AnemiaICARUS-2NCT06637137
Patient Blood Management in Patients Scheduled for Cardiac Surgery
An observational study of Anemia and Anemia, Iron-Deficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Anemia, Iron-Deficiency, Iron Deficiency Anemia Treatment
- What is being tested?
- Iron
- Type of treatment
- Injection or infusion
- How many people
- 464 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2025to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.
Who may be able to join
- all adult patients scheduled for elective cardiac surgery
Who cannot join
- pregnancy
- dyalisis
- patient's refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luciana Teofili, PhD, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, 00100
filippo Corsi, PI, 0630151
luciana Teofili, PHD, 0630151
About this study
Official title: Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study
The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation.
In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.
Read the detailed description
A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention.
The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).
- Conditions
- Anemia, Anemia, Iron-Deficiency, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia (IDA), Cardiac Surgical Patients, Blood Loss, Surgical
- Being tested
- Iron
- Keywords
- iron, anemia, cardiac surgery, patient blood management
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDrug
Also called folic acid, b vitamin
Patients who present a state of hypoferritinemia or a state of reduced transferrin saturation will undergo administration of i.v iron at least 2 weeks before scheduled cardiac surgery, plus acid folic and B vitamin co-administration.
| Study group | Role | What they receive |
|---|---|---|
| Prospectic cohort | patients scheduled for cardiac surgery who fulfil the inclusion criteria Receives: Drug: Iron | |
| retrospective cohort ICARUS 1 | patients scheduled for cardiac surgery (2021) with a known iron status, treated if indicated 1 or 2 days before surgery with iron supplementation. | |
| retrospective cohort | patients scheduled for cardiac surgery (2019-2020)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
number of RBC units transfused from the operating room till post operative day 7
Measured: within post operative day 7
Secondary outcomes (6)
cost measured in euros for the IDA treatment and blood product consumption
We will assess if ID screening and iron replacement is cost-effective, considering the costs, expressed in euros, of the treatment with ferric carboxymaltose, folic acid and B12 vitamin, the pRBC consumption and hospitalization (either in ICU or in the regular ward).
Measured: from enrollment to 1 week after surgery
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
ICU lenght of stay
lenght of stay in ICU
Measured: through study completion, an average of 2 year
Number of allogenic blood products administered
Number of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
Measured: within the first 7 days post operative
mortality
patients died within the first 7 days after surgery
Measured: from surgery within post operative day 7
Hospital Lenght of Stay
The number of days spent in the hospital
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start24 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 464 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORSI FILIPPO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- luciana Teofili, Phd, Study director, Fondazione Policlinico Gemelli, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637137
- Sponsor's protocol ID
- 6727/2024
- Other IDs
- FPG gemelli IRCCS
- Acronym
- ICARUS-2
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPPD will be shared upon reasonable request to the PPI and after approval of ethic commitee.
Publications
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.
PubMed 36401886
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study
- ClinicalTrials.gov ID
- NCT06637137
- Acronym / sponsor ID
- ICARUS-2 / 6727/2024
- Conditions
- Anemia, Anemia, Iron-Deficiency, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia (IDA), Cardiac Surgical Patients, Blood Loss, Surgical
- Keywords
- iron, anemia, cardiac surgery, patient blood management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation.
In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.
Detailed description
A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention.
The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospectic cohort | – | Drug: Ironpatients scheduled for cardiac surgery who fulfil the inclusion criteria |
| retrospective cohort ICARUS 1 | – | –patients scheduled for cardiac surgery (2021) with a known iron status, treated if indicated 1 or 2 days before surgery with iron supplementation. |
| retrospective cohort | – | –patients scheduled for cardiac surgery (2019-2020)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 patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.
Key inclusion criteria (1 listed)
- all adult patients scheduled for elective cardiac surgery
Key exclusion criteria (3 listed)
- pregnancy
- dyalisis
- 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 |
|---|---|---|
| IronAlso: folic acid, b vitaminPatients who present a state of hypoferritinemia or a state of reduced transferrin saturation will undergo administration of i.v iron at least 2 weeks before scheduled cardiac surgery, plus acid folic and B vitamin co-administration. | Drug | Prospectic cohort |
Primary outcome
Percentage of patients receiving RBC transfusion within post-operative day 7
Time frame: within post operative day 7
number of RBC units transfused from the operating room till post operative day 7
6 secondary outcomes
cost measured in euros for the IDA treatment and blood product consumption
Time frame: from enrollment to 1 week after surgery
Hb values at last postoperative control within 7 days from surgery
Time frame: within post operative day 7
ICU lenght of stay
Time frame: through study completion, an average of 2 year
Number of allogenic blood products administered
Time frame: within the first 7 days post operative
mortality
Time frame: from surgery within post operative day 7
Hospital Lenght of Stay
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: 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.
- Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia.Link provided by the sponsor.
- Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial.Link provided by the sponsor.
- Iron supplementation for patients undergoing cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPPD will be shared upon reasonable request to the PPI and after approval of ethic commitee.
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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.
Luciana Teofili, PhD, MD contact
luciana Teofili, Phd study director
Fondazione Policlinico 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 Anemia, Iron-Deficiency, 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 3 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact filippo Corsi, MD (+390630151, filippo.corsi@policlinicogemelli.it), or a site near the patient. 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 NCT06637137, which also lists 1 linked publication.
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 10 Sep 2026.