Patient Blood Management in Patients Scheduled for Cardiac Surgery

NCT ID: NCT06637137

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 464 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2027-02-28

Brief Summary

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.

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).

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospectic cohort

patients scheduled for cardiac surgery who fulfil the inclusion criteria

Iron

Intervention Type: 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.

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.

No interventions assigned to this group

retrospective cohort

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

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

folic acid; b vitamin

Eligibility Criteria

Inclusion Criteria

• all adult patients scheduled for elective cardiac surgery

Exclusion Criteria

• pregnancy
• dyalisis
• patient's refusal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

CORSI FILIPPO

Meidcal doctor, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

luciana Teofili, Phd

Role: STUDY_DIRECTOR

Fondazione Policlinico Gemelli, IRCCS

Locations

Fondazione Policlinico Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

filippo Corsi, MD

Role: CONTACT

filippo.corsi@policlinicogemelli.it

+390630151

Luciana Teofili, PhD, MD

Role: CONTACT

+390630151

Facility Contacts

filippo Corsi, PI

Role: primary

0630151

luciana Teofili, PHD

Role: backup

0630151

References

Corsi F, Pasquini A, Guerrera M, Bevilacqua F, Taccheri T, Antoniucci ME, Calabrese M, Valentini CG, Orlando N, Bartolo M, Cannetti G, Pellegrino C, Cavaliere F, Teofili L. Single shot of intravenous iron in cardiac surgery: The ICARUS study. J Clin Anesth. 2023 Feb;84:111009. doi: 10.1016/j.jclinane.2022.111009. Epub 2022 Nov 16.

Reference Type: BACKGROUND

PMID: 36401886 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37838604/

Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia.

https://pubmed.ncbi.nlm.nih.gov/31036337/

Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial.

https://pubmed.ncbi.nlm.nih.gov/34559371/

Iron supplementation for patients undergoing cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

Other Identifiers

FPG gemelli IRCCS

Identifier Type: OTHER

Identifier Source: secondary_id

6727/2024

Identifier Type: -

Identifier Source: org_study_id