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

Englewood Hospital and Medical Center

Status and phase: Enrolling; Early Phase 1

Conditions: Cardiac Surgery

Treatments: Dietary Supplement: Sucrosomial Iron (SI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06970925

E-25-119

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Sucrosomial® Iron

Experimental group

Description:

Patients will receive iron supplementation with Sucrosomial® Iron

Treatment:

Dietary Supplement: Sucrosomial Iron (SI)

Iron Sucrose injections.

Active Comparator group

Description:

Patients will receive standard of care Iron Sucrose injections.

Treatment:

Dietary Supplement: Sucrosomial Iron (SI)