Status: Finalised First registered on: 07/09/2015
Last updated on: 08/06/2018
1. Study identification
EU PAS Register NumberEUPAS10897
Official titleRetrospective Drug Utilisation Study to investigate the routine use of Hydroxyethyl Starch (HES)- containing Infusion Solutions in Hospital
Study title acronymNA
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 concerning indication, posology (dosage) and contraindications.
Was this study requested by a regulator?Yes: Germany
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 nameKantar Health GmbH Germany
Centre locationMunich, Germany
Details of (Primary) lead investigator
Title Miss
Last name Apecechea
First name Mercedes
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?45
TBD, TBD
Countries in which this study is being conducted
International study

Austria
Belgium
Czech Republic
France
Germany
Hungary
Netherlands
Poland
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/201509/12/2015
Start date of data collection01/10/201518/05/2016
Start date of data analysis01/10/201605/12/2016
Date of interim report, if expected
Date of final study report31/03/201706/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesFresenius Kabi Deutschland GmbH100
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 1Else-Kröner-Straße 1
Address line 2 
Address line 3 
CityBad Homburg 
Postcode61352 
CountryGermany
Phone number (incl. country code)004961726864970 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Mr 
Last name Contact 
First name Public 
Address line 1Else-Kröner-Straße 1 
Address line 2 
Address line 3 
CityBad Homburg 
Postcode61352 
CountryGermany 
Phone number (incl. country code)004961726864970 
Alternative phone number 
Fax number (incl. country code) 
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