Patient Blood Management in Patients Scheduled for Cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Iron

    Drug

    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.

Treatment groups

464 Participants
are divided into 3 treatment groups
Group A: Prospectic cohort1 intervention
Group B: retrospective cohort ICARUS 10 interventions
Group C: retrospective cohort0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

ICU lenght of stay

lenght of stay in ICU

Time frame
through study completion, an average of 2 year
4

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

Other outcomes

Sponsors and contacts

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