Study of the Efficacy of a Patient Blood Management Program Implemented in Patients Undergoing Curative Gastric Cancer Resection

The Spanish EURopEan CanCer Audit (EURECCA) Esophagogastric Cancer Group is a surgical quality improvement project, linked to the EURECCA network in Europe. EURECCA's population-based registry prospectively collects clinical data from all public hospitals in the participating regions providing them with their outcomes benchmarked against other hospitals. Ninety variables with detailed definitions are prospectively collected from each patient by the reference surgeon at each institution. Validation of completeness and accuracy of data registration (period 2014-2017) has recently been performed revealing a completeness rate of 97% and an accuracy rate of 95% (ClinicalTrials.gov, NCT03541629, pending publication).

During a workshop of the Spanish EURECCA Esophagogastric Cancer Group in May 2014, a wide heterogeneity in perioperative transfusion policies among hospitals was detected. After several meetings, a unified protocol of PBM measures (upPBM) was agreed in February 2016. Briefly, the upPBM included strategies to address two PBM pillars: anemia detection and treatment according to the algorithm described in Figure 1; and a restrictive transfusion practice according to national guidelines for transfusion triggers. After performing a laboratory work-up 2 to 4 weeks before surgery, preoperative iron supplementation in case of iron deficiency anemia at least 7 days before surgery was recommended. Preoperative anemia was defined by a Hb level < 13 g/dL for both sexes. In anemic patients, iron status study was recommended and iron supplementation with intravenous iron was indicated if Hb<12g/dL and/or ferritin <300 mg/l. Intravenous iron (ferric sucrose or carboxymaltose) was administrated with the goal of recovering iron deficit, calculated using the Ganzoni formula or by the simplified strategy, only available for ferric carboxymaltose. Recommended transfusion triggers were: Hb < 9 g/dL for patients with risk factors and/or anemia symptoms; and Hb < 7 g/dL for the rest of patients in absence of active bleeding.

After consensus, the upPBM was introduced through specific workshops to the members of the local multidisciplinary team from all participating hospitals by the two principal investigators of this study, and approval was obtained from each Institutional Review Board. Start of application of upPBM was prospectively communicated to the principal investigator of the study by the reference surgeon in each center.

The aim of this study is to evaluate the implementation and efficacy of a PBM protocol on perioperative RBCT and postoperative outcomes for patients undergoing gastric cancer resection with curative intent.

This is a multicenter retrospective study on a prospective cohort of consecutive patients undergoing elective gastric cancer resection with curative intent between January 2014 and December 2018 in hospitals of the Spanish EURECCA project which implemented the upPBM before December 31th, 2017, to ensure a minimum 1-year follow-up. Patients are divided in 2 groups: those with a diagnosis of gastric cancer before the upPBM implementation in their attending center and those with a diagnosis afterwards.