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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
2 infusions of intravenous iron (ferumoxytol)
University of Rochester
Rochester, New York, United States
Change in hemoglobin from baseline to day of surgery or procedure
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.
Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Treatment compliance
Proportion of participants who complete the assigned iron treatment. Compliance is defined as receiving both infusions in the intravenous arm and taking the prescribed capsules in the oral arm, based on pill counts and participant reporting.
Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Proportion of participants receiving any blood transfusion
Number of participants who receive at least one transfusion of blood products after surgery or procedure
Time frame: From the end of surgery or procedure through thirty days post procedure
Change in iron study values from baseline to the day of surgery or procedure
Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery
Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Post operative complications
Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death.
Time frame: From the end of surgery or procedure through thirty days
Length of intensive care unit stay
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Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge.
Time frame: 30 days after hospital discharge
Length of hospital stay
Duration of hospitalization in days, from admission for surgery or procedure until discharge
Time frame: 30 days after hospital discharge