Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments.
Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length
ICU hospitalized patients who underwent non-emergent cardiac surgery
Post operative iron deficient or anemic patients (Hb< 12 for both men and women).
Patients following the same pre-operative protocol
Age >18 years
Post operative day 1 Hg <9
Age >90 years
Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
Stage 3, 4 renal disease
Parallel
Sucrosomial Iron (SI)
Dietary supplementThe Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food \& Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra.
Change in hemoglobin levels
Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.
Financial Cost
Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)
Transfusion requirements
Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.
Length of Stay
Length of hospital stay measured from the date of surgery to discharge. Length of ICU stay measured from date of surgery to date of ICU discharge.
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