Patient Blood Management In CARdiac sUrgical patientS

Anemia Clinical Trial

— ICARUS  

Official title:

Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744181
• Other study ID #: 0047459/20
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: January 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Blood Loss Anemia
• Deficiency Diseases
• Erythropoiesis Abnormal
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment
• Iron-deficiency

Intervention

Drug:
• Ferric carboxymaltose
administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria
• B vitamin
administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria
• Folic acid
administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria

Locations

Country	Name	City	State
Italy	FPG Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hb values at last postoperative control within 7 days from surgery	Hb values at last postoperative control within 7 days from surgery	within post operative day 7
Secondary	length of stay in ICU	length of stay in ICU	through study completion, an average of 1 year
Secondary	number of allogeneic blood products administered	number of allogeneic blood products administered	within the first 7 days post operative
Secondary	duration of mechanical ventilation	duration of mechanical ventilation	within the first 7 days post operative
Secondary	acute kidney injury	worsening of renal function	within the first 7 days post operative
Secondary	serious adverse events	including hypersensitivity reactions	within the first 12 hours after administration
Secondary	infections requiring antibiotic treatment	infections requiring antibiotic treatment	within the first 7 days post operative
Secondary	mortality	patients died within the first 7 days after surgery	within the first 7 days after surgery
Secondary	major adverse cardiac and cerebrovascular events	cardiogenic shock, neurological events	within the first 7 days after surgery
Secondary	cost for the IDA/IDE treatment and blood product costs	cost for the IDA/IDE treatment and blood product costs	within the first 7 days after surgery

External Links

•   A systematic analysis of global anemia burden from 1990 to 2010
•   Anemia and Iron Deficiency in Heart Failure
•   Does the severity of preoperative anemia or blood transfusion have a stronger impact on long-term survival after cardiac surgery?
•   Haemoglobin concentration for the diagnosis of anaemia and assesment of severity
•   Impact of Preoperative Iron Deficiency on Blood Transfusion in Elective Cardiac Surgery
•   Iron deficiency impairs contractility of human cardiomyocytes through decreased mitochondrial function
•   Iron-Deficiency Anemia
•   Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial
•   Myocardial and Systemic Iron Depletion in Heart Failure: Implications for Anemia Accompanying Heart Failure
•   Patient blood management in the cardiac surgical setting: An updated overview
•   Patterns and determinants of functional and absolute iron deficiency in patients undergoing cardiac rehabilitation following heart surgery
•   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
•   The impact of minor blood transfusion on the outcome after coronary artery bypass grafting