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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I Group: PBMi | Other | Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices |
|
| C Group: PBMc | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron and vitamin Deficiencies Correction Program | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène Charbonneau, MD, PhD | Clinique Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Toulouse | 31076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146724 | Result | Charbonneau H, Savy S, Savy N, Pasquie M, Mayeur N; CP-PBM Study Group; Angles O, Balech V, Berthelot AL, Croute-Bayle M, Decramer I, Duterque D, Julien V, Mallet L, M'rini M, Quedreux JF, Richard B, Sidobre L, Taillefer L, Thibaud A, Abouliatim I, Berthoumieu P, Garcia O, Soula P, Vahdat O, Breil C, Brunel P, Sciacca G. Comprehensive perioperative blood management in patients undergoing elective bypass cardiac surgery: Benefit effect of health care education and systematic correction of iron deficiency and anemia on red blood cell transfusion. J Clin Anesth. 2024 Nov;98:111560. doi: 10.1016/j.jclinane.2024.111560. Epub 2024 Aug 14. | |
| 41483954 |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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Prospective monocentric superiority study in two successive steps
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|
| PBMi: Training program to improve transfusion practices | Other | 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. |
|
| 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 |
| Derived |
| Charbonneau H, Pasquie M, Savy N, Mayeur N. Hemoglobin Optimization and Transfusion Reduction Through Anemia and Iron Deficiency Correction: A Post Hoc Prospective Study in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2026 Mar;40(3):825-835. doi: 10.1053/j.jvca.2025.11.028. Epub 2025 Nov 24. |
| 32695923 | Derived | Charbonneau H, Pasquie M, Berthoumieu P, Savy N, Autones G, Angles O, Berthelot AL, Croute-Bayle M, Decramer I, Duterque D, Gabiache Y, Julien V, Mallet L, M'rini M, Quedreux JF, Richard B, Sidobre L, Taillefer L, Soula P, Garcia O, Abouliatim I, Vahdat O, Bousquet M, Ferradou JM, Jansou Y, Brunel P, Breil C, Mayeur N. 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. Contemp Clin Trials Commun. 2020 Jul 15;19:100617. doi: 10.1016/j.conctc.2020.100617. eCollection 2020 Sep. |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008670 |
| Metals |