Status: Finalised First registered on: 25/02/2016
Last updated on: 13/01/2021
1. Study identification
EU PAS Register NumberEUPAS12540
Official titleRetrospective Drug Utilisation Study to investigate the routine use of Hydroxyethyl Starch (HES)-containing Infusion Solutions of B. Braun Melsungen AG in Hospitals
Study title acronym
Study typeObservational study
Brief description of the studyThe objective of the Drug Utilisation Study (DUS) is to assess the adherence of hospital physicians to the revised European Product Information (PI) [Summary of Product Characteristics (SmPC); Package Leaflet] for Hydroxyethyl Starch (HES) - containing medicinal products of B. Braun Melsungen AG concerning indication, posology (dosage) and contraindications.
Was this study requested by a regulator?Yes: Sweden
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameB. Braun Melsungen AG
Centre locationCarl-Braun-Str. 1, 34212 Melsungen, Germany
Details of (Primary) lead investigator
Title Mr
Last name NA
First name NA
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?40
Countries in which this study is being conducted
International study

Belgium
Czech Republic
France
Germany
Italy
Netherlands
Poland
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/09/201514/09/2015
Start date of data collection01/03/201601/03/2016
Start date of data analysis28/02/201728/02/2017
Date of interim report, if expected
Date of final study report06/11/201722/09/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesB.Braun Melsungen AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Contact
First name Scientific
Address line 1Carl-Braun-Str. 1
Address line 2 
Address line 3 
City34212 
Postcode 
CountryGermany
Phone number (incl. country code)00495661714498 
Alternative phone number 
Fax number (incl. country code) 
Email address dus-hes130-encepp@bbraun.com
Public Enquiries
Title Mr 
Last name Contact 
First name Public 
Address line 1Carl-Braun-Str. 1 
Address line 2 
Address line 3 
City34212 
Postcode 
CountryGermany 
Phone number (incl. country code)495661714498 
Alternative phone number 
Fax number (incl. country code) 
Email address dus-hes130-encepp@bbraun.com 
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