NCT06970925 Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
| NCT ID | NCT06970925 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Englewood Hospital and Medical Center |
| Condition | Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-06-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06970925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06970925 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06970925 currently recruiting?
Yes, NCT06970925 is actively recruiting participants. Visit ClinicalTrials.gov or contact Englewood Hospital and Medical Center to inquire about joining.
Where is the NCT06970925 trial being conducted?
This trial is being conducted at Englewood, United States.
Who is sponsoring the NCT06970925 clinical trial?
NCT06970925 is sponsored by Englewood Hospital and Medical Center. The trial plans to enroll 40 participants.