RecruitingEarly Phase 1NCT06970925

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

Sponsor

Englewood Hospital and Medical Center

Enrollment

40 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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

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Interventions

DIETARY_SUPPLEMENTSucrosomial Iron (SI)

The 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.