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NCT Number: NCT06583902

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

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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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive

Roma, 00168, Italy

Location contact

Giancarlo Scoppettuolo

CONTACT

[email protected]

+390630154945

Giancarlo Scoppettuolo

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous iron

Drug

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.

Other names: erythropoietin

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)

Primary outcomes

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

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Giancarlo Scoppettuolo, Dr

CONTACT

[email protected]

+ 390630154945

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: AMERICA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 4, 2024
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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