Patient Blood Management In CARdiac sUrgical patientS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study

Conditions
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Anemia, Blood Loss Anemia, Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment, Erythropoiesis Abnormal

Intervention / Treatment
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* Drug: Ferric carboxymaltose
* Drug: B vitamin
* Drug: Folic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>patients who fulfill the inclusion criteria | Drug: Ferric carboxymaltose<br>* administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria<br>* Other names: ferinject;Drug: B vitamin<br>* administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria<br>Drug: Folic acid<br>* administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria<br>|
| controls<br>Patients who underwent cardiac surgery in 2019 and 2018 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving RBC transfusion within post-operative day 7 | Percentage of patients receiving RBC transfusion within post-operative day 7 | within post operative day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb values at last postoperative control within 7 days from surgery | Hb values at last postoperative control within 7 days from surgery | within post operative day 7 | 
| length of stay in ICU | length of stay in ICU | through study completion, an average of 1 year | 
| number of allogeneic blood products administered | number of allogeneic blood products administered | within the first 7 days post operative | 
| duration of mechanical ventilation | duration of mechanical ventilation | within the first 7 days post operative | 
| acute kidney injury | worsening of renal function | within the first 7 days post operative | 
| serious adverse events | including hypersensitivity reactions | within the first 12 hours after administration | 
| infections requiring antibiotic treatment | infections requiring antibiotic treatment | within the first 7 days post operative | 
| mortality | patients died within the first 7 days after surgery | within the first 7 days after surgery | 
| major adverse cardiac and cerebrovascular events | cardiogenic shock, neurological events | within the first 7 days after surgery | 
| cost for the IDA/IDE treatment and blood product costs | cost for the IDA/IDE treatment and blood product costs | within the first 7 days after surgery |