NCT06970925EARLY_PHASE1Recruiting

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

Englewood Hospital and Medical Center

Start Date

6/30/2025

Completion Date

6/30/2026

Summary

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

Age Range: 18 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Sucrosomial Iron (SI)

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Conditions

Cardiac Surgery

Locations

Englewood Hospital

Englewood, New Jersey 07631

United States