Clinique Pasteur
Toulouse, 31076, France
NCT Number: NCT04040023
Preoperative anemia is associated with an important increase in transfusions of red blood cells (RBC) compared to a non-anemic patient in cardiac and non cardiac surgery. Furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Cardiac Overload (TACO), and an increase in mortality of 16%.
Management of perioperative transfusion is therefore a public health issue. Since 2010, the World Health Organization (WHO) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care.
Improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis:
A:non-drug intervention : Review of Practices to Improve the Management of Perioperative RBC Transfusion
B:drug intervention : Systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia
The aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. This program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ECC). It requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toulouse, 31076, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative:
For patient with iron deficiency: Intravenous iron supplementation For patient with folic acid or vitamin B12 deficiency : oral vitamin supplementation For patient with anemia: pre operative erythropoietin injections
Postoperative:
Systematic iron supplementation
Training program to sensitize health care staff to streamline the use of transfusion targeting the following points: limit perioperative and post operative hemodilution; to adapt the transfusion threshold to the tolerance of the patient to anemia in per and postoperative; justify the use of RBC transfusion by setting up a questionnaire; encourage transfusion of RBC unit by unit.
Time frame: Between surgery and hospital discharge, an average of 10 days
Proportion of patient who received at least one RBC transfusion during their hospitalization
Time frame: between baseline (1 month before surgery) and 3 months after surgery
Occurrence of adverse event
Time frame: between surgery and hospital discharge, an average of 10 days
Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.
Time frame: between baseline (1 month before surgery) and 3 months after surgery
hemoglobin, ferritin
Time frame: at discharge of the healthcare and rehabilitation units
Walking test : distance reach after 6 min
Time frame: between baseline (1 month before surgery) and 3 months after surgery
NYHA Functional Classification
Time frame: between baseline (1 month before surgery) and 3 months after surgery
EQ5D Quality of life questionnaire
Clinique Pasteur
Other
Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)
Acronym: PBMc
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