Clinical trial NCT06637137: Patient Blood Management in Patients Scheduled for Cardiac Surgery
Official title: Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anemia
Anemia, Iron-Deficiency
Iron Deficiency Anemia Treatment
Iron Deficiency Anemia (IDA)
Cardiac Surgical Patients
Blood Loss, Surgical
Keywords: iron
anemia
cardiac surgery
patient blood management
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

- all adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

* pregnancy
* dyalisis
* patient's refusal

Primary outcomes:
measure: Percentage of patients receiving RBC transfusion within post-operative day 7
timeFrame: within post operative day 7
Secondary outcomes:
measure: cost measured in euros for the IDA treatment and blood product consumption
timeFrame: from enrollment to 1 week after surgery
measure: Hb values at last postoperative control within 7 days from surgery
timeFrame: within post operative day 7
measure: ICU lenght of stay
timeFrame: through study completion, an average of 2 year
measure: Number of allogenic blood products administered
timeFrame: within the first 7 days post operative
measure: mortality
timeFrame: from surgery within post operative day 7
measure: Hospital Lenght of Stay
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli, IRCCS
name: luciana Teofili, Phd
role: STUDY_DIRECTOR
References:
citation: Corsi F, Pasquini A, Guerrera M, Bevilacqua F, Taccheri T, Antoniucci ME, Calabrese M, Valentini CG, Orlando N, Bartolo M, Cannetti G, Pellegrino C, Cavaliere F, Teofili L. Single shot of intravenous iron in cardiac surgery: The ICARUS study. J Clin Anesth. 2023 Feb;84:111009. doi: 10.1016/j.jclinane.2022.111009. Epub 2022 Nov 16.