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NCT Number: NCT07287371

Sucrosomial Vs Intravenous Iron for Preoperative Anemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Undergoing heart transplantation or ventricular assist device placement
  • Lacking capacity to provide informed consent or unable to understand spoken and written English
  • Baseline hemoglobin >12 g/dL or <10 g/dL
  • Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery
  • History of hemoglobinopathy
  • History of hematologic malignancy
  • Bone marrow suppression from non nutritional causes
  • Vitamin B12 or folate deficiency
  • Known liver disease
  • Known kidney disease
  • Normal serum iron studies at baseline

Treatment and study plan

Treatment with oral sucrosomial iron

Drug

blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies

Treatment with intravenous iron

Drug

2 infusions of intravenous iron (ferumoxytol)

Primary outcomes

  1. Change in hemoglobin from baseline to day of surgery or procedure

    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.

Secondary outcomes

  1. Treatment compliance

    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.

  2. Proportion of participants receiving any blood transfusion

    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

  3. Change in iron study values from baseline to the day of 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

  4. Post operative complications

    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.

  5. Length of intensive care unit stay

    Time frame: 30 days after hospital discharge

    Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge.

  6. Length of hospital stay

    Time frame: 30 days after hospital discharge

    Duration of hospitalization in days, from admission for surgery or procedure until discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Marjorie Gloff, MD

CONTACT

[email protected]

Michael Eaton, MD

CONTACT

[email protected]

585-275-7056

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Pharmanutra S.p.a.

Registry information

Official study title

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

Acronym: RSIVI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

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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