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
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(B05AA07) hydroxyethylstarch
hydroxyethylstarch
Population studied

Short description of the study population

Patients who were receiving any of the hydroxyethyl starch-containing medicinal products within the predefined timeframe in Belgium, Czech Republic, France, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.

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

3000
Study design details

Main study objective

The objective of the DUS is to assess the adherence of hospital physicians to the revised European PI for HES-containing medicina! products concerning indication, posology (dosage), and contraindications.

Outcomes

Outcome measure is the adherence to the concerned sections of therevised European PI for HES-containing medicinal products. Usage of these medicinal products according to indications, posolagy (dosage), and contraindications as specified in the revised PI ofthe HES solutions will be assessed.

Data analysis plan

Because of the exploratory character of this study only descriptive statistics will be performed. All parameters will be presented as mean +/- standard deviation for continuous normally distributed variables and median (25th, 75th percentile) for ordinal and continuous non-normal(skewed) variables. Categorical variables will be presented as percentage (and 95 % confidence interval). All analyses will be performed for the overall population as well as for each country separately. Ail data will be examined for the overall population and subgroups (each site/country separately) specified by indication andcontraindications according to the revised PI.