FPG Fondazione Policlinico Gemelli IRCCS
Roma, 00100, Italy
NCT Number: NCT04744181
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.
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Notify Me18 year and older
All sexes
Observational
Roma, 00100, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria
Other names: ferinject
administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria
administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria
Time frame: within post operative day 7
Percentage of patients receiving RBC transfusion within post-operative day 7
Time frame: within post operative day 7
Hb values at last postoperative control within 7 days from surgery
Time frame: through study completion, an average of 1 year
length of stay in ICU
Time frame: within the first 7 days post operative
number of allogeneic blood products administered
Time frame: within the first 7 days post operative
duration of mechanical ventilation
Time frame: within the first 7 days post operative
worsening of renal function
Time frame: within the first 12 hours after administration
including hypersensitivity reactions
Time frame: within the first 7 days post operative
infections requiring antibiotic treatment
Time frame: within the first 7 days after surgery
patients died within the first 7 days after surgery
Time frame: within the first 7 days after surgery
cardiogenic shock, neurological events
Time frame: within the first 7 days after surgery
cost for the IDA/IDE treatment and blood product costs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study
Acronym: ICARUS
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