Sucrosomial oral iron versus standard iron care after heart surgery
Official title: Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
Run by Englewood Hospital and Medical Center · NCT06970925 · Data updated 2026-11-12
This trial will try sucrosomial oral iron to see if it raises hemoglobin as well as standard care in adults with iron deficiency or anemia after non-emergency heart surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Englewood Hospital and Medical Center Academic / other |
| Locations | 1 site (Englewood, New Jersey) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06970925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 who undergo non-emergent cardiac surgery and have postoperative iron deficiency or anemia (hemoglobin <12 g/dL) without excluded comorbidities are the intended participants.
✕Probably not a fit
Patients with very low hemoglobin on postoperative day 1 (<9 g/dL), age over 90, advanced renal disease (stage 3–4), active cancer or marrow disorders, or who received intraoperative transfusions are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot interventional study compares post-operative sucrosomial oral iron with standard care (iron sucrose) in adults following non-emergent cardiac surgery. The primary aim is to show non-inferiority in hemoglobin improvement within 30 days after surgery. Secondary outcomes include treatment costs, transfusion requirements, and lengths of hospital and ICU stay. Eligible participants are adults with postoperative iron deficiency or anemia treated at Englewood Hospital in Englewood, New Jersey.
Why it matters
Potential benefit: If sucrosomial oral iron is non-inferior, patients could receive effective oral treatment that avoids IV iron, reduces costs, and may lower transfusion needs and hospital resource use.
How similar studies have gone: Oral sucrosomial iron has shown effectiveness for correcting iron deficiency in other settings, but direct evidence replacing IV iron after cardiac surgery is limited.
Who can join: the full rules
Show full inclusion / exclusion 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 and 2 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
Where it's running
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Englewood Hospital
Englewood, New Jersey, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.