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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, non-interventional, multinational, European study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B05AA07) hydroxyethylstarch

  hydroxyethylstarch

Population studied

• Short description of the study population:
  The source population includes all patients fulfilling the inclusion and none of the exclusion criteria.; ; Inclusion Criteria; • Patients who received any of the HES 130 solutions listed in Annex 1a/1b after implementation of a set of risk minimisation measures at the respective HES-accredited hospital in the documentation period.; ; Exclusion Criteria; • Patients who participated in interventional clinical trials investigating HES up to 3 months prior to or during the recorded HES infusions(s)
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1749

Study design details

• Main study objective:
  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.
• Outcomes:
  Outcome measure is the number and proportion of patients whose treatment during the hospital stay did not adhere to the approved European PIs regarding indication, contraindications and dosage (posology). Analysis of non-adherence to one or more specifications made in the approved European PIs (concerning the indication, contraindications and dosage posology) will also be conducted for each single HES 130 prescription as statistical unit for assessment (instead of considering the patient as statistical unit) and will be presented as secondary measure.
• Data analysis plan:
  Due to the exploratory character of this study only descriptive statistics will be used for the analysis of the study variables. For continuous variables, mean ± standard deviation, median and quartile (25th, 75th percentile) and numbers of non-missing and missing values will be presented. For categorical variables, frequencies and percentage will be shown for each category and for missing values. All data will be examined for the overall population and subgroups (each country/ age group/ hospital type/hospital ward separately) specified by indication and contraindications according to the revised PI. The number and percentage of patients who received HES 130 and were documented as non-adherent to one or more of the specifications made in the PIs (concerning the indication, contraindications and dosage) will be evaluated for the overall patient population and will be displayed together with 95 % confidence intervals for the percentage.