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

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06970925

Enrollment

Registered

2025-05-14

Start date

2025-06-30

Completion date

2026-06-30

Last updated

2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

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

Interventions

DIETARY_SUPPLEMENTSucrosomial 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026