Actively Recruiting

Age: 18Years +
All Genders
ID06637137

Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-02-26

464

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying patients scheduled for elective cardiac surgery to improve management of iron deficiency and reduce the need for blood transfusions during and after surgery. This observational study focuses on optimizing hemoglobin levels by correcting low iron levels prior to surgery. The goal is to enhance recovery from blood loss related to cardiac surgery, supported by current patient blood management programs. Participants with low iron or iron deficiency will receive intravenous iron treatment at least two weeks before their scheduled surgery, along with vitamin B12 injections and oral folic acid. The study compares groups of patients treated early with iron supplementation, those treated shortly before surgery, and those with unknown iron status who did not receive treatment. This approach aims to assess how earlier correction of iron deficiency affects outcomes. During the study, researchers will monitor the number of blood transfusions given within seven days after surgery, hemoglobin values, length of stay in intensive care and hospital, mortality rates, and costs related to iron deficiency treatment and blood product use. Data collection will continue for about two years. Participants will have blood tests and receive treatments as part of standard clinical care while researchers observe and record relevant health outcomes.

CONDITIONS

Brief Title

Patient Blood Management in Patients Scheduled for Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All adult patients scheduled for elective cardiac surgery
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Dialysis
  • Patient's refusal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - At least 2 weeks before surgery plus 7 days post-operative

Participants who present iron deficiency receive intravenous iron treatment, vitamin B12, and oral folic acid at least 2 weeks before their scheduled cardiac surgery and are observed through surgery and the following week.

1 visit for iron administration and daily oral supplementation; follow-up visits during 7 days after surgery

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Gemelli IRCCS

Roma, Italy, 00100

Actively Recruiting

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Research Team

F

filippo Corsi, MD

L

Luciana Teofili, PhD, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial