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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Sucrosomial Iron, an iron supplement, is as effective as Iron Sucrose injections in boosting hemoglobin levels after heart surgery. Researchers aim to determine if the new treatment can reduce hospital costs, such as ICU stays, and decrease the need for blood transfusions. The study seeks participants who have undergone heart surgery, are recovering in the ICU, and have low iron levels or anemia. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sucrosomial Iron is usually easy for people to tolerate. In one study, 98.2% of patients who took Sucrosomial Iron before heart surgery reported few or no side effects. Another study found it to be a safe choice for treating low iron and anemia (a low red blood cell count) after heart surgery. This indicates that most people can take Sucrosomial Iron without many problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Sucrosomial® Iron because it offers a novel approach to iron supplementation after cardiac surgery. Unlike traditional iron treatments like Iron Sucrose injections, which are administered intravenously, Sucrosomial® Iron is taken orally and is designed to enhance iron absorption without causing common side effects such as gastrointestinal discomfort. This innovative delivery method could improve patient comfort and adherence while still effectively replenishing iron levels, which is crucial for recovery after surgery.

What evidence suggests that Sucrosomial Iron might be an effective treatment for improving hemoglobin levels after cardiac surgery?

Research has shown that Sucrosomial Iron, which participants in this trial may receive, can improve hemoglobin levels in patients after heart surgery. One study found that short-term use of Sucrosomial Iron led to similar improvements in key blood health measures and physical ability compared to other treatments. Clinical studies support Sucrosomial Iron as an effective option for treating iron deficiency and iron deficiency anemia, especially post-surgery. It is also well-tolerated by patients, suggesting Sucrosomial Iron may be a reliable choice for aiding recovery after heart surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10335347/

Benefits of pre-operative oral Sucrosomial® iron ... Our previously published paper suggested that pre-operative oral Sucrosomial® iron administration in heart surgery was a safe (98.2% demonstrated good tolerance ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07038330

Study Details | NCT07038330 | DOSE FINDING ... Evaluation of the efficacy of short-term sucrosomial iron treatment in patients undergoing cardiac surgery and subsequently transferred to rehabilitation, ...

3. academic.oup.com academic.oup.com/eurjpc/article/31/Supplement_1/zwae175.219/7692505

Added value of therapy with sucrosomial iron (SI) on top on ... Short-term treatment of IDA after CS using FMC or SI showed a significant similar improvement of key hematological parameters (HP) and in functional capacity.

4. mdpi.com mdpi.com/1424-8247/16/6/847

Sucrosomial® Iron: An Updated Review of Its Clinical ... The evidence derived from clinical studies supports the use of Sucrosomial iron as a valid first option for the treatment of ID and IDA.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352906722000872

Short-term treatment of iron deficiency anemia after cardiac ... The study shows that SI can be a viable alternative to FCM after cardiac surgery in terms of effectiveness and tolerability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10305423/

Sucrosomial® Iron: An Updated Review of Its Clinical Efficacy ... The evidence derived from clinical studies supports the use of Sucrosomial iron as a valid first option for the treatment of ID and IDA.

7. ahajournals.org ahajournals.org/doi/10.1161/circ.142.suppl_3.13109

Abstract 13109: Oral and Intravenous Iron Therapy for ... Cardiac surgery is associated with a high risk to develop iron deficiency anemia (IDA) with impact on the Cardiac Rehabilitation (CR) program.