Amsterdam | Netherlands |
| Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ) | Rotterdam | Netherlands |