Patient Blood Management in Cardiac Surgery

Surgical Blood Loss Clinical Trial

— PBMc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040023
• Other study ID #: 2019-A01522-55
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: September 23, 2021

Study information

• Verified date: September 2021
• Source: Clinique Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 23, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Surgical Blood Loss

Intervention

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

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.

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse cedex 3

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBC transfusion rate	Proportion of patient who received at least one RBC transfusion during their hospitalization	Between surgery and hospital discharge, an average of 10 days
Secondary	Adverse events	Occurrence of adverse event	between baseline (1 month before surgery) and 3 months after surgery
Secondary	Transfusion parameters	Transfusion rate, use of poly transfusion, hemodilution, transfusion thresholds and postoperative bleeding volume.	between surgery and hospital discharge, an average of 10 days
Secondary	Blood test parameters	hemoglobin, ferritin	between baseline (1 month before surgery) and 3 months after surgery
Secondary	6 min walk test	Walking test : distance reach after 6 min	at discharge of the healthcare and rehabilitation units
Secondary	New York Heart Association (NYHA)	NYHA Functional Classification	between baseline (1 month before surgery) and 3 months after surgery
Secondary	Euro Quality of life 5 dimensions (EQ5D)	EQ5D Quality of life questionnaire	between baseline (1 month before surgery) and 3 months after surgery