Sucrosomial Iron for Recovery After Cardiac Surgery

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Englewood Hospital and Medical Center

Disqualifiers: Cancer, Chronic conditions, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

Trial Summary

What is the purpose of 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

This trial is for individuals who have recently undergone cardiac surgery and are in need of post-operative iron supplementation. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed inclusion and exclusion criteria.

Inclusion Criteria

My hemoglobin is below 12, indicating I am anemic after surgery.

Patients following the same pre-operative protocol

I was in the ICU after having planned heart surgery.

Exclusion Criteria

Post operative day 1 Hg <9

I am over 90 years old.

I have a condition that affects my body's ability to produce red blood cells.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sucrosomial® Iron supplementation or Iron Sucrose injections post-operatively

4 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for changes in hemoglobin levels, transfusion requirements, and length of hospital/ICU stay

4 weeks

Treatment Details

Interventions

• Sucrosomial Iron

Trial Overview The study is testing whether Sucrosomial Iron (SI) taken after heart surgery can improve hemoglobin levels as effectively as the standard treatment with Iron Sucrose (IV). It also compares costs, transfusion needs, and hospital/ICU stay durations between the two treatments.

Participant Groups

Group I: Sucrosomial® Iron Experimental Treatment 1 Intervention

Patients will receive iron supplementation with Sucrosomial® Iron

Group II: Iron Sucrose injections. Active Control 1 Intervention

Patients will receive standard of care Iron Sucrose injections.

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials

21

Recruited

770+