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

NCT06583902 | Not Yet Recruiting

• 1 other identifier: ID 6780
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

• 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).

  18 months

Study Arms (2)

prospective

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.

Drug: Intravenous iron

Retrospective

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.

Other: Retrospective case-control analysis

Interventions

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.

Also known as: erythropoietin

prospective

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)

Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the Foundation for infective endocarditis with an indication for cardiac surgery presenting anaemia.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Endocarditis

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Giancarlo Scoppettuolo, Dr

CONTACT

+ 390630154945; giancarlo.scoppettuolo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 30, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)