Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery

Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Intraoperative transfusion of PRBC