Clinical trial NCT04744181: Patient Blood Management In CARdiac sUrgical patientS
Official title: Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Blood Loss Anemia
Iron-deficiency
Iron Deficiency Anemia
Iron Deficiency Anemia Treatment
Erythropoiesis Abnormal
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 479
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 adult patients candidate to planned heart surgery in our tertiary care hospital are eligible for the study purpose.

Brief summary: Nowadays up to 40% of patients undergoing cardiac surgery receives at least 1 unit of red blood cell transfusion during surgery or during the first week after surgery. Moreover up to 40% of these patients shows an absolute or relative iron deficiency, with or without anaemia.

The objective of this study is to assess whether to implement an adequate correction of iron according to current "patients blood management" recommendations might reduce RBC transfusion requirements in patients undergoing heart surgery.

Data obtained in patients included in the study will be compared to those of a case-control population selected from patients consecutively treated at the same department in the previous 2 years.

Detailed description: Anemia is defined by the World Health Organization (WHO) as a value of hemoglobin (Hb) \< 130 g/L in men and \< 120 g/L in women. Anemia in surgical patients is a common and serious problem, in fact up to 40% of patients presenting for major surgery are anemic. Patients with pre-operative anemia have significantly higher rates of morbidity and mortality and are likely to receive red blood cell (RBC) transfusions. In turn, RBC are independently associated with worse outcome. Preoperative anemia mainly results from inadequate erythropoiesis owing to iron deficiency. Iron deficiency anemia (IDA) has a complex origin, including either absolute or functional iron deficiency (or iron sequestration). In absolute iron deficiency, iron stores are severely decreased, resulting in anaemia (IDA). Conversely, functional iron deficiency refers to insufficient iron mobilization despite normal or elevated iron stores (iron deficient erythropoiesis, IDE).The most rapid and simple method to correct anaemia is RBC transfusion. More than 30% of cardiac patients receives blood products in the peri-operative phase. However, blood transfusion itself is not without risk: in the setting of cardiac patients, even a single unit of blood transfused is reported to be associated to increased morbidity and mortality. Specifically, blood transfusions in cardiac surgery are associated with infections, ischemic postoperative morbidity, hospital stay, increased early and late mortality, and greater hospital costs. Preoperative correction of iron deficiency, with or without anaemia, is an integral part of the concept of the Patient Blood Management (PBM). Iron supplementation would increase the availability of iron stores and would trigger the process of erythropoiesis; the consequent relative lack of vitamin B12 and folic acid makes fundamental to restore also these 2 vitamins.

The objective of this study is to assess whether to implement an adequate correction of IDA and IDE according to current PBM recommendations might reduce RBC transfusion requirements in patients undergoing heart surgery. Data obtained in patients included in the study will be compared to those of a case-control population selected from patients consecutively treated at the same department in the previous 2 years.

Eligibility criteria: Inclusion Criteria:

- all adult patients candidate to planned heart surgery

Exclusion Criteria:

* Pregnancy
* Know allergy to iron, or B vitamin, or folic acid
* Hyperferritinemia (ferritin blood value \> 300 ng/ml).
* 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: Hb values at last postoperative control within 7 days from surgery
timeFrame: within post operative day 7
measure: length of stay in ICU
timeFrame: through study completion, an average of 1 year
measure: number of allogeneic blood products administered
timeFrame: within the first 7 days post operative
measure: duration of mechanical ventilation
timeFrame: within the first 7 days post operative
measure: acute kidney injury
timeFrame: within the first 7 days post operative
measure: serious adverse events
timeFrame: within the first 12 hours after administration
measure: infections requiring antibiotic treatment
timeFrame: within the first 7 days post operative
measure: mortality
timeFrame: within the first 7 days after surgery
measure: major adverse cardiac and cerebrovascular events
timeFrame: within the first 7 days after surgery
measure: cost for the IDA/IDE treatment and blood product costs
timeFrame: within the first 7 days after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: FPG Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: filippo corsi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.
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.