Sucrosomial Vs Intravenous Iron for Preoperative Anemia

This study is for people aged 18 or older who have anemia (low red blood cell count) and are scheduled for certain heart surgeries or procedures. It compares two ways to treat anemia before surgery: oral sucrosomial iron capsules taken at home, or two infusions of intravenous (IV) iron (ferumoxytol) given through a vein at the hospital. The main goal is to see if oral sucrosomial iron is as effective as IV iron in increasing your hemoglobin (a protein in red blood cells that carries oxygen) by the day of your surgery. The study plans to enroll 75 participants, but the current enrollment status is unclear.

Study design: This interventional study will randomly assign participants to one of two treatment groups: oral sucrosomial iron or intravenous iron. It aims to enroll 75 participants.
What's involved: You would either take oral sucrosomial iron capsules daily at home until surgery, or receive two intravenous iron infusions at the hospital. A blood sample will be taken on the day of surgery.
Compensation: Not stated in the trial record.
Follow-up: Your hemoglobin will be measured from your pre-operative visit up to the day of surgery or procedure, which is approximately eight weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Not Yet Recruiting

PHASE4Ages 18+InterventionalTreatment

University of Rochester

~75 participants

Updated 2025-12-17 on ClinicalTrials.gov

What's tested:Treatment with oral sucrosomial ironTreatment with intravenous iron

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in hemoglobin from baseline to day of surgery or procedure

Measured over From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks

Conditions

Anemia

Iron Deficiency Anemia

NCT07287371

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of Rochester
Rochester, New Yorkstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Michael P Eaton, MD · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Michael Eaton, MD

[email protected]

585-275-7056

Email the study team

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Eligibility criteria

Inclusion

Age ≥18 years

Scheduled for elective cardiac surgical procedures, including:

Coronary artery bypass graft surgery (CABG)

Valve procedures

Aortic root procedures

Transcatheter aortic valve implantation (TAVI)

Hemoglobin \<12 g/dL and ≥10 g/dL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit

Evidence of iron deficiency

Able to provide informed consent

Able to understand spoken and written English

Exclusion

Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest

Undergoing heart transplantation or ventricular assist device placement

Lacking capacity to provide informed consent or unable to understand spoken and written English

Baseline hemoglobin \>12 g/dL or \<10 g/dL

Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery

History of hemoglobinopathy

History of hematologic malignancy

Bone marrow suppression from non nutritional causes

Vitamin B12 or folate deficiency

Known liver disease

Known kidney disease

Normal serum iron studies at baseline

What this trial measures

Change in hemoglobin from baseline to day of surgery or procedureFrom the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Change in hemoglobin in grams per deciliter from the baseline pre operative complete blood count to the complete blood count obtained on the day of surgery or procedure. Change will be calculated as hemoglobin on the day of surgery minus baseline hemoglobin.

Trialytics