Retrospective Drug Utilisation Study to investigate the routine use of Hydroxyethyl Starch (HES)- containing Infusion Solutions in Hospital (NA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24380
• EU PAS number:
  EUPAS10897
• Study ID:
  24380
• Official title and acronym:
  Retrospective Drug Utilisation Study to investigate the routine use of Hydroxyethyl Starch (HES)- containing Infusion Solutions in Hospital (NA)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  France

  Germany

  Hungary

  Netherlands

  Poland

  Spain
• 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 concerning indication, posology (dosage) and contraindications.
• Study status:
  Finalised

Research institution and networks

Institutions

Kantar Health

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/07/2015

Actual: 09/12/2015

Study start date

Planned: 01/10/2015

Actual: 18/05/2016

Data analysis start date

Planned: 01/10/2016

Actual: 05/12/2016

Date of final study report

Planned: 31/03/2017

Actual: 06/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Fresenius Kabi Deutschland GmbH

Study protocol

Initial protocol

HE06-022PW-CNI-HESDUS_CSP blackened_all

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)