About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
pregnancy
dyalisis
patient's refusal
Trial population
All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.
Trial design
Case-control
Prospective
Treatments tested in this trial
Iron
DrugPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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).
Hb values at last postoperative control within 7 days from surgery
Hb values at last postoperative control within 7 days from surgery
ICU lenght of stay
lenght of stay in ICU
Number of allogenic blood products administered
Number of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
Sponsors and contacts
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