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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06583902
Acronym
AMERICA
Enrollment
100
Registered
2024-09-04
Start date
2024-10-31
Completion date
2025-10-30
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis

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.

Interventions

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.

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)

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessing improvement in anemia and reduction of transfusion support in the study population18 monthsTo 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).

Countries

Italy

Contacts

Primary ContactGiancarlo Scoppettuolo, Dr
giancarlo.scoppettuolo@policlinicogemelli.it+ 390630154945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026