Retrospective, Multinational, Drug Utilisation Study (DUS) to Investigate the Routine Use of Hydroxyethyl Starch (HES)-containing Infusion Solutions in HES-Accredited European (EU) Hospitals after Implementation of a Set of Risk Minimisation Measures (HE06-027-CNI)

Study identification

• EU PAS number:
  EUPAS32145
• Study ID:
  46150
• Official title and acronym:
  Retrospective, Multinational, Drug Utilisation Study (DUS) to Investigate the Routine Use of Hydroxyethyl Starch (HES)-containing Infusion Solutions in HES-Accredited European (EU) Hospitals after Implementation of a Set of Risk Minimisation Measures (HE06-027-CNI)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Hungary

  Italy

  Netherlands

  Poland

  Spain
• Study description:
  The primary objective of the imposed DUS is to assess the non-adherence of physicians in HES-accredited hospitals to the approved European Product Information regarding indication for use, contraindications and posology (dosage) for HES 130-containing medicinal products in clinical routine after implementation of a set of risk minimisation measures. This allows to evaluate the effectiveness of these measures.
• 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

Actual:15/04/2019

Study start date

Planned:12/02/2020

Actual:19/02/2020

Data analysis start date

Actual:16/11/2020

Date of final study report

Planned:16/07/2020

Actual:06/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Fresenius Kabi Deutschland GmbH, 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)