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Contemporary clinical trials communications · 2020

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.

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

Аннотация

UNLABELLED: 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 REGISTRATIONS: ClinicalTrials.gov, NCT04040023: registered 29 July 2019.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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