AnemiaICARUSNCT04744181
Patient Blood Management In CARdiac sUrgical patientS
An observational study of Anemia and Blood Loss Anemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Blood Loss Anemia, Iron-deficiency
- What is being tested?
- Ferric carboxymaltose, B vitamin and Folic acid
- How many people
- 479 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients candidate to planned heart surgery in our tertiary care hospital are eligible for the study purpose.
Who may be able to join
- all adult patients candidate to planned heart surgery
Who cannot join
- Pregnancy
- Know allergy to iron, or B vitamin, or folic acid
- Hyperferritinemia (ferritin blood value > 300 ng/ml).
- patient's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study
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.
Read the 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.
- Conditions
- Anemia, Blood Loss Anemia, Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment, Erythropoiesis Abnormal
- Being tested
- Ferric carboxymaltose, B vitamin, Folic acid
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called ferinject
administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria
B vitaminDrug
administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria
Folic acidDrug
administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| cases | patients who fulfill the inclusion criteria Receives: Drug: Ferric carboxymaltose; Drug: B vitamin; Drug: Folic acid | |
| controls | Patients who underwent cardiac surgery in 2019 and 2018, with an unknown iron status and never treated with iron supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving RBC transfusion within post-operative day 7
Percentage of patients receiving RBC transfusion within post-operative day 7
Measured: within post operative day 7
Secondary outcomes (10)
Hb values at last postoperative control within 7 days from surgery
Hb values at last postoperative control within 7 days from surgery
Measured: within post operative day 7
length of stay in ICU
length of stay in ICU
Measured: through study completion, an average of 1 year
number of allogeneic blood products administered
number of allogeneic blood products administered
Measured: within the first 7 days post operative
duration of mechanical ventilation
duration of mechanical ventilation
Measured: within the first 7 days post operative
acute kidney injury
worsening of renal function
Measured: within the first 7 days post operative
serious adverse events
including hypersensitivity reactions
Measured: within the first 12 hours after administration
infections requiring antibiotic treatment
infections requiring antibiotic treatment
Measured: within the first 7 days post operative
mortality
patients died within the first 7 days after surgery
Measured: within the first 7 days after surgery
major adverse cardiac and cerebrovascular events
cardiogenic shock, neurological events
Measured: 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
Measured: within the first 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Jan 2021
- Primary completion1 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORSI FILIPPO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- filippo corsi, Dr, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744181
- Sponsor's protocol ID
- 0047459/20
- Acronym
- ICARUS
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon reasonable request to the PI and after approval by ethic committee.
Publications
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.
PubMed 31036337Corsi 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.
PubMed 36401886
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study
- ClinicalTrials.gov ID
- NCT04744181
- Acronym / sponsor ID
- ICARUS / 0047459/20
- Conditions
- Anemia, Blood Loss Anemia, Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment, Erythropoiesis Abnormal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Drug: Ferric carboxymaltose, Drug: B vitamin, Drug: Folic acidpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients candidate to planned heart surgery in our tertiary care hospital are eligible for the study purpose.
Key inclusion criteria (1 listed)
- all adult patients candidate to planned heart surgery
Key exclusion criteria (4 listed)
- Pregnancy
- Know allergy to iron, or B vitamin, or folic acid
- Hyperferritinemia (ferritin blood value > 300 ng/ml).
- patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseAlso: ferinjectadministration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria | Drug | cases |
| B vitaminadministration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria | Drug | cases |
| Folic acidadministration of a single dose of folic acid in those patietns who fulfill the inclusion criteria | Drug | cases |
Primary outcome
Percentage of patients receiving RBC transfusion within post-operative day 7
Time frame: within post operative day 7
Percentage of patients receiving RBC transfusion within post-operative day 7
10 secondary outcomes
Hb values at last postoperative control within 7 days from surgery
Time frame: within post operative day 7
length of stay in ICU
Time frame: through study completion, an average of 1 year
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
acute kidney injury
Time frame: within the first 7 days post operative
serious adverse events
Time frame: within the first 12 hours after administration
infections requiring antibiotic treatment
Time frame: within the first 7 days post operative
mortality
Time frame: within the first 7 days after surgery
major adverse cardiac and cerebrovascular events
Time frame: within the first 7 days after surgery
cost for the IDA/IDE treatment and blood product costs
Time frame: within the first 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Results publication: PubMed 31036337Spahn 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.
- Derived from this study: PubMed 36401886Corsi 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.
- Haemoglobin concentration for the diagnosis of anaemia and assesment of severityLink provided by the sponsor.
- Perioperative Anemia Management as Part of PBM in Cardiac Surgery - A Narrative Updated ReviewLink provided by the sponsor.
- The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgeryLink provided by the sponsor.
- Does the severity of preoperative anemia or blood transfusion have a stronger impact on long-term survival after cardiac surgery?Link provided by the sponsor.
- Impact of Preoperative Iron Deficiency on Blood Transfusion in Elective Cardiac SurgeryLink provided by the sponsor.
- Iron deficiency impairs contractility of human cardiomyocytes through decreased mitochondrial functionLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be shared upon reasonable request to the PI and after approval by ethic committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
filippo corsi, Dr principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Blood Loss Anemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving RBC transfusion within post-operative day 7 (time frame: within post operative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.