About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sucrosomial Iron (SI)