Patient Blood Management in Cardiac Surgery
- Conditions
- Surgical Blood Loss
- Interventions
- Registration Number
- NCT04040023
- Lead Sponsor
- Clinique Pasteur
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- Patient scheduled for cardiac surgery under ECC
- Patient affiliated or beneficiary of a social security scheme
- Patient having given his consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description C Group: PBMc Iron and vitamin Deficiencies Correction Program 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)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Clinique Pasteur
🇫🇷Toulouse cedex 3, France