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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/46207
• EU PAS number:
  EUPAS43542
• Study ID:
  46207
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Anaemia is a medical condition where a component of your blood called haemoglobin (Hb) drops below a threshold (<130 g/l for men and <120 g/l for women). Iron deficiency is considered one of the most common causes of anaemia globally. Anaemia has been associated with increased morbidity and mortality in patients who have surgery. Treatment options for anaemia include red blood cell (RBC) transfusions, oral and intravenous iron transfusions as well as red blood cell boosting agents such as erythropoietin. Patient blood management (PBM) programs plan to reduce the need for blood transfusions whilst improving patient outcomes. By encompassing all aspects of patient evaluation and management relating to the transfusion process, it ensures that patients receive optimal treatment while avoiding inappropriate treatment options. There is a need to assess the impact of PBM programs on patient outcomes in routine care for patients undergoing surgery. This multi-country, multi-centre, retrospective observational study aims to compare the outcomes of adult patients who have undergone planned surgeries before a PBM program was implemented with patients who underwent planned surgeries after a PBM program was implemented. This study will be developed in four countries in Europe: Germany, Italy, Spain and United Kingdom. In each country 1 to 3 sites will be included in the study. These sites will be selected as they are known to have implemented a PBM program within the 7-year retrospective observation period (3-years prior to, 1 year during, and 3-years post PMB implementation). All eligible patients who underwent a planned major surgery during the retrospective observation period will be included from these hospitals. The study only involves the review and analysis of historical health data collected directly from hospital databases before being anonymized. Therefore, patients will not need to undergo any study specific activities.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Bellvitge University Hospital

St. Vincentius Klinike Germany, St. Marien Hospital Germany, Humanitas Research Hospital Italy, Bellvitge University Hospital Spain, Valladolid Clinic Hospital Spain, Gregorio Marañón Hospital Spain, Glasgow Royal Infirmary United Kingdom, Campus Biomedico Italy

Study timelines

Date when funding contract was signed

Actual: 10/12/2020

Study start date

Planned: 01/03/2021

Actual: 30/09/2021

Data analysis start date

Planned: 28/02/2022

Date of final study report

Planned: 31/07/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Vifor

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable