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

Recruiting now · Early Phase 1

Conditions studied: Cardiac Surgery

In brief

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

Key facts

Study ID

NCT06970925

Run by

Englewood Hospital and Medical Center

People needed

40

Starts

2025-06-30

Expected to finish

2026-06-30

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Englewood Hospital — Englewood, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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