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

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Englewood Hospital and Medical Center
Study ID
NCT06970925
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Cardiac Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sucrosomial Iron (SI) — DIETARY_SUPPLEMENT
    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.

Study Details

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 Dates

Start date
Jun 30, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Sucrosomial® Iron
    Patients will receive iron supplementation with Sucrosomial® Iron
  • Active Comparator: Iron Sucrose injections.
    Patients will receive standard of care Iron Sucrose injections.

Primary Outcome Measure

Change in hemoglobin levels [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Englewood HospitalEnglewoodNew Jersey07631
Dara Herman
[email protected]
201-894-3944

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By research site
Englewood Hospital· Englewood, NJ

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