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 pre-operative Hb and decrease transfusion requirements in elective cardiac surgery, especially in those anemic at baseline.
References
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Authors
Luca P. Weltert
Heart Surgery, European Hospital, Rome, Italy
Alessandro De Rosa Transfusion Medicine Department "San Camillo Forlanini" Hospital, Rome, Italy
Maria B. Rondinelli
Transfusion Medicine Department "San Camillo Forlanini" Hospital, Rome, Italy;
Mauro Falco Anesthesiology Department, European Hospital, Rome, Italy
Franco Turani
Anesthesiology Department, "Aurelia" Hospital, Rome, Italy
Luca Pierelli Transfusion Medicine Department "San Camillo Forlanini" Hospital, Rome, Italy
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