Sucrosomial Vs Intravenous Iron for Preoperative Anemia

NCT07287371 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Iron Deficiency Anemia

Keywords

Anemia; Iron; Transfusion

Outcome Measures

Primary Outcomes (1)

• 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.

  From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks

Secondary Outcomes (6)

• Treatment compliance

  From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks

• Proportion of participants receiving any blood transfusion

  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

  From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks

• Post operative complications

  From the end of surgery or procedure through thirty days

• Length of intensive care unit stay

  30 days after hospital discharge

Study Arms (3)

intravenous (IV) iron

ACTIVE COMPARATOR

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.

Drug: Treatment with intravenous iron

Sucrosomial Iron

EXPERIMENTAL

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.

Drug: Treatment with oral sucrosomial iron

3rd arm is for data collection only

NO INTERVENTION

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.

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

Sucrosomial Iron

Treatment with intravenous iron DRUG

2 infusions of intravenous iron (ferumoxytol)

intravenous (IV) iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Pharmanutra S.p.a.: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (5)

• 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.

  PMID: 31233718 BACKGROUND

• 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.

  PMID: 34194077 BACKGROUND

• 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.

  PMID: 15824508 RESULT

• 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.

  PMID: 33673371 RESULT

• 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.

  PMID: 34710946 RESULT

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

Therapeutics; sucrosomial iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael P Eaton, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Eaton, MD

CONTACT

585-275-7056; michael_eaton@urmc.rochester.edu

Marjorie Gloff, MD

CONTACT

marjorie_gloff@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Observer blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized 1:1 to IV or oral iron. Hemoglobin and iron study outcomes are planned for the two randomized arms. Participants in the non randomized observational arm will contribute these values only if obtained as part of routine clinical care.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)