Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
This study has been completed.
Sponsor:
B. Braun Melsungen AG
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00806533
First received: December 10, 2008
Last updated: May 15, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Surgery |
Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years |
Further study details as provided by B. Braun Melsungen AG:
Primary Outcome Measures:
- incidence of adverse events [ Time Frame: peri-operative ] [ Designated as safety issue: Yes ]
| Enrollment: | 1130 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HES 130 / 0.42
paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
|
Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
solution for intravenous infusion applied according to SmPC
Other Name: Venofundin 6%, Tetraspan 6%
|
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
paediatric patients aged up to 12 years
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806533
Locations
| Austria | |
| Donauspital SMZ-OST | |
| Vienna, Austria | |
| Czech Republic | |
| Clinic of Children's Anaesthesiology and Resuscitation | |
| Brno, Czech Republic | |
| Clinic of Anaesthesiology and Resuscitation | |
| Praha, Czech Republic | |
| Germany | |
| Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden | |
| Dresden, Germany | |
| Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover | |
| Hannover, Germany | |
| Klinikum Mannheim | |
| Mannheim, Germany | |
| Olgahospital | |
| Stuttgart, Germany | |
| Italy | |
| S. Orsola Hospital, University hospital | |
| Bologna, Italy | |
| Netherlands | |
| Academic Mesich Centrum (AMC) | |
| Amsterdam, Netherlands | |
| Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ) | |
| Rotterdam, Netherlands | |
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
| Principal Investigator: | R. Suempelmann, Prof. Dr. | MHH Hannover |
More Information
Publications:
| Responsible Party: | Dr. Elke von Kleist, B. Braun Melsungen AG |
| ClinicalTrials.gov Identifier: | NCT00806533 History of Changes |
| Other Study ID Numbers: | HC-O-H-0509 |
| Study First Received: | December 10, 2008 |
| Last Updated: | May 15, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ClinicalTrials.gov processed this record on May 19, 2013