Patient Blood Management In CARdiac sUrgical patientS

NCT04744181 | Completed

• 1 other identifier: 0047459/20
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Blood Loss Anemia; Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment; Erythropoiesis Abnormal

Outcome Measures

Primary Outcomes (1)

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

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

  within post operative day 7

Secondary Outcomes (10)

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

  within post operative day 7

• length of stay in ICU

  through study completion, an average of 1 year

• number of allogeneic blood products administered

  within the first 7 days post operative

• duration of mechanical ventilation

  within the first 7 days post operative

• acute kidney injury

  within the first 7 days post operative

Study Arms (2)

cases

patients who fulfill the inclusion criteria

Drug: Ferric carboxymaltose; Drug: B vitamin; Drug: Folic acid

controls

Patients who underwent cardiac surgery in 2019 and 2018, with an unknown iron status and never treated with iron supplementation.

Interventions

Ferric carboxymaltose DRUG

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

Also known as: ferinject

cases

B vitamin DRUG

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

cases

Folic acid DRUG

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

cases

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 adult patients candidate to planned heart surgery in our tertiary care hospital are eligible for the study purpose.

You may qualify if:

• \- all adult patients candidate to planned heart surgery

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

FPG Fondazione Policlinico Gemelli IRCCS

Roma, roma, 00100, Italy

Location

Related Publications (2)

• Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.

  PMID: 31036337 BACKGROUND

• 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 DERIVED

Related Links

• Haemoglobin concentration for the diagnosis of anaemia and assesment of severity
• Perioperative Anemia Management as Part of PBM in Cardiac Surgery - A Narrative Updated Review
• The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery
• Does the severity of preoperative anemia or blood transfusion have a stronger impact on long-term survival after cardiac surgery?
• Impact of Preoperative Iron Deficiency on Blood Transfusion in Elective Cardiac Surgery
• Iron deficiency impairs contractility of human cardiomyocytes through decreased mitochondrial function
• Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Vitamin B Complex; Folic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• filippo corsi, Dr

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 8, 2021
• Study Start: January 18, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 31, 2022
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)