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

Early Phase 1

Not yet recruiting

• Conditions: Cardiac Surgery

• Registration Number: NCT06970925
• Lead Sponsor: Englewood Hospital and Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Start: 2025-06-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin levels	30 days	Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.
Financial Cost	30 Days	Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)

Secondary Outcome Measures

Name	Time	Method
Transfusion requirements	30 Days	Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.
Length of Stay	30 Days	Length of hospital stay measured from the date of surgery to discharge. Length of ICU stay measured from date of surgery to date of ICU discharge.

Trial Locations

Locations (1)

Englewood Hospital; 🇺🇸 Englewood, New Jersey, United States