Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)
University of Rochester
Summary
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.
Description
Participants will be randomly assigned in a 1 to 1 ratio to one of two treatment groups. One group will receive intravenous (IV) iron, and the other group will receive oral sucrosomial iron. Participants assigned to the IV iron group will receive two infusions at the University of Rochester Medical Center Center for Perioperative Medicine. Intravenous iron will be administered through a small plastic tube placed into a vein. Saline may be used to maintain the IV line as needed. Participants assigned to the oral sucrosomial iron group will receive capsules to take at home until the date of su…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest * Undergoin…
Interventions
- DrugTreatment with oral sucrosomial iron
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
- DrugTreatment with intravenous iron
2 infusions of intravenous iron (ferumoxytol)
Location
- University of RochesterRochester, New York