Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sucrosomial Iron (SI).
- Who it may be relevant to
- Registry conditions: Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
Overview
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 supplement 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 measures
- Change in hemoglobin levels [Time frame: 30 days]
- Financial Cost [Time frame: 30 Days]
Secondary outcome measures (2)
- Transfusion requirements [Time frame: 30 Days]
- Length of Stay [Time frame: 30 Days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Englewood Hospital — Englewood
Identifiers
NCT: NCT06970925 · E-25-119