Iron Deficiency in cardiac surgery

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Patients Undergoing Cardiac Surgery A Randomized Controlled Study - IDECAS RCT 3.0

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001823-26-IT

Enrollment

Registered

2021-06-08

Start date

2017-12-12

Completion date

Unknown

Last updated

2021-08-24

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

Conditions

Iron deficiency in cardiac surgery MedDRA version: 20.0 Level: LLT Classification code 10067709 Term: Hypoferrism System Organ Class: 100000004861

Interventions

Trade Name: FERINJECT - 50 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO IN VETRO DA 20 ML Product Name: Ferinject Product Code: 40251074 Pharmaceutical Form: Concentrate for solution for i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: LVEF = 40% • Ferritin 18 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Subject with sensitivity to intravenous iron 2. History of acquired iron overload 3. Known active bacterial infection 4. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal rang 5. WOCBP 6. Hypersensitivity to any of its excipients listed in IMP (section 6.1) 5. Clinical evidence of current malignancy 6. Currently receiving systemic chemotherapy and/or radiotherapy 7. Renal dialysis

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement of cardiac function;Secondary Objective: -LVEF, LV,diameters, LAVI, LVMI, E/e¿ - Change in exercise capacity(METs) - Lenght of stay (LOS) - Blood trasfusion;Primary end point(s): Change in Echo PSSR;Timepoint(s) of evaluation of this end point: 25 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): Echo GLS ¿ LVEF, LV diameters, LAVI, LVMI, E/ e¿ ¿ Change in exercise capacity(METs) ¿ Lenght of stay (LOS) ¿ Blood trasfusion;Timepoint(s) of evaluation of this end point: 25 weeks	—

Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni Cliniche

Universita Campus Bio-Medico Di Roma

manuela.greco@unicampus.it06225418874

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026