An observational study in Anemia, Anemia, Iron-Deficiency and Iron Deficiency Anemia Treatment, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation.
In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.
A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention.
The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 464 is above the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Compared within Anemia, Iron-Deficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- all adult patients scheduled for elective cardiac surgery
Exclusion Criteria:
patients scheduled for cardiac surgery who fulfil the inclusion criteria
Drug: Iron
patients scheduled for cardiac surgery (2021) with a known iron status, treated if indicated 1 or 2 days before surgery with iron supplementation.
patients scheduled for cardiac surgery (2019-2020)with an unknown iron status and never treated with iron supplementation
Patients who present a state of hypoferritinemia or a state of reduced transferrin saturation will undergo administration of i.v iron at least 2 weeks before scheduled cardiac surgery, plus acid folic and B vitamin co-administration.
Also known as: folic acid, b vitamin
Percentage of patients receiving RBC transfusion within post-operative day 7
number of RBC units transfused from the operating room till post operative day 7
Time frame: within post operative day 7
cost measured in euros for the IDA treatment and blood product consumption
We will assess if ID screening and iron replacement is cost-effective, considering the costs, expressed in euros, of the treatment with ferric carboxymaltose, folic acid and B12 vitamin, the pRBC consumption and hospitalization (either in ICU or in the regular ward).
Time frame: from enrollment to 1 week after surgery
Hb values at last postoperative control within 7 days from surgery
Hb values at last postoperative control within 7 days from surgery
Time frame: within post operative day 7
ICU lenght of stay
lenght of stay in ICU
Time frame: through study completion, an average of 2 year
Number of allogenic blood products administered
Number of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
Time frame: within the first 7 days post operative
mortality
patients died within the first 7 days after surgery
Time frame: from surgery within post operative day 7
Hospital Lenght of Stay
The number of days spent in the hospital
Time frame: through study completion, an average of 2 year
Plan to share: No — IPPD will be shared upon reasonable request to the PPI and after approval of ethic commitee.
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