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

RecruitingEARLY Phase 1Ages 18 Years - anyAllEnglewood Hospital and Medical Center
NCT06970925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Sucrosomial Iron (SI)
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Where

1 site
Englewood Hospital
Englewood, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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