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

NCT06583902 — Unknown, 100 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Management of Anaemia in Patients with Infectious Endocarditis Who Are Candidates for Cardiac Surgery: the AMERICA Trial

Registry	NCT06583902, acronym AMERICA
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Conditions	Infective Endocarditis
Interventions	Intravenous iron, Retrospective case-control analysis (Drug, other)
Dates	start 2024-10-01 (estimated), primary completion 2025-10-01 (estimated), completion 2025-10-30 (estimated), first posted 2024-09-04, last updated 2024-09-04
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
prospective		Drug: Intravenous iron	Data obtained in patients prospectively included in the study will be compared with those from a retrospective case-control population of patients treated consecutively in the previous two years.
Retrospective		Other: Retrospective case-control analysis	Data obtained in patients prospectively included in the study will be compared with those from a retrospective case-control population of patients treated consecutively in the previous two years.

Intravenous iron (Drug), also known as erythropoietin: 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.
Retrospective case-control analysis (Other): the only routine clinical data collection (Hb, iron status, direct and indirect Coombs test, IL6, erythropoietin dosage, number of units of blood components possibly transfused)

+Outcome measures

Primary outcomes

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).

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive	Roma, Roma	Italy