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NCT Number: NCT06637137

Patient Blood Management in Patients Scheduled for Cardiac Surgery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, 00100, Italy

Location status: Recruiting

Location contact

filippo Corsi, PI

CONTACT

0630151

filippo corsi, PI

PRINCIPAL_INVESTIGATOR

luciana Teofili, PHD

CONTACT

0630151

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all adult patients scheduled for elective cardiac surgery

Exclusion criteria

  • pregnancy
  • dyalisis
  • patient's refusal

Treatment and study plan

Iron

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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

  3. ICU lenght of stay

    Time frame: through study completion, an average of 2 year

    lenght of stay in ICU

  4. 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).

  5. mortality

    Time frame: from surgery within post operative day 7

    patients died within the first 7 days after surgery

  6. Hospital Lenght of Stay

    Time frame: through study completion, an average of 2 year

    The number of days spent in the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Luciana Teofili, PhD, MD

CONTACT

+390630151

filippo Corsi, MD

CONTACT

[email protected]

+390630151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ICARUS-2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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