Patient Blood Management in Patients Scheduled for Cardiac Surgery

NCT06637137 | Recruiting

• 2 other identifiers: 6727/2024FPG gemelli IRCCS
• Study Type: observational
• Target: 464
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

iron; anemia; cardiac surgery; patient blood management

Outcome Measures

Primary Outcomes (1)

• Percentage of patients receiving RBC transfusion within post-operative day 7

  number of RBC units transfused from the operating room till post operative day 7

  within post operative day 7

Secondary Outcomes (6)

• cost measured in euros for the IDA treatment and blood product consumption

  from enrollment to 1 week after surgery

• Hb values at last postoperative control within 7 days from surgery

  within post operative day 7

• ICU lenght of stay

  through study completion, an average of 2 year

• Number of allogenic blood products administered

  within the first 7 days post operative

• mortality

  from surgery within post operative day 7

Study Arms (3)

Prospectic cohort

patients scheduled for cardiac surgery who fulfil the inclusion criteria

Drug: Iron

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.

retrospective cohort

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

Interventions

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.

Also known as: folic acid, b vitamin

Prospectic cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients candidate for elective cardiac surgery at our tertiary care hospital are eligible for the study purpose.

You may qualify if:

• \- all adult patients scheduled for elective cardiac surgery

You may not qualify if:

• pregnancy
• dyalisis
• patient's refusal

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36401886 BACKGROUND

Related Links

• Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia.
• Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial.
• Iron supplementation for patients undergoing cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Blood Loss, Surgical

Interventions

Iron; Folic Acid; Vitamin B Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• luciana Teofili, Phd

  Fondazione Policlinico Gemelli, IRCCS

  STUDY DIRECTOR

Central Study Contacts

filippo Corsi, MD

CONTACT

+390630151; filippo.corsi@policlinicogemelli.it

Luciana Teofili, PhD, MD

CONTACT

+390630151

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Meidcal doctor, principal investigator

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)