Surgical Blood Loss
Conditions
Keywords
Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery
Brief summary
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.
Interventions
DRUGIron and vitamin Deficiencies Correction Program
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
OTHERPBMi: Training program to improve transfusion practices
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.
Sponsors
Clinique Pasteur
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective monocentric superiority study in two successive steps
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC transfusion rate | Between surgery and hospital discharge, an average of 10 days | Proportion of patient who received at least one RBC transfusion during their hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | between baseline (1 month before surgery) and 3 months after surgery | Occurrence of adverse event |
| Transfusion parameters | between surgery and hospital discharge, an average of 10 days | Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume. |
| Blood test parameters | between baseline (1 month before surgery) and 3 months after surgery | hemoglobin, ferritin |
| 6 min walk test | at discharge of the healthcare and rehabilitation units | Walking test : distance reach after 6 min |
| New York Heart Association (NYHA) | between baseline (1 month before surgery) and 3 months after surgery | NYHA Functional Classification |
| Euro Quality of life 5 dimensions (EQ5D) | between baseline (1 month before surgery) and 3 months after surgery | EQ5D Quality of life questionnaire |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHélène Charbonneau, MD, PhD
Clinique Pasteur
Outcome results
None listed