Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Multi-country, multi-site, observational retrospective study
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

61934
Study design details

Main study objective

Compare the transfusion outcomes of patients undergoing major planned surgeries before vs. after the implementation of PBM, after adjusting for potential confounders

Outcomes

PRIMARY - Transfusion outcomes: - Transfusion rate, defined as percentage of patients with at least one RBC unit transfused - Nº of RBC units transfused, per patient, there are 3 categories of secondary outcomes: - Other clinical outcomes - Economic outcomes - Newly diagnosed comorbidities

Data analysis plan

The statistical analysis will be conducted with SAS® statistical software or R. Sociodemographic and clinical characteristics of study patients will be compared between the two study cohorts (pre- and post-PBM) in order to apply a propensity score-based method (PSBM) (separately by type of surgery, country and site), to balance potential confounders and allow the comparison of study outcomes between cohorts. The comparative analyses will be performed at overall level (including all types of surgeries and countries) and stratifying by type of surgery, country and site. A detailed statistical analysis plan (SAP) will be prepared and approved by the Sponsor before the data analysis initiation