Patient blood management in elective bypass cardiac surgery: A 2-step single-centre interventional trial to analyse the impact of an educational programme and erythropoiesis stimulation on red blood cell transfusion

Hélène Charbonneau,David Duterque,Pierre Brunel,Pierre Berthoumieu,Laurent Sidobre,Yannick Gabiache,Issam Abouliatim,Nicolas Savy,Mimoun M'Rini,Marc Bousquet,Olivier Garcia,Valérie Julien,Yves Jansou,Isabelle Decramer,Philippe Soula,Olivier Vahdat,Madeleine Croute-Bayle,Nicolas Mayeur,Gérard Autones,Laurent Mallet,Claude Breil,Olivier Anglès ,Anne Laure Berthelot ,Benoît Richard ,Jean Marc Ferradou ,M Pasquié ,Laurence Taillefer ,Jean François Quedreux

doi:10.1016/j.conctc.2020.100617

Abstract

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery.This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation.The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. Trials registrationsClinicalTrials.gov, NCT04040023: registered 29 July 2019.

Highlights

The prevalence of anaemia in patients scheduled for elective cardiac surgery is approximately 25% [1]
The aim of this study was to improve the relevance of red blood cell (RBC) trans fusion in cardiac surgery and to limit the morbidity and mortality induced by RBC transfusion
Group B Size: A sample of 320 patients is required to test the con formity of the transfusion rate of patients who received the patient blood management (PBM) com plete programme to the target value of 30.4% using a bilateral conformity test with a type I error risk of 5% and a power of 80% (corresponding to a 20% reduction in the transfusion rate compared to data observed in our institution in the first half of 2018 (38% of RBC transfusion during the length of stay)

Summary

Introduction

The prevalence of anaemia in patients scheduled for elective cardiac surgery is approximately 25% [1]. Anaemia has been reported to be an independent risk factor for red blood cell (RBC) transfusion and adverse clinical outcomes, including infections, atrial fibrillation, respiratory complications, acute kidney injury and short-to long-term mortality [2,3,4,5,6]. Numerous practice guidelines and consensus statements for perioperative patient blood management (PBM) have been proposed to reduce the risk of adverse outcomes associated with transfusions, bleeding, or anaemia [8,9,10]. The level of these recommendations is rather high despite a low level of publication on patient blood man agement in cardiac surgery. Research has revealed that adherence to these guidelines is poor, and as a result, a significant variability in pa tient transfusion practices among practitioners remains [9]

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