Clinical Trial

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

Recruiting Early Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated August 7, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-13.
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06970925
Lead Sponsor Englewood Hospital and Medical Center
Conditions Cardiac Surgery
Enrollment 40 participants
Start Date 2025-06-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-07