Outcomes of patients undergoing major planned surgery pre and post PBM
Research type
Research Study
Full title
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
IRAS ID
299112
Contact name
Sonya McKinlay
Contact email
Sponsor organisation
Vifor Pharma UK Limited
Duration of Study in the UK
0 years, 1 months, 31 days
Research summary
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.\n\nPatient 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.\n\nThis 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.\n\nThe UK arm of this study will be conducted at 1-2 hospitals in the United Kingdom who 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).\n\nAll eligible patients who underwent a planned major surgery during the retrospective observation period will be included from these hospitals. \n\nThe study only involves the review and analysis of historical health data collected directly from hospital databases before being anonymised. Therefore, patients will not need to undergo any study specific activities. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0152
Date of REC Opinion
8 Nov 2021
REC opinion
Favourable Opinion