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OpenTrials
Completed

NCT Number: NCT04040023

Patient Blood Management in Cardiac Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events

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

    Occurrence of adverse event

  2. 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.

  3. Blood test parameters

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

    hemoglobin, ferritin

  4. 6 min walk test

    Time frame: at discharge of the healthcare and rehabilitation units

    Walking test : distance reach after 6 min

  5. New York Heart Association (NYHA)

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

    NYHA Functional Classification

  6. 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

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study title

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

Acronym: PBMc

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2019
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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