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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cases | patients who fulfill the inclusion criteria |
| |
| controls | Patients who underwent cardiac surgery in 2019 and 2018, with an unknown iron status and never treated with iron supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria |
|
| 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 |
| 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 |
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Inclusion Criteria:
- all adult patients candidate to planned heart surgery
Exclusion Criteria:
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All adult patients candidate to planned heart surgery in our tertiary care hospital are eligible for the study purpose.
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| Name | Affiliation | Role |
|---|---|---|
| filippo corsi, Dr | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FPG Fondazione Policlinico Gemelli IRCCS | Roma | Roma | 00100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31036337 | Result | 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. | |
| 36401886 |
| Label | URL |
|---|---|
| Haemoglobin concentration for the diagnosis of anaemia and assesment of severity | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
IPD will be shared upon reasonable request to the PI and after approval by ethic committee.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D014803 | Vitamin B Complex |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| B vitamin | Drug | administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria |
|
| Folic acid | Drug | administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria |
|
| 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 |
| 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. |
| Perioperative Anemia Management as Part of PBM in Cardiac Surgery - A Narrative Updated Review | View source |
| The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery | View source |
| Does the severity of preoperative anemia or blood transfusion have a stronger impact on long-term survival after cardiac surgery? | View source |
| Impact of Preoperative Iron Deficiency on Blood Transfusion in Elective Cardiac Surgery | View source |
| Iron deficiency impairs contractility of human cardiomyocytes through decreased mitochondrial function | View source |
| Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial | View source |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020164 |
| Chemical Actions and Uses |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |