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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04040023
Other study ID # 2019-A01522-55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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