Patient Blood Management In CARdiac sUrgical patientS

NCT ID: NCT04744181

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 479 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2022-01-31

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.

Detailed Description

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.

Conditions

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

Study Design

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

Study Groups

cases

patients who fulfill the inclusion criteria

Ferric carboxymaltose

Intervention Type: DRUG

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

B vitamin

Intervention Type: DRUG

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

Folic acid

Intervention Type: DRUG

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

controls

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

No interventions assigned to this group

Interventions

Ferric carboxymaltose

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

Intervention Type: DRUG

B vitamin

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

Intervention Type: DRUG

Folic acid

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

Intervention Type: DRUG

Other Intervention Names

ferinject

Eligibility Criteria

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

• 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

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

filippo corsi, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

FPG Fondazione Policlinico Gemelli IRCCS

Roma, roma, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 31036337 (View on PubMed)

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: DERIVED

PMID: 36401886 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Related Links

https://apps.who.int/iris/bitstream/handle/10665/85839/WHO_NMH_NHD_MNM_11.1_eng.pdf?ua=1

Haemoglobin concentration for the diagnosis of anaemia and assesment of severity

https://linkinghub.elsevier.com/retrieve/pii/S1053-0770(19)30639-1

Perioperative Anemia Management as Part of PBM in Cardiac Surgery - A Narrative Updated Review

https://research-repository.uwa.edu.au/en/publications/the-impact-of-anaemia-and-intravenous-iron-replacement-therapy-on

The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery

https://linkinghub.elsevier.com/retrieve/pii/S0022-5223(16)30564-5

Does the severity of preoperative anemia or blood transfusion have a stronger impact on long-term survival after cardiac surgery?

https://linkinghub.elsevier.com/retrieve/pii/S1053-0770(19)30108-9

Impact of Preoperative Iron Deficiency on Blood Transfusion in Elective Cardiac Surgery

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5993224/

Iron deficiency impairs contractility of human cardiomyocytes through decreased mitochondrial function

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3200-3

Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial

Other Identifiers

0047459/20

Identifier Type: -

Identifier Source: org_study_id