Retrospective drug utilisation study to investigate the routine use of hydroxyethyl starch (HES)-containing infusion solutions of B. Braun Melsungen AG in hospitals

Study identification

• EU PAS number:
  EUPAS12540
• Study ID:
  38989
• Official title and acronym:
  Retrospective drug utilisation study to investigate the routine use of hydroxyethyl starch (HES)-containing infusion solutions of B. Braun Melsungen AG in hospitals
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  France

  Germany

  Italy

  Netherlands

  Poland

  Spain

  Sweden
• Study description:
  The 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:14/09/2015

Actual:14/09/2015

Study start date

Planned:01/03/2016

Actual:01/03/2016

Data analysis start date

Planned:28/02/2017

Actual:28/02/2017

Date of final study report

Planned:06/11/2017

Actual:22/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

B.Braun Melsungen AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)