An observational study in Infective Endocarditis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 100 is below the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted to the Foundation for infective endocarditis with an indication for cardiac surgery presenting anaemia.
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 (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 trials; Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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