Patient Blood Management in Patients Scheduled for Cardiac Surgery (ICARUS-2)

February 24, 2025 updated by: CORSI FILIPPO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Luciana Teofili, PhD, MD
  • Phone Number: +390630151

Study Locations

  • Italy
      • Roma, Italy, 00100
        • Recruiting
        • Fondazione Policlinico Gemelli IRCCS
        • Contact:
          • filippo Corsi, PI
          • Phone Number: 0630151
        • Contact:
          • luciana Teofili, PHD
          • Phone Number: 0630151
        • Contact:
          • filippo corsi, PI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.

Description

Inclusion Criteria:

- all adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

  • pregnancy
  • dyalisis
  • patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospectic cohort
patients scheduled for cardiac surgery who fulfil the inclusion criteria
Drug: Iron
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.
Other Names:
  • folic acid
  • b vitamin
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: within post operative day 7
Hb values at last postoperative control within 7 days from surgery
within post operative day 7
cost measured in euros for the IDA treatment and blood product consumption
Time Frame: from enrollment to 1 week after surgery
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).
from enrollment to 1 week after surgery
ICU lenght of stay
Time Frame: through study completion, an average of 2 year
lenght of stay in ICU
through study completion, an average of 2 year
Number of allogenic blood products administered
Time Frame: within the first 7 days post operative
Number of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
within the first 7 days post operative
mortality
Time Frame: from surgery within post operative day 7
patients died within the first 7 days after surgery
from surgery within post operative day 7
Hospital Lenght of Stay
Time Frame: through study completion, an average of 2 year
The number of days spent in the hospital
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Director: luciana Teofili, Phd, Fondazione Policlinico Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6727/2024
  • FPG gemelli IRCCS (Other Identifier: FPG gemelli IRCCS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPPD will be shared upon reasonable request to the PPI and after approval of ethic commitee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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