University of Rochester
Rochester, New York, 14642, United States
Location contact
Marjorie Gloff, MD
CONTACT
Michael Eaton, MD
CONTACT
Michael Eaton, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07287371
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Rochester, New York, 14642, United States
Marjorie Gloff, MD
CONTACT
Michael Eaton, MD
CONTACT
Michael Eaton, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
2 infusions of intravenous iron (ferumoxytol)
Time frame: From 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.
Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
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 end of surgery or procedure through thirty days post procedure
Number of participants who receive at least one transfusion of blood products after surgery or procedure
Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery
Time frame: From the end of surgery or procedure through thirty days
Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death.
Time frame: 30 days after hospital discharge
Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge.
Time frame: 30 days after hospital discharge
Duration of hospitalization in days, from admission for surgery or procedure until discharge
Contact information is provided by the study sponsor or research team.
Marjorie Gloff, MD
CONTACT
Michael Eaton, MD
CONTACT
University of Rochester
Other
Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)
Acronym: RSIVI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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