Comparison of outcomes in patients undergoing major planned surgeries before vs. after the implementation of Patient Blood Management (PBM): a retrospective study in four European countries

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:
  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:
  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