Recruiting
Early Phase 1

Sucrosomial® Iron & Iron Sucrose

Sponsor:

Englewood Hospital and Medical Center

Code:

NCT06970925

Conditions

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sucrosomial Iron (SI)

Study Details

Brief 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

Conditions

Cardiac Surgery

Study ID

NCT06970925

Start date

Jun 30, 2025

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Sucrosomial Iron (SI)

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.

Primary outcome measure

  • Change in hemoglobin levels [ Time Frame: 30 days ]
  • Financial Cost [ Time Frame: 30 Days ]

Central Contacts and Locations

Locations

Englewood Hospital

Recruiting

Englewood, New Jersey, United States, 07631

Contacts

Dara Herman

201-894-3944dara.herman@ehmchealth.org

More Information

Sponsor

Englewood Hospital and Medical Center

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Englewood Hospital and Medical Center on 2025-08-07.