Benefits of pre-operative oral Sucrosomial(®) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender

Heart Surgery, European Hospital, Rome, Italy. Transfusion Medicine Department "San Camillo Forlanini" Hospital, Rome, Italy. Anesthesiology Department, European Hospital, Rome, Italy. Anesthesiology Department, "Aurelia" Hospital, Rome, Italy.

Blood transfusion = Trasfusione del sangue. 2022
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PICO Summary

Population

Cardiac surgery patients (n= 594).

Intervention

Sucrosomial® iron prior to elective cardiac surgery (Iron group, n= 309).

Comparison

Routine care (Control group, n= 285).

Outcome

This post-hoc analysis of a large, randomized clinical trial (n= 1,000) reanalyzed data according to treatment, baseline anemia (Hb <13 g/dL) or gender. At hospital admission, haemoglobin (Hb) had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively, with no gender-related differences, leading to a decrease in transfusion rate (30 vs. 59%, respectively) and transfusion index (0.5 units/patient vs. 1.2 units/pt, respectively). Sucrosomial® iron administration was well-tolerated, and yielded cost-savings of €92/pt, particularly in those presenting with baseline Hb <13 g/dL.
Abstract
BACKGROUND The prevalence of low pre-operative hemoglobin (Hb) among cardiac surgery patients is high. As iron homeostasis is often impaired in these patients, restoration of iron availability might over-ride iron-restricted erythropoiesis. This post-hoc analysis of a previously published, large, randomized clinical trial (ClincalTrials.gov NCT03560687; n=1,000) assesses which sub-cohort of patients benefits the most from pre-operative Hb optimization with oral Sucrosomial(®) iron. MATERIALS AND METHODS Patients without baseline Hb (n=349) or receiving >5 red blood cell units (n=57) were excluded from the study. Data from the remaining 594 were reanalyzed according to treatment, baseline anemia (Hb <13 g/dL) or gender. Patients (pt) received a one-month course of 60 mg/day Sucrosomial(®) iron (Iron group, n=309) or routine care (Control group, n=285) prior to elective cardiac surgery. Main end-point variables were increase in Hb from randomization to hospital admission, transfusion requirements, and cost-effectiveness of Sucrosomial(®) iron administration. RESULTS At hospital admission, Hb had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively (p<0.001), with no gender-related differences, leading to a decrease in transfusion rate (30 vs 59%, respectively; p<0.001) and transfusion index (0.5 units/patient vs 1.2 units/pt, respectively; p<0.001). Sucrosomial(®) iron administration was well-tolerated, and yielded cost-savings of €92/pt (p<0.001), particularly in those presenting with baseline Hb <13 g/dL. CONCLUSIONS This post-hoc analysis confirms pre-operative Sucrosomial(®) iron administration is a safe and cost-effective strategy to increase preoperative Hb and decrease transfusion requirements in elective cardiac surgery, especially in those anemic at baseline.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine