Sucrosomial Vs Intravenous Iron for Preoperative Anemia
Key facts
- Who runs it
- University of Rochester
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Starts
- 1 Dec 2026
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Treatment with oral sucrosomial iron
- Treatment with intravenous iron
- Record updated
- 6 October 2026
- Why it stopped
- Study withdrawn due to lack of funding and the company's decision not to pursue the IND. No participants were enrolled.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery
- Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest
- Undergoing heart transplantation or ventricular assist device placement
- History of hemoglobinopathy
- History of hematologic malignancy
- Known liver disease
- Known kidney disease
- Baseline hemoglobin >12 g/dL or <10 g/dL
- Normal serum iron studies at baseline
- Lacking capacity to provide informed consent or unable to understand spoken and written English
- Bone marrow suppression from non nutritional causes
- Vitamin B12 or folate deficiency
Where in United States
- University of RochesterRochester, United States
About the trial
What the trial wants to find out
50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.
The 3 groups in the trial
- intravenous (IV) ironExisting treatment, for comparison
If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.
Treatment: Treatment with intravenous iron
- Sucrosomial IronTreatment being tested
If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.
Treatment: Treatment with oral sucrosomial iron
- 3rd arm is for data collection onlyNo study treatment, for comparison
In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)
- Record updated
- 6 October 2026