Cardiac SurgeryEarly Phase 1NCT06970925
Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
A Early Phase 1 study testing Sucrosomial Iron (SI) in people with Cardiac Surgery, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Sucrosomial Iron (SI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Englewood Hospital
Englewood, New Jersey, 07631
Dara Herman, 201-894-3944, dara.herman@ehmchealth.org
About this study
Official title: Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
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
- Conditions
- Cardiac Surgery
- Being tested
- Sucrosomial Iron (SI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial Iron (SI)Dietary supplement
The Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food \& Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra.
| Study group | Role | What they receive |
|---|---|---|
| Sucrosomial® Iron | Experimental | Patients will receive iron supplementation with Sucrosomial® Iron Receives: Dietary Supplement: Sucrosomial Iron (SI) |
| Iron Sucrose injections. | Active comparator | Patients will receive standard of care Iron Sucrose injections. Receives: Dietary Supplement: Sucrosomial Iron (SI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin levels
Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.
Measured: 30 days
Financial Cost
Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)
Measured: 30 Days
Secondary outcomes (2)
Transfusion requirements
Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.
Measured: 30 Days
Length of Stay
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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970925
- Sponsor's protocol ID
- E-25-119
- Status last verified
- Aug 2025
- First submitted
- 6 May 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06970925
- Acronym / sponsor ID
- E-25-119
- Conditions
- Cardiac Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrosomial® Iron | Experimental | Dietary Supplement: Sucrosomial Iron (SI)Patients will receive iron supplementation with Sucrosomial® Iron |
| Iron Sucrose injections. | Active comparator | Dietary Supplement: Sucrosomial Iron (SI)Patients will receive standard of care Iron Sucrose injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrosomial Iron (SI)The Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food \& Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra. | Dietary supplement | Iron Sucrose injections., Sucrosomial® Iron |
Primary outcome
Change in hemoglobin levels
Time frame: 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
Time frame: 30 Days
Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)
2 secondary outcomes
Transfusion requirements
Time frame: 30 Days
Length of Stay
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sucrosomial Iron (SI) in people with Cardiac Surgery, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin levels (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.