Management of Anemia in Patients with EndocaRditis Infectious Candidates for Cardiac Surgery: the AMERICA Study

N/ANot Yet RecruitingNCT06583902

Fondazione Policlinico Universitario Agostino Gemelli IRCCS100 enrolled

Overview

Infective endocarditis (EI) is an extremely serious disease requiring prolonged hospitalisation, complex management by multidisciplinary teams and high healthcare costs. Anemia is also emerging as a virtually constant condition associated with endocarditis, as evidenced by its inclusion in the variables used to calculate risk scores.Anemia associated with infective endocarditis (EI) has a remarkably complex and multifactorial pathogenesis.It is essential to treat anaemia in patients with EI as an integral part of their overall therapy, in what is now called patient blood management. Blood transfusion is not the only approach available to treat this condition. It is essential to correct any deficiencies, whether iron or vitamins. In addition, some patients may benefit from the administration of erythropoiesis-stimulating agents.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Infective Endocarditis

Interventions

Intravenous ironDRUG

Patients with an absolute deficiency (ferritin ≤100 μg/L) or functional deficiency (ferritin ≤ 300 μg/L with transferrin saturation ≤20%) receive iron supplementation, through a single administration of an iron preparation for intravenous use administered according to the doses present in the technical data sheet.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients with endocarditis who are candidates for elective surgery; Male and female patients aged \> 18 years; Patients who have given written consent to participate in the study and to have their clinical data processed for the purposes of the study. Exclusion Criteria: Age \< 18 years; Patients with hypersensitivity (bronchial asthma, urticaria, allergic phenomena) to preparations of intravenous iron, folic acid, vitamin B12, erythropoietin; Patients who have not given written consent to participate in the study and who have specifically refused the use of their clinical data for the purposes of the study; Patients participating in other investigational trials; Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for the study

Outcomes

Primary Outcomes

Assessing improvement in anemia and reduction of transfusion support in the study population

To assess the improvement in anaemia and reduction in transfusion support in the study population compared to a selected control population (patients with endocarditis who underwent surgery in the 24 months prior to PBM implementation).

Time frame: 18 months