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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Cardiac Surgery

NCT06970925

Englewood Hospital and Medical Center

15 October 2025

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