Patient Blood Management in Cardiac Surgery

NCT ID: NCT04040023

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-09-23

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

I Group: PBMi

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

Group Type: OTHER

PBMi: Training program to improve transfusion practices

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

Iron and vitamin Deficiencies Correction Program

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Pasteur

OTHER

Sponsor Role: lead

Responsible Party

Dr Hélène Charbonneau

Principal investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hélène Charbonneau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur

Locations

Clinique Pasteur

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32695923 (View on PubMed)

Other Identifiers

2019-A01522-55

Identifier Type: -

Identifier Source: org_study_id