Clinical trial NCT04040023: Patient Blood Management in Cardiac Surgery
Official title: Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Blood Loss
Keywords: Red Blood Cell transfusion
Anemia
Iron deficiency
Extracorporeal circulation or Bypass
Cardiac Surgery
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective monocentric superiority study in two successive steps
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: RBC transfusion rate
timeFrame: Between surgery and hospital discharge, an average of 10 days
Secondary outcomes:
measure: Adverse events
timeFrame: between baseline (1 month before surgery) and 3 months after surgery
measure: Transfusion parameters
timeFrame: between surgery and hospital discharge, an average of 10 days
measure: Blood test parameters
timeFrame: between baseline (1 month before surgery) and 3 months after surgery
measure: 6 min walk test
timeFrame: at discharge of the healthcare and rehabilitation units
measure: New York Heart Association (NYHA)
timeFrame: between baseline (1 month before surgery) and 3 months after surgery
measure: Euro Quality of life 5 dimensions (EQ5D)
timeFrame: between baseline (1 month before surgery) and 3 months after surgery
Other outcomes:
Locations:
city: Toulouse cedex 3
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Hélène Charbonneau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.