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| Name | Class |
|---|---|
| Pharmanutra S.p.a. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with oral sucrosomial iron | Drug | blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance | 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. | From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Eaton, MD | Contact | 585-275-7056 | michael_eaton@urmc.rochester.edu | |
| Marjorie Gloff, MD | Contact | marjorie_gloff@urmc.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael P Eaton, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31233718 | Background | 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. | |
| 34194077 | 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. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| C000718012 | sucrosomial iron |
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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.
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Observer blinded
| Treatment with intravenous iron | Drug | 2 infusions of intravenous iron (ferumoxytol) |
|
| Proportion of participants receiving any blood transfusion | Number of participants who receive at least one transfusion of blood products after surgery or procedure | 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 | Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery | From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks |
| Post operative complications | Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death. | From the end of surgery or procedure through thirty days |
| Length of intensive care unit stay | Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge. | 30 days after hospital discharge |
| Length of hospital stay | Duration of hospitalization in days, from admission for surgery or procedure until discharge | 30 days after hospital discharge |
| 15824508 | Result | 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. |
| 33673371 | 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. |
| 34710946 | 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. |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |