Patient Blood Management in Cardiac Surgery (PBMc)
Primary Purpose
Surgical Blood Loss
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Iron and vitamin Deficiencies Correction Program
PBMi: Training program to improve transfusion practices
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Blood Loss focused on measuring Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery
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.
Sites / Locations
- Clinique Pasteur
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
I Group: PBMi
C Group: PBMc
Arm Description
Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices
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)
Outcomes
Primary Outcome Measures
RBC transfusion rate
Proportion of patient who received at least one RBC transfusion during their hospitalization
Secondary Outcome Measures
Adverse events
Occurrence of adverse event
Transfusion parameters
Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.
Blood test parameters
hemoglobin, ferritin
6 min walk test
Walking test : distance reach after 6 min
New York Heart Association (NYHA)
NYHA Functional Classification
Euro Quality of life 5 dimensions (EQ5D)
EQ5D Quality of life questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04040023
Brief Title
Patient Blood Management in Cardiac Surgery
Acronym
PBMc
Official Title
Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
July 24, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Pasteur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Blood Loss
Keywords
Red Blood Cell transfusion, Anemia, Iron deficiency, Extracorporeal circulation or Bypass, Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective monocentric superiority study in two successive steps
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I Group: PBMi
Arm Type
Other
Arm Description
Non-drug intervention First part of PBM program (PBMi) Training part for medical care staff to improve transfusion practices
Arm Title
C Group: PBMc
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Iron and vitamin Deficiencies Correction Program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
PBMi: Training program to improve transfusion practices
Intervention Description
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 Outcome Measure Information:
Title
RBC transfusion rate
Description
Proportion of patient who received at least one RBC transfusion during their hospitalization
Time Frame
Between surgery and hospital discharge, an average of 10 days
Secondary Outcome Measure Information:
Title
Adverse events
Description
Occurrence of adverse event
Time Frame
between baseline (1 month before surgery) and 3 months after surgery
Title
Transfusion parameters
Description
Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.
Time Frame
between surgery and hospital discharge, an average of 10 days
Title
Blood test parameters
Description
hemoglobin, ferritin
Time Frame
between baseline (1 month before surgery) and 3 months after surgery
Title
6 min walk test
Description
Walking test : distance reach after 6 min
Time Frame
at discharge of the healthcare and rehabilitation units
Title
New York Heart Association (NYHA)
Description
NYHA Functional Classification
Time Frame
between baseline (1 month before surgery) and 3 months after surgery
Title
Euro Quality of life 5 dimensions (EQ5D)
Description
EQ5D Quality of life questionnaire
Time Frame
between baseline (1 month before surgery) and 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Charbonneau, MD, PhD
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Pasteur
City
Toulouse cedex 3
ZIP/Postal Code
31076
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32695923
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.
Results Reference
derived
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Patient Blood Management in Cardiac Surgery
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