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

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, multi-centre study

Study drug and medical condition

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

  hydroxyethylstarch

Population studied

• Short description of the study population:
  Hospital physicians in Belgium, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain and Sweden using any hydroxyethyl starch (HES) products of B. Braun Melsungen AG.
• 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:
  3.000

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 medicinal products of B. Braun Melsungen AG concerning indication, posology (dosage) and contraindications.
• Outcomes:
  Outcome measure is the adherence to the concerned sections of the revised European PI. Usage of these medicinal products according to indications, posology (dosage), and contraindications as specified in the revised PI of the 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. All data will be examined for the overall population and subgroups (each site/country separately) specified by indication and contraindications according to the revised PI.