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

RecruitingEarly phase 1

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

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Englewood Hospital and Medical Center · Participants: 40 · Started: Jun 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06970925

Locations in the U.S.

New JerseyEnglewood Hospital, Englewood

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.