Surgical Blood LossPBMcNCT04040023
Patient Blood Management in Cardiac Surgery
A study testing Iron and vitamin Deficiencies Correction Program and PBMi: Training program to improve transfusion practices in people with Surgical Blood Loss, run by Clinique Pasteur at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Blood Loss
- What is being tested?
- Iron and vitamin Deficiencies Correction Program and PBMi: Training program to improve transfusion practices
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2019to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for cardiac surgery under ECC
- Patient affiliated or beneficiary of a social security scheme
- Patient having given his consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Iron and vitamin Deficiencies Correction Program, PBMi: Training program to improve transfusion practices
- Keywords
- Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery
- Medical subject headings
- Blood Loss, Surgical, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron and vitamin Deficiencies Correction ProgramDrug
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 practicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I Group: PBMi | Other | Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices Receives: 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) Receives: Drug: Iron and vitamin Deficiencies Correction Program; Other: PBMi: Training program to improve transfusion practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC transfusion rate
Proportion of patient who received at least one RBC transfusion during their hospitalization
Measured: Between surgery and hospital discharge, an average of 10 days
Secondary outcomes (6)
Adverse events
Occurrence of adverse event
Measured: between baseline (1 month before surgery) and 3 months after surgery
Transfusion parameters
Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.
Measured: between surgery and hospital discharge, an average of 10 days
Blood test parameters
hemoglobin, ferritin
Measured: between baseline (1 month before surgery) and 3 months after surgery
6 min walk test
Walking test : distance reach after 6 min
Measured: at discharge of the healthcare and rehabilitation units
New York Heart Association (NYHA)
NYHA Functional Classification
Measured: between baseline (1 month before surgery) and 3 months after surgery
Euro Quality of life 5 dimensions (EQ5D)
EQ5D Quality of life questionnaire
Measured: between baseline (1 month before surgery) and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start10 Sep 2019
- Primary completion24 Jul 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective monocentric superiority study in two successive steps
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Charbonneau, MD, PhD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040023
- Sponsor's protocol ID
- 2019-A01522-55
- Acronym
- PBMc
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39146724Charbonneau 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.
PubMed 41483954Charbonneau 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.
PubMed 32695923
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)
- ClinicalTrials.gov ID
- NCT04040023
- Acronym / sponsor ID
- PBMc / 2019-A01522-55
- Conditions
- Surgical Blood Loss
- Keywords
- Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective monocentric superiority study in two successive steps
| Arm | Type | Receives |
|---|---|---|
| I Group: PBMi | Other | Other: PBMi: Training program to improve transfusion practicesNon-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices |
| C Group: PBMc | Experimental | Drug: Iron and vitamin Deficiencies Correction Program, Other: PBMi: Training program to improve transfusion practicesPatient 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for cardiac surgery under ECC
- Patient affiliated or beneficiary of a social security scheme
- Patient having given his consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron and vitamin Deficiencies Correction ProgramPreoperative: 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 | Drug | C Group: PBMc |
| PBMi: Training program to improve transfusion practicesTraining 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. | Other | C Group: PBMc, I Group: PBMi |
Primary outcome
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
6 secondary outcomes
Adverse events
Time frame: 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
Blood test parameters
Time frame: 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
New York Heart Association (NYHA)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 39146724Charbonneau 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.
- Derived from this study: PubMed 41483954Charbonneau 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.
- Derived from this study: PubMed 32695923Charbonneau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Charbonneau, MD, PhD principal investigator
Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron and vitamin Deficiencies Correction Program and PBMi: Training program to improve transfusion practices in people with Surgical Blood Loss, run by Clinique Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC transfusion rate (time frame: Between surgery and hospital discharge, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04040023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.