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

Not yet recruiting

• Conditions: Infective Endocarditis

• Registration Number: NCT06583902
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing improvement in anemia and reduction of transfusion support in the study population	18 months	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).