Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug Treatment with oral sucrosomial iron
  blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
• Drug Treatment with intravenous iron
  2 infusions of intravenous iron (ferumoxytol)

Primary outcome measures

• 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]

Secondary outcome measures (6)

• Treatment compliance [Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks]
• Proportion of participants receiving any blood transfusion [Time frame: 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 [Time frame: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks]
• Post operative complications [Time frame: From the end of surgery or procedure through thirty days]
• Length of intensive care unit stay [Time frame: 30 days after hospital discharge]
• Length of hospital stay [Time frame: 30 days after hospital discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Rochester — Rochester

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07287371 · STUDY00000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗