Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07287371
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: intravenous (IV) iron
    If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.
  • Experimental: Sucrosomial Iron
    If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.
  • No Intervention: 3rd arm is for data collection only
    In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Michael Eaton, MD
[email protected]
585-275-7056
Marjorie Gloff, MD
[email protected]
Michael Eaton, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Rochester· Rochester, NY

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