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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Anemia; Iron Deficiency Anemia Treatment; Blood Loss, Surgical; Iron Deficiency Anemia (IDA); Anemia, Iron-Deficiency; Cardiac Surgical Patients

Treatments: Drug: Iron

Study type: Observational

Funder types: Other

Identifiers

NCT06637137

6727/2024

FPG gemelli IRCCS (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 464 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all adult patients scheduled for elective cardiac surgery

Exclusion criteria

• pregnancy
• dyalisis
• patient's refusal

Trial design

464 participants in 3 patient groups

Prospectic cohort

Description:

patients scheduled for cardiac surgery who fulfil the inclusion criteria

Treatment:

Drug: Iron

retrospective cohort ICARUS 1

Description:

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

Description:

patients scheduled for cardiac surgery (2019-2020)with an unknown iron status and never treated with iron supplementation