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NCT Number: NCT06970925

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

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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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Englewood Hospital

Englewood, New Jersey, 07631, United States

Location status: Recruiting

Location contact

Dara Herman

CONTACT

[email protected]

201-894-3944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in hemoglobin levels

    Time frame: 30 days

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

  2. Financial Cost

    Time frame: 30 Days

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

Secondary outcomes

  1. Transfusion requirements

    Time frame: 30 Days

    Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.

  2. Length of Stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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