NCT07287371

Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 surgery, with a dosage of two capsules per day. All other aspects of perioperative care will follow standard practice. A blood sample for complete blood count and iron studies will be obtained on the day of surgery. This is typically collected when the IV is placed, so an additional needle stick is usually not required. Randomization applies only to the two treatment arms (intravenous iron and oral sucrosomial iron). The third arm is a non randomized observational cohort for data collection only.

Conditions

• Anemia
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Treatment with oral sucrosomial iron	blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
DRUG	Treatment with intravenous iron	2 infusions of intravenous iron (ferumoxytol)

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study