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

NCT06970925 — Early Phase 1, Recruiting, 40 participants, Englewood Hospital and Medical Center

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Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery

Registry	NCT06970925
Status	Recruiting
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	40 (Estimated)
Sponsor	Englewood Hospital and Medical Center (Other)
Conditions	Cardiac Surgery
Interventions	Sucrosomial Iron (SI) (Dietary supplement)
Dates	start 2025-06-30, primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2025-05-14, last updated 2025-08-07
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Sucrosomial® Iron	Experimental	Dietary Supplement: Sucrosomial Iron (SI)	Patients will receive iron supplementation with Sucrosomial® Iron
Iron Sucrose injections.	Active comparator	Dietary Supplement: Sucrosomial Iron (SI)	Patients will receive standard of care Iron Sucrose injections.

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.

+Outcome measures

Primary outcomes

Change in hemoglobin levels [30 days]: Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.
Financial Cost [30 Days]: Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)

Secondary outcomes

Transfusion requirements [30 Days]: Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.
Length of Stay [30 Days]: Length of hospital stay measured from the date of surgery to discharge. Length of ICU stay measured from date of surgery to date of ICU discharge.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Englewood Hospital	Englewood, New Jersey	United States	Recruiting