Patient Blood Management in Cardiac Surgery (PBMc)

Clinique Pasteur

Status: Completed

Conditions: Surgical Blood Loss

Treatments: Other: PBMi: Training program to improve transfusion practices; Drug: Iron and vitamin Deficiencies Correction Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04040023

2019-A01522-55

Details and patient eligibility

About

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.

Enrollment: 900 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

I Group: PBMi

Other group

Description:

Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices

Treatment:

Other: PBMi: Training program to improve transfusion practices

C Group: PBMc

Experimental group

Description:

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)

Treatment:

Other: PBMi: Training program to improve transfusion practices

Drug: Iron and vitamin Deficiencies Correction Program