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Completed

NCT Number: NCT04744181

Patient Blood Management In CARdiac sUrgical patientS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all adult patients candidate to planned heart surgery

Exclusion criteria

  • Pregnancy
  • Know allergy to iron, or B vitamin, or folic acid
  • Hyperferritinemia (ferritin blood value > 300 ng/ml).
  • patient's refusal

Treatment and study plan

ferric carboxymaltose

Drug

administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria

Other names: ferinject

B vitamin

Drug

administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria

Folic Acid

Drug

administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. length of stay in ICU

    Time frame: through study completion, an average of 1 year

    length of stay in ICU

  3. number of allogeneic blood products administered

    Time frame: within the first 7 days post operative

    number of allogeneic blood products administered

  4. duration of mechanical ventilation

    Time frame: within the first 7 days post operative

    duration of mechanical ventilation

  5. acute kidney injury

    Time frame: within the first 7 days post operative

    worsening of renal function

  6. serious adverse events

    Time frame: within the first 12 hours after administration

    including hypersensitivity reactions

  7. infections requiring antibiotic treatment

    Time frame: within the first 7 days post operative

    infections requiring antibiotic treatment

  8. mortality

    Time frame: within the first 7 days after surgery

    patients died within the first 7 days after surgery

  9. major adverse cardiac and cerebrovascular events

    Time frame: within the first 7 days after surgery

    cardiogenic shock, neurological events

  10. cost for the IDA/IDE treatment and blood product costs

    Time frame: within the first 7 days after surgery

    cost for the IDA/IDE treatment and blood product costs

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 Study

Acronym: ICARUS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Aug 14, 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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