Patient Blood Management in Cardiac Surgery (PBMc)

March 5, 2026 updated by: Clinique Pasteur

Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31076
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: I Group: PBMi
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
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.
Experimental: C Group: PBMc

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)
Other: PBMi: 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.
Drug: Iron 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBC transfusion rate
Time Frame: Between surgery and hospital discharge, an average of 10 days
Proportion of patient who received at least one RBC transfusion during their hospitalization
Between surgery and hospital discharge, an average of 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: between baseline (1 month before surgery) and 3 months after surgery
Occurrence of adverse event
between baseline (1 month before surgery) and 3 months after surgery
Transfusion parameters
Time Frame: between surgery and hospital discharge, an average of 10 days
Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.
between surgery and hospital discharge, an average of 10 days
Blood test parameters
Time Frame: between baseline (1 month before surgery) and 3 months after surgery
hemoglobin, ferritin
between baseline (1 month before surgery) and 3 months after surgery
6 min walk test
Time Frame: at discharge of the healthcare and rehabilitation units
Walking test : distance reach after 6 min
at discharge of the healthcare and rehabilitation units
New York Heart Association (NYHA)
Time Frame: between baseline (1 month before surgery) and 3 months after surgery
NYHA Functional Classification
between baseline (1 month before surgery) and 3 months after surgery
Euro Quality of life 5 dimensions (EQ5D)
Time Frame: between baseline (1 month before surgery) and 3 months after surgery
EQ5D Quality of life questionnaire
between baseline (1 month before surgery) and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Pasteur

Investigators

  • Principal Investigator: Hélène Charbonneau, MD, PhD, Clinique Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

July 24, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01522-55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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