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

NCT06970925 | Recruiting Early Phase 1

• 1 other identifier: E-25-119
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in hemoglobin levels

  Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.

  30 days

• Financial Cost

  Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)

  30 Days

Secondary Outcomes (2)

• Transfusion requirements

  30 Days

• Length of Stay

  30 Days

Study Arms (2)

Sucrosomial® Iron

EXPERIMENTAL

Patients will receive iron supplementation with Sucrosomial® Iron

Dietary Supplement: Sucrosomial Iron (SI)

Iron Sucrose injections.

ACTIVE COMPARATOR

Patients will receive standard of care Iron Sucrose injections.

Dietary Supplement: Sucrosomial Iron (SI)

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.

Iron Sucrose injections.; Sucrosomial® Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Hospital

Englewood, New Jersey, 07631, United States

RECRUITING

MeSH Terms

Interventions

sucrosomial iron

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)