Actively Recruiting
Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Led by Englewood Hospital and Medical Center · Updated on 2025-08-07
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Post operative day 1 hemoglobin less than 9
- Age over 90 years
- Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
- Stage 3 or 4 renal disease
- Intraoperative transfusion of PRBC
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Englewood Hospital
Englewood, New Jersey, United States, 07631
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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