Patient Blood Management in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)

Conditions
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Surgical Blood Loss

Intervention / Treatment
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* Drug: Iron and vitamin Deficiencies Correction Program
* Other: PBMi: Training program to improve transfusion practices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for cardiac surgery under ECC Patient affiliated or beneficiary of a social security scheme Patient having given his consent Exclusion Criteria: Urgent surgery (less than 48h) Contraindication to iron injection : proven allergic reaction Erythropoietin allergy Protected patients: Majors under some form of guardianship or other legal protection; pregnant, breastfeeding or parturient woman.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective monocentric superiority study in two successive steps
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I Group: PBMi<br>Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices | Other: PBMi: Training program to improve transfusion practices<br>* 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.<br>|
| Experimental: C Group: PBMc<br>Patient Blood Management: full program PBMi intervention and Drug intervention (systematic correction of pre- and postoperative iron and vitamin deficiencies, and erythropoietin preoperative treatment for anemic patient) | Drug: Iron and vitamin Deficiencies Correction Program<br>* 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<br>Other: PBMi: Training program to improve transfusion practices<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC transfusion rate | Proportion of patient who received at least one RBC transfusion during their hospitalization | Between surgery and hospital discharge, an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Occurrence of adverse event | between baseline (1 month before surgery) and 3 months after surgery | 
| Transfusion parameters | Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume. | between surgery and hospital discharge, an average of 10 days | 
| Blood test parameters | hemoglobin, ferritin | between baseline (1 month before surgery) and 3 months after surgery | 
| 6 min walk test | Walking test : distance reach after 6 min | at discharge of the healthcare and rehabilitation units | 
| New York Heart Association (NYHA) | NYHA Functional Classification | between baseline (1 month before surgery) and 3 months after surgery | 
| Euro Quality of life 5 dimensions (EQ5D) | EQ5D Quality of life questionnaire | between baseline (1 month before surgery) and 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery