Sucrosomial Vs Intravenous Iron for Preoperative Anemia
NCT ID: NCT07287371
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2025-12-31
2027-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Treatment with intravenous iron
2 infusions of intravenous iron (ferumoxytol)
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.
Treatment with oral sucrosomial iron
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
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.
No interventions assigned to this group
Interventions
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Treatment with oral sucrosomial iron
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
Treatment with intravenous iron
2 infusions of intravenous iron (ferumoxytol)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pharmanutra S.p.a.
INDUSTRY
University of Rochester
OTHER
Responsible Party
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Michael Eaton
Principal Investigator
Principal Investigators
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Michael P Eaton, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Eaton, MD
Role: primary
Marjorie Gloff, MD
Role: backup
References
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Padmanabhan H, Siau K, Curtis J, Ng A, Menon S, Luckraz H, Brookes MJ. Preoperative Anemia and Outcomes in Cardiovascular Surgery: Systematic Review and Meta-Analysis. Ann Thorac Surg. 2019 Dec;108(6):1840-1848. doi: 10.1016/j.athoracsur.2019.04.108. Epub 2019 Jun 21.
Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.
Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
Bertani L, Trico D, Zanzi F, Baiano Svizzero G, Coppini F, de Bortoli N, Bellini M, Antonioli L, Blandizzi C, Marchi S. Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis. Nutrients. 2021 Feb 12;13(2):608. doi: 10.3390/nu13020608.
Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
Other Identifiers
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STUDY00000
Identifier Type: -
Identifier Source: org_study_id