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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnglewood Hospital and Medical Center

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sucrosomial Iron (SI)

Treatment groups

40 Participants
are divided into 2 treatment groups