Patient Blood Management In CARdiac sUrgical patientS

Completed

• Conditions: Anemia; Blood Loss Anemia; Iron Deficiency Anemia Treatment; Iron-deficiency; Erythropoiesis Abnormal; Iron Deficiency Anemia
• Interventions: Drug: Ferric carboxymaltose; Drug: B vitamin; Drug: Folic acid

• Registration Number: NCT04744181
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-02
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cases	Ferric carboxymaltose	patients who fulfill the inclusion criteria
cases	B vitamin	patients who fulfill the inclusion criteria
cases	Folic acid	patients who fulfill the inclusion criteria

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FPG Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy