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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • 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.

  • Retrospective case-control analysis

    Other intervention

    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)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: prospective1 intervention
Group B: Retrospective1 intervention

Trial outcomes

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).

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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