Patient Blood Management in Cardiac Surgery

NCT04040023 | Completed

• 1 other identifier: 2019-A01522-55
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Blood Loss

Keywords

Red Blood Cell transfusion; Anemia; Iron deficiency; Extracorporeal circulation or Bypass; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Adverse events

  between baseline (1 month before surgery) and 3 months after surgery

• Transfusion parameters

  between surgery and hospital discharge, an average of 10 days

• Blood test parameters

  between baseline (1 month before surgery) and 3 months after surgery

• 6 min walk test

  at discharge of the healthcare and rehabilitation units

• New York Heart Association (NYHA)

  between baseline (1 month before surgery) and 3 months after surgery

Study Arms (2)

I Group: PBMi

OTHER

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

Other: PBMi: Training program 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)

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

Interventions

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

C Group: PBMc

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.

C Group: PBMc; I Group: PBMi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for cardiac surgery under ECC
• Patient affiliated or beneficiary of a social security scheme
• Patient having given his consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (3)

• 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.

  PMID: 39146724 RESULT

• 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.

  PMID: 41483954 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.

  PMID: 32695923 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Anemia; Iron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hélène Charbonneau, MD, PhD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric superiority study in two successive steps

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 31, 2019
• Study Start: September 10, 2019
• Primary Completion: July 24, 2021
• Study Completion: September 23, 2021
• Last Updated: March 6, 2026

Record last verified: 2021-09

Locations

FR (1)